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Postoperative shoulder pain is often reported to be particularly bothersome after laparoscopy. The benefits of local anesthetic, such as bupivacaine, applied to subcutaneous tissue for general postoperative pain management after surgery is well established. However, there have been no studies on sprayed bupivacaine over the diaphragm to reduce shoulder pain in laparoscopic surgery. The purpose of the study is to evaluate if sprayed infra-diaphragmatic bupivacaine compared to placebo (saline) will improve postoperative shoulder pain in patients undergoing benign laparoscopic gynecologic surgery. The entire study will be conducted at Cedar Sinai Medical Center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine with epinephrine | Experimental | Participants randomized to this arm will have 30 mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) placed over the diaphragm laparoscopically at the conclusion of the laparoscopic gynecologic procedure. |
|
| No intervention | No Intervention | No additional intervention will be performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instillation of Bupivacaine with epinephrine over the diaphragm | Drug | Prior to desufflation of the abdomen during the laparoscopic gynecologic procedure, the surgeon will instill 30mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) laparoscopically aiming to cover the diaphragm with liquid. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative shoulder pain scores | Reported right shoulder pain score using visual analog score (VAS) 24 hours postoperatively Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group Assessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative generalized pain scores | Post-operative generalized pain scores (superiority): Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= pain scores will be lower among the bupivacaine with epinephrine group First and last reported generalized pain score in post-anaesthesia care unit (PACU) using numerical rating score Assessed using the validated 11-point numerical rating scale (0-10), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ogechukwu Ezike, MD | Contact | 3473371181 | ogechukwu.ezike@cshs.org | |
| Kelly Wright, MD | Contact | kelly.wright@cshs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25724402 | Background | Hammer A, Rositch AF, Kahlert J, Gravitt PE, Blaakaer J, Sogaard M. Global epidemiology of hysterectomy: possible impact on gynecological cancer rates. Am J Obstet Gynecol. 2015 Jul;213(1):23-29. doi: 10.1016/j.ajog.2015.02.019. Epub 2015 Feb 25. | |
| 23084671 | Background | Alperin M, Kivnick S, Poon KY. Outpatient laparoscopic hysterectomy for large uteri. J Minim Invasive Gynecol. 2012 Nov-Dec;19(6):689-94. doi: 10.1016/j.jmig.2012.06.007. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2026 | Jan 24, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2026 | Jan 24, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Randomized control trial, single blind study
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Participants are randomized into either the treatment arm with placement of bupivacaine with epinephrine over the diaphragm or the no intervention arm. Participants are blinded to whether or not they received the intervention.
|
| up to 6 hours in post-anaesthesia care unit (PACU) |
| Total analgesic requirements in post-anaesthesia care unit (PACU) in morphine equivalents | Calculated in morphine milligram equivalents (continuous data) Analyzed using the Kruskall-Wallis test (assuming non-normal data) Data will be presented as median (range) | up to 6 hours in post-anaesthesia care unit (PACU) |
| Length of stay in post-anaesthesia care unit (PACU) | Length of stay in post-anaesthesia care unit (PACU) (superiority): Null hypothesis = PACU length of stay will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= PACU length of stay will be shorter in the bupivacaine with epinephrine groups Documented in minutes (continuous data) Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed | up to 6 hours in post-anaesthesia care unit (PACU) |
| Post-operative shoulder pain scores at home | Daily reported post-operative shoulder pain scores at home (superiority): Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group Assessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis | 5 days postoperatively |
| Post-operative opioid use | Post-operative opioid use (superiority): Null hypothesis = post-op opioid use will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= post-op opioid use will be lower among the bupivacaine with epinephrine group Number of pills used reported by patient (interval data) Analyzed using the Kruskall-Wallis test Data will be presented as median (range) | 1 week postoperative |
| Surgical outcome: EBL | Surgical outcomes: EBL (mL) Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group Continuous variables: estimated blood loss Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed | up to 8 hours |
| Surgical outcome: operative time | Surgical outcomes: operative time (minutes) Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group Continuous variables: operative time, estimated blood loss Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed | up to 8 hours |
| Surgical outcome: intraoperative complications | Surgical outcomes: intraoperative complications Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group Binary data: Surgical complications (yes/no) Analyzed using chi-square test | within 1 week of surgery |
| Surgical outcomes: conversion to laparotomy | Surgical outcomes: conversion to laparotomy Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group Binary data: conversion to laparotomy (yes/no) Analyzed using chi-square test | within 6 hours of surgery start time |
| 25655043 | Background | Driessen SR, Baden NL, van Zwet EW, Twijnstra AR, Jansen FW. Trends in the implementation of advanced minimally invasive gynecologic surgical procedures in the Netherlands. J Minim Invasive Gynecol. 2015 May-Jun;22(4):642-7. doi: 10.1016/j.jmig.2015.01.026. Epub 2015 Feb 3. |
| 16625589 | Background | Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003677. doi: 10.1002/14651858.CD003677.pub3. |
| 25884671 | Background | Jaschinski T, Mosch C, Eikermann M, Neugebauer EA. Laparoscopic versus open appendectomy in patients with suspected appendicitis: a systematic review of meta-analyses of randomised controlled trials. BMC Gastroenterol. 2015 Apr 15;15:48. doi: 10.1186/s12876-015-0277-3. |
| 30914471 | Background | Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136/rapm-2018-100024. Epub 2019 Feb 3. |
| 20351978 | Background | Vadivelu N, Mitra S, Narayan D. Recent advances in postoperative pain management. Yale J Biol Med. 2010 Mar;83(1):11-25. |
| 22227789 | Background | American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available. |
| 35973919 | Background | Bougie O, Blom J, Zhou G, Murji A, Thurston J. Use and misuse of opioid after gynecologic surgery. Best Pract Res Clin Obstet Gynaecol. 2022 Dec;85(Pt B):23-34. doi: 10.1016/j.bpobgyn.2022.07.005. Epub 2022 Jul 18. |
| 28043841 | Background | Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30. |
| 33706344 | Background | Clark NV, Moore K, Maghsoudlou P, North A, Ajao MO, Einarsson JI, Louie M, Schiff L, Moawad G, Cohen SL, Carey ET. Superior Hypogastric Plexus Block to Reduce Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2021 Apr 1;137(4):648-656. doi: 10.1097/AOG.0000000000004329. |
| 37004537 | Background | Miao L, Chen Q, Wang Y, Wang D, Zhou M. Effect of intraperitoneal infusion of ropivacaine combined with dexmedetomidine in patients undergoing total laparoscopic hysterectomy: a single-center randomized double-blinded controlled trial. Arch Gynecol Obstet. 2024 Apr;309(4):1387-1393. doi: 10.1007/s00404-023-07020-w. Epub 2023 Apr 1. |
| 27984226 | Background | Patel R, Carvalho JC, Downey K, Kanczuk M, Bernstein P, Siddiqui N. Intraperitoneal Instillation of Lidocaine Improves Postoperative Analgesia at Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2017 Feb;124(2):554-559. doi: 10.1213/ANE.0000000000001799. |
| 32206659 | Background | Cho M, Kim CJ, Hahm TS, Lee YY, Kim TJ, Lee JW, Kim BG, Bae DS, Choi CH. Combination of a pulmonary recruitment maneuver and intraperitoneal bupivacaine for the reduction of postoperative shoulder pain in gynecologic laparoscopy: a randomized, controlled trial. Obstet Gynecol Sci. 2020 Mar;63(2):187-194. doi: 10.5468/ogs.2020.63.2.187. Epub 2020 Feb 20. |
| 23745303 | Background | Sutchritpongsa P, Chaipakdi P, Sirimai K, Chalermchokcharoenkit A, Tanmahasamut P. Intraperitoneal sub-diaphragmatic instillation of bupivacaine plus morphine for reducing postoperative shoulder pain after gynecologic endoscopy. J Med Assoc Thai. 2013 May;96(5):513-8. |
| 23925646 | Background | Roy KK, Subbaiah M, Naha M, Kumar S, Sharma JB, Jahagirdar N. Intraperitoneal bupivacaine for pain relief after minilaparoscopy in patients with infertility. Arch Gynecol Obstet. 2014 Feb;289(2):337-40. doi: 10.1007/s00404-013-2994-6. Epub 2013 Aug 8. |
| 27007272 | Background | Ruiz-Tovar J, Gonzalez J, Garcia A, Cruz C, Rivas S, Jimenez M, Ferrigni C, Duran M. Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery: a Prospective Randomized Clinical Trial. Obes Surg. 2016 Nov;26(11):2616-2621. doi: 10.1007/s11695-016-2142-z. |
| 28669869 | Background | Yong L, Guang B. Intraperitoneal ropivacaine instillation versus no intraperitoneal ropivacaine instillation for laparoscopic cholecystectomy: A systematic review and meta-analysis. Int J Surg. 2017 Aug;44:229-243. doi: 10.1016/j.ijsu.2017.06.043. Epub 2017 Jun 30. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |