BACKGROUND: A standard approach for postoperative analgesia in laparoscopic surgery is to infiltrate the incisions with local anesthetic in combination with systemic opioids. The intraperitoneal introduction of local anesthetic in this setting has the potential to provide appropriate analgesia without the side effects of systemic opioids. We performed a randomized clinical trial of the On-Q pump delivery system to determine the safety and efficacy of this device for this novel purpose. METHODS:Thirty patients undergoing laparoscopic adjustable gastric banding were randomly assigned to one of two groups. The treatment group received On-Q pump systems filled with 0.375% bupivacaine, while the control group received pumps filled with 0.9% normal saline. The pump's catheter was introduced intraperitoneally, and bupivacaine or saline was then delivered for the first 48 h after surgery. Patient's subjective pain scores were evaluated at preset intervals. In addition, shoulder pain, morphine requirements, and anti-emetic requirements were tabulated. RESULTS: A statistically significant decrease in patient's subjective reports of pain by visual analog score was noted in the On-Q group 1.8+/-1.93 vs. control 3.5+/-2.4, p<0.046 and remained significant until the end of the study (48 h). No statistical difference was noted in shoulder pain, morphine requirements, or anti-emetic requirements at any time point. CONCLUSION: Our trial was able to provide evidence of significant reduction in postoperative pain as measured by subjective pain scores with the use of continuous intraperitoneal bupivacaine using the On-Q pain pump system. Further investigation is warranted to evaluate the cost effectiveness of this technique.
RCT Entities:
BACKGROUND: A standard approach for postoperative analgesia in laparoscopic surgery is to infiltrate the incisions with local anesthetic in combination with systemic opioids. The intraperitoneal introduction of local anesthetic in this setting has the potential to provide appropriate analgesia without the side effects of systemic opioids. We performed a randomized clinical trial of the On-Q pump delivery system to determine the safety and efficacy of this device for this novel purpose. METHODS: Thirty patients undergoing laparoscopic adjustable gastric banding were randomly assigned to one of two groups. The treatment group received On-Q pump systems filled with 0.375% bupivacaine, while the control group received pumps filled with 0.9% normal saline. The pump's catheter was introduced intraperitoneally, and bupivacaine or saline was then delivered for the first 48 h after surgery. Patient's subjective pain scores were evaluated at preset intervals. In addition, shoulder pain, morphine requirements, and anti-emetic requirements were tabulated. RESULTS: A statistically significant decrease in patient's subjective reports of pain by visual analog score was noted in the On-Q group 1.8+/-1.93 vs. control 3.5+/-2.4, p<0.046 and remained significant until the end of the study (48 h). No statistical difference was noted in shoulder pain, morphine requirements, or anti-emetic requirements at any time point. CONCLUSION: Our trial was able to provide evidence of significant reduction in postoperative pain as measured by subjective pain scores with the use of continuous intraperitoneal bupivacaine using the On-Q pain pump system. Further investigation is warranted to evaluate the cost effectiveness of this technique.
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