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Garen Manvelian - One of the best experts on this subject based on the ideXlab platform.
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evaluation of a single dose extended release epidural morphine formulation for pain after knee arthroplasty
2006Co-Authors: Craig T Hartrick, Gavin Martin, George Kantor, John Koncelik, Garen ManvelianAbstract:Background: DepoDur is a single-dose, extended-release epidural morphine formulation designed to provide forty-eight hours of pain relief. The drug offers potential advantages over continuous epidural infusions, particularly in patients being treated with anticoagulation therapy. The purpose of this study was to evaluate the efficacy and safety of single-dose epidural DepoDur for pain control following knee arthroplasty. Methods: In this multicenter, randomized, double-blind, parallel-group study, patients were randomized to receive a single-dose of DepoDur (20 or 30 mg) or a sham epidural injection thirty minutes before administration of general or regional anesthesia for knee arthroplasty. At their first request for postoperative Analgesia, patients who had received DepoDur were given an Intravenous bolus of hydromorphone followed by placebo Patient-Controlled Analgesia. Patients who had received the sham epidural were given an Intravenous bolus of morphine followed by Patient-Controlled Analgesia with morphine. Patient ratings of pain intensity at rest and with activity, their rating of overall pain control, and postoperative opioid use were recorded. The ability to tolerate physical therapy, the range of motion of the knee, and the need for physical support were assessed as well. Adverse events and vital signs were recorded. Results: Of 168 patients randomized to receive the 20-mg injection of DepoDur, the 30-mg injection of DepoDur, or the sham epidural injection, fifty-one, fifty-eight, and fifty-five patients, respectively, were included in the efficacy analysis. Compared with the patients treated with Intravenous Patient-Controlled Analgesia with morphine, the patients treated with DepoDur had significantly reduced mean pain-intensity-recall scores during the four to eight, four to twelve, four to twenty-four, and four to thirty-hour postdose intervals (p < 0.05 for all comparisons). The patients treated with DepoDur used approximately a threefold lower amount of postoperative opioids in total, with a significant percentage requiring no supplemental opioids. Adverse events common to all groups were nausea (78%), pyrexia (46%), vomiting (43%), pruritus (43%), and hypotension (36%). Respiratory depression was the most common serious adverse event, with serious respiratory depression observed in four DepoDur-treated patients, who were more than sixty-five years of age. Conclusions: With appropriate patient selection and monitoring, perioperative single-dose epidural DepoDur was a safe and effective analgesic alternative to postoperative Intravenous Patient-Controlled Analgesia following knee arthroplasty, with younger patients benefiting from the 20-mg dose. Additional studies of 10 to 15-mg doses for older patients are warranted. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
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forty eight hours of postoperative pain relief after total hip arthroplasty with a novel extended release epidural morphine formulation
2005Co-Authors: Eugene R Viscusi, Craig T Hartrick, Gavin Martin, Neil Singla, Garen ManvelianAbstract:BACKGROUND Epidural morphine has proven analgesic efficacy in the postoperative period and is widely used. This study evaluated the efficacy of extended-release epidural morphine (EREM; DepoDur; Endo Pharmaceuticals Inc., Chadds Ford, PA; SkyePharma, Inc., San Diego, CA) in providing pain relief for 48 h after surgery. METHODS Patients (n = 200) scheduled to undergo total hip arthroplasty were randomized to receive a single dose of 15, 20, or 25 mg EREM or placebo. After surgery and after asking for pain medication, patients had access to Intravenous Patient-Controlled Analgesia fentanyl for breakthrough pain as needed. Postoperative Intravenous Patient-Controlled Analgesia fentanyl use, time to first postoperative fentanyl use, pain intensity at rest and with activity, patient and surgeon ratings of pain control, and adverse events were recorded. RESULTS All EREM dosages reduced the mean (+/- SD) fentanyl use versus placebo (510 +/- 708 vs. 2,091 +/- 1,803 microg; P < 0.0001) and delayed the median time to first dose of fentanyl (21.3 vs. 3.6 h; P < 0.0001). All EREM groups had significantly improved pain control at rest through 48 h postdose (area under the curve [0-48 h]) compared with placebo (P < 0.0005). More EREM-treated patients rated their pain control as good or very good compared with placebo (at 24 h: 90 vs. 65%, P < 0.0001; at 48 h: 83 vs. 67%, P < 0.05). No supplemental Analgesia was needed in 25% of EREM-treated patients and 2% of placebo-treated patients at 48 h (P < 0.05). The safety profile of EREM was consistent with that of other epidurally administered opioid analgesics. CONCLUSIONS EREM provided significant postoperative pain relief over a 48-h period after hip surgery, without the need for indwelling epidural catheters.
Craig T Hartrick - One of the best experts on this subject based on the ideXlab platform.
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fentanyl iontophoretic transdermal system for acute pain management after orthopedic surgery a comparative study with morphine Intravenous patient controlled Analgesia
2006Co-Authors: Craig T Hartrick, C V Damaraju, Susan Vallow, Kathryn Gargiulo, Michael H. Bourne, David J. HewittAbstract:Background and Objectives The fentanyl HCl iontophoretic transdermal system (ITS) has been demonstrated in clinical trials to be safe and effective for acute-pain management after several types of major surgery. The current study compared the efficacy, safety, and convenience of fentanyl ITS with morphine Intravenous Patient-Controlled Analgesia (IV PCA) for acute-pain management after unilateral total-hip replacement (THR). Methods In this multicenter (52 sites), randomized, open-label, active-controlled, phase IIIb study, patients (n = 799) received fentanyl ITS (40 μg fentanyl [10-minute infusion/lockout], up to 6 doses/h) or morphine IV PCA (1-mg morphine bolus [5-minute lockout], up to 10 mg/h) after unilateral THR. The primary efficacy measure was success ratings (“excellent” or “good”) on the patient global assessment (PGA) of the method of pain control in the first 24 hours. Pain intensity and adverse events were also assessed. Results The PGA success ratings (83.0% v 82.2%; difference = 0.9%; 95% CI: −4.4% to 6.1%) and the mean last pain-intensity scores (3.0 v 3.0; difference = 0.0; 95% CI: −0.33 to 0.33) in the first 24 hours were statistically equivalent between fentanyl ITS and morphine IV PCA groups, respectively. The incidence of adverse events was similar between the groups. Conclusions Results of this study demonstrate fentanyl ITS and a standard regimen of morphine IV PCA were comparable methods of pain control for management of acute postoperative pain after THR, on the basis of the PGA success ratings and pain intensity in the first 24 hours of treatment.
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evaluation of a single dose extended release epidural morphine formulation for pain after knee arthroplasty
2006Co-Authors: Craig T Hartrick, Gavin Martin, George Kantor, John Koncelik, Garen ManvelianAbstract:Background: DepoDur is a single-dose, extended-release epidural morphine formulation designed to provide forty-eight hours of pain relief. The drug offers potential advantages over continuous epidural infusions, particularly in patients being treated with anticoagulation therapy. The purpose of this study was to evaluate the efficacy and safety of single-dose epidural DepoDur for pain control following knee arthroplasty. Methods: In this multicenter, randomized, double-blind, parallel-group study, patients were randomized to receive a single-dose of DepoDur (20 or 30 mg) or a sham epidural injection thirty minutes before administration of general or regional anesthesia for knee arthroplasty. At their first request for postoperative Analgesia, patients who had received DepoDur were given an Intravenous bolus of hydromorphone followed by placebo Patient-Controlled Analgesia. Patients who had received the sham epidural were given an Intravenous bolus of morphine followed by Patient-Controlled Analgesia with morphine. Patient ratings of pain intensity at rest and with activity, their rating of overall pain control, and postoperative opioid use were recorded. The ability to tolerate physical therapy, the range of motion of the knee, and the need for physical support were assessed as well. Adverse events and vital signs were recorded. Results: Of 168 patients randomized to receive the 20-mg injection of DepoDur, the 30-mg injection of DepoDur, or the sham epidural injection, fifty-one, fifty-eight, and fifty-five patients, respectively, were included in the efficacy analysis. Compared with the patients treated with Intravenous Patient-Controlled Analgesia with morphine, the patients treated with DepoDur had significantly reduced mean pain-intensity-recall scores during the four to eight, four to twelve, four to twenty-four, and four to thirty-hour postdose intervals (p < 0.05 for all comparisons). The patients treated with DepoDur used approximately a threefold lower amount of postoperative opioids in total, with a significant percentage requiring no supplemental opioids. Adverse events common to all groups were nausea (78%), pyrexia (46%), vomiting (43%), pruritus (43%), and hypotension (36%). Respiratory depression was the most common serious adverse event, with serious respiratory depression observed in four DepoDur-treated patients, who were more than sixty-five years of age. Conclusions: With appropriate patient selection and monitoring, perioperative single-dose epidural DepoDur was a safe and effective analgesic alternative to postoperative Intravenous Patient-Controlled Analgesia following knee arthroplasty, with younger patients benefiting from the 20-mg dose. Additional studies of 10 to 15-mg doses for older patients are warranted. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
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forty eight hours of postoperative pain relief after total hip arthroplasty with a novel extended release epidural morphine formulation
2005Co-Authors: Eugene R Viscusi, Craig T Hartrick, Gavin Martin, Neil Singla, Garen ManvelianAbstract:BACKGROUND Epidural morphine has proven analgesic efficacy in the postoperative period and is widely used. This study evaluated the efficacy of extended-release epidural morphine (EREM; DepoDur; Endo Pharmaceuticals Inc., Chadds Ford, PA; SkyePharma, Inc., San Diego, CA) in providing pain relief for 48 h after surgery. METHODS Patients (n = 200) scheduled to undergo total hip arthroplasty were randomized to receive a single dose of 15, 20, or 25 mg EREM or placebo. After surgery and after asking for pain medication, patients had access to Intravenous Patient-Controlled Analgesia fentanyl for breakthrough pain as needed. Postoperative Intravenous Patient-Controlled Analgesia fentanyl use, time to first postoperative fentanyl use, pain intensity at rest and with activity, patient and surgeon ratings of pain control, and adverse events were recorded. RESULTS All EREM dosages reduced the mean (+/- SD) fentanyl use versus placebo (510 +/- 708 vs. 2,091 +/- 1,803 microg; P < 0.0001) and delayed the median time to first dose of fentanyl (21.3 vs. 3.6 h; P < 0.0001). All EREM groups had significantly improved pain control at rest through 48 h postdose (area under the curve [0-48 h]) compared with placebo (P < 0.0005). More EREM-treated patients rated their pain control as good or very good compared with placebo (at 24 h: 90 vs. 65%, P < 0.0001; at 48 h: 83 vs. 67%, P < 0.05). No supplemental Analgesia was needed in 25% of EREM-treated patients and 2% of placebo-treated patients at 48 h (P < 0.05). The safety profile of EREM was consistent with that of other epidurally administered opioid analgesics. CONCLUSIONS EREM provided significant postoperative pain relief over a 48-h period after hip surgery, without the need for indwelling epidural catheters.
Engelbert Deusch - One of the best experts on this subject based on the ideXlab platform.
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superior postoperative pain relief with thoracic epidural Analgesia versus Intravenous patient controlled Analgesia after minimally invasive pectus excavatum repair
2007Co-Authors: Thomas Weber, Johanna Matzl, Alexander Rokitansky, Walter Klimscha, Konrad Neumann, Engelbert DeuschAbstract:Objective Minimally invasive pectus excavatum repair is a common and painful surgical procedure in children and adolescents. Adequate postoperative pain therapy is important far beyond the immediate postoperative period because sensitization to painful stimuli can cause chronic pain or higher pain levels during subsequent surgical procedures. Although data in adults favor thoracic epidural anesthesia for pain control in thoracotomy, data for adolescents and children are scarce. We tested the hypothesis that pain relief with thoracic epidural Analgesia was superior to that with Intravenous Patient-Controlled Analgesia after minimally invasive pectus excavatum repair in children and adolescents. Methods We performed a prospective randomized trial with adolescents who had undergone minimally invasive pectus excavatum repair to compare postoperative pain using two different postoperative pain therapy settings: Intravenous Patient-Controlled Analgesia (n = 20) with morphine versus continuous thoracic epidural Analgesia (n = 20) with 0.2% ropivacain containing 2 μg/mL fentanyl. Results Forty patients (32 male and 8 female patients) aged 10 to 28 years were studied. The thoracic epidural Analgesia group showed lower pain scores ( P P P = .38), nausea ( P = .10), and pruritus ( P = .72) in both groups. Conclusions For adolescents undergoing minimally invasive pectus excavatum repair, thoracic epidural Analgesia was superior to Intravenous Patient-Controlled Analgesia for postoperative Analgesia, resulting in lower postoperative pain scores in conjunction with greater well-being.
Kristin Cheung - One of the best experts on this subject based on the ideXlab platform.
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efficacy of postoperative patient controlled and continuous infusion epidural Analgesia versus Intravenous patient controlled Analgesia with opioids a meta analysis
2005Co-Authors: Seth R Cohen, Jeffrey M Richman, Andrew J Rowlingson, Genevieve E Courpas, Kristin Cheung, Elaina E Lin, Spencer S LiuAbstract:The authors performed a meta-analysis and found that epidural Analgesia overall provided superior postoperative Analgesia compared with Intravenous Patient-Controlled Analgesia. For all types of surgery and pain assessments, all forms of epidural Analgesia (both continuous epidural infusion and Patient-Controlled epidural Analgesia) provided significantly superior postoperative Analgesia compared with Intravenous Patient-Controlled Analgesia, with the exception of hydrophilic opioid-only epidural regimens. Continuous epidural infusion provided statistically significantly superior Analgesia versus Patient-Controlled epidural Analgesia for overall pain, pain at rest, and pain with activity; however, patients receiving continuous epidural infusion had a significantly higher incidence of nausea-vomiting and motor block but lower incidence of pruritus. In summary, almost without exception, epidural Analgesia, regardless of analgesic agent, epidural regimen, and type and time of pain assessment, provided superior postoperative Analgesia compared to Intravenous Patient-Controlled Analgesia.
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efficacy of postoperative patient controlled and continuous infusion epidural Analgesia versus Intravenous patient controlled Analgesia with opioids a meta analysis
2005Co-Authors: Christopher L Wu, Seth R Cohen, Jeffrey M Richman, Andrew J Rowlingson, Genevieve E Courpas, Kristin CheungAbstract:The authors performed a meta-analysis and found that epidural Analgesia overall provided superior postoperative Analgesia compared with Intravenous Patient-Controlled Analgesia. For all types of surgery and pain assessments, all forms of epidural Analgesia (both continuous epidural infusion and pati
Daniel Joris - One of the best experts on this subject based on the ideXlab platform.
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effects of Intravenous patient controlled Analgesia with morphine continuous epidural Analgesia and continuous femoral nerve sheath block on rehabilitation after unilateral total hip arthroplasty
2005Co-Authors: Francois Singelyn, Tanguy Ferrant, Marie F Malisse, Daniel JorisAbstract:BACKGROUND AND OBJECTIVES: Regional analgesic techniques allow better postoperative rehabilitation and shorter hospital stay after major knee surgery. The authors tested the hypothesis that similar results could be obtained after total-hip arthroplasty. METHODS: Forty-five patients scheduled for THA under general anesthesia were randomly divided into 3 groups. Postoperative Analgesia was provided during the first 48 hours, with Intravenous Patient-Controlled Analgesia (IV PCA) induced by morphine (dose, 1.5 mg; lockout interval, 8 min) in group IV, continuous femoral nerve sheath block in group FNB, and continuous epidural Analgesia in group EPI. The day after surgery, the 3 groups started identical physical therapy regimens. Pain scores at rest and on movement, supplemental Analgesia, side effects, daily degree of maximal hip flexion and abduction, day of first walk, and duration of hospital stay were recorded. RESULTS: Population data, quality of pain relief, postoperative hip rehabilitation, and duration of hospital stay were comparable in the 3 groups. When compared with the two other techniques, continuous FNB was associated with a lower incidence of side effects (no nausea/vomiting, urinary retention, arterial hypotension, or catheter problem during the first 48 hours in 20%, 60%, and 13% of patients in groups IV, FNB, and EPI, respectively). CONCLUSIONS: This study suggests that IV PCA with morphine, continuous FNB, and continuous epidural Analgesia provide similar pain relief and allow comparable hip rehabilitation and duration of hospital stay after total-hip arthroplasty (THA). As continuous FNB is associated with less side effects, it appears to offer the best option of the three.
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effects of Intravenous patient controlled Analgesia with morphine continuous epidural Analgesia and continuous three in one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty
1998Co-Authors: Francois Singelyn, Daniel Joris, M Deyaert, Etienne Pendeville, Jeanmarie GouverneurAbstract:In this study, we assessed the influence of three analgesic techniques on postoperative knee rehabilitation after total knee arthroplasty (TKA). Forty-five patients scheduled for elective TKA under general anesthesia were randomly divided into three groups. Postoperative Analgesia was provided with i.v. Patient-Controlled Analgesia (PCA) with morphine in Group A, continuous 3-in-1 block in Group B, and epidural Analgesia in Group C. Immediately after surgery, the three groups started identical physical therapy regimens. Pain scores, supplemental Analgesia, side effects, degree of maximal knee flexion, day of first walk, and duration of hospital stay were recorded. Patients in Groups B and C reported significantly lower pain scores than those in Group A. Supplemental Analgesia was comparable in the three groups. Compared with Groups A and C, a significantly lower incidence of side effects was noted in Group B. Significantly better knee flexion (until 6 wk after surgery), faster ambulation, and shorter hospital stay were noted in Groups B and C. However, these benefits did not affect outcome at 3 mo. We conclude that, after TKA, continuous 3-in-1 block and epidural Analgesia provide better pain relief and faster knee rehabilitation than i.v. PCA with morphine. Because it induces fewer side effects, continuous 3-in-1 block should be considered the technique of choice. Implications: In this study, we determined that, after total knee arthroplasty, loco-regional analgesic techniques (epidural Analgesia or continuous 3-in-1 block) provide better pain relief and faster postoperative knee rehabilitation than i.v. Patient-Controlled Analgesia with morphine. Because it causes fewer side effects than epidural Analgesia, continuous 3-in-1 block is the technique of choice.