Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
91 participants
INTERVENTIONAL
2023-08-16
2024-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intraperitoneal bupivacaine
30 mL of bupivacaine without epinephrine 0.25%
Bupivacaine
Intraperitoneal Bupivicaine without epinephrine 30 mg administered following completion of pelvic organ prolapse repair.
placebo
Saline
Saline
Placebo
Interventions
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Bupivacaine
Intraperitoneal Bupivicaine without epinephrine 30 mg administered following completion of pelvic organ prolapse repair.
Saline
Placebo
Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years
* Access to cell phone with text messaging capabilities (for same day surgery discharge)
Exclusion Criteria
* Bupivacaine allergy
* History of epilepsy or other seizure disorder
* EKG demonstrating asymptomatic sinus bradycardia \<40 bpm, symptomatic sinus bradycardia \<60 bpm, first degree AV block, second degree AV block, third degree AV block, prolonged QT, atrial fibrillation, supraventricular tachycardia, or myocardial infarction
* Chronic liver disease proved by any ALT or AST elevation greater than 2x upper limit of normal
* Serum bilirubin elevation in excess of 5 mg/dL
* G6PD deficiency
* Weight less than 100 lbs
* Chronic opiate use
18 Years
90 Years
FEMALE
No
Sponsors
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Indiana University
OTHER
Responsible Party
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James Ryan Stewart
Assistant Professor of Clinical Obstetrics & Gynecology
Principal Investigators
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James R Stewart
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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IU north
Carmel, Indiana, United States
Countries
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References
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Melnyk M, Casey RG, Black P, Koupparis AJ. Enhanced recovery after surgery (ERAS) protocols: Time to change practice? Can Urol Assoc J. 2011 Oct;5(5):342-8. doi: 10.5489/cuaj.11002.
Meyer LA, Lasala J, Iniesta MD, Nick AM, Munsell MF, Shi Q, Wang XS, Cain KE, Lu KH, Ramirez PT. Effect of an Enhanced Recovery After Surgery Program on Opioid Use and Patient-Reported Outcomes. Obstet Gynecol. 2018 Aug;132(2):281-290. doi: 10.1097/AOG.0000000000002735.
Pan C, Hale D, Heit M. Enhanced Recovery Protocol Enhances Postdischarge Recovery After Laparoscopic Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):667-671. doi: 10.1097/SPV.0000000000001042.
Mehr AA, Elmer-Lyon C, Maetzold E, Bradley CS, Kowalski JT. Effect of Enhanced Recovery Protocol on Opioid Use in Pelvic Organ Prolapse Surgery. Female Pelvic Med Reconstr Surg. 2021 Dec 1;27(12):e705-e709. doi: 10.1097/SPV.0000000000001114.
Hota LS, Warda HA, Haviland MJ, Searle FM, Hacker MR. Opioid use following gynecologic and pelvic reconstructive surgery. Int Urogynecol J. 2018 Oct;29(10):1441-1445. doi: 10.1007/s00192-017-3474-5. Epub 2017 Sep 9.
Reagan KML, Boyles SH, Brueseke TJ, Linder BJ, Willis-Gray MG, Cichowski SB, Long JB. Postoperative Opioid Prescribing After Female Pelvic Medicine and Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):643-653. doi: 10.1097/SPV.0000000000001113.
Struller F, Weinreich FJ, Horvath P, Kokkalis MK, Beckert S, Konigsrainer A, Reymond MA. Peritoneal innervation: embryology and functional anatomy. Pleura Peritoneum. 2017 Dec 1;2(4):153-161. doi: 10.1515/pp-2017-0024.
SHEAR L, SWARTZ C, SHINABERGER JA, BARRY KG. KINETICS OF PERITONEAL FLUID ABSORPTION IN ADULT MAN. N Engl J Med. 1965 Jan 21;272:123-7. doi: 10.1056/NEJM196501212720303. No abstract available.
Moiniche S, Jorgensen H, Wetterslev J, Dahl JB. Local anesthetic infiltration for postoperative pain relief after laparoscopy: a qualitative and quantitative systematic review of intraperitoneal, port-site infiltration and mesosalpinx block. Anesth Analg. 2000 Apr;90(4):899-912. doi: 10.1097/00000539-200004000-00024.
Lowenstein L, Zimmer EZ, Deutsch M, Paz Y, Yaniv D, Jakobi P. Preoperative analgesia with local lidocaine infiltration for abdominal hysterectomy pain management. Eur J Obstet Gynecol Reprod Biol. 2008 Feb;136(2):239-42. doi: 10.1016/j.ejogrb.2006.11.008. Epub 2006 Dec 18.
Zacharakis D, Prodromidou A, Douligeris A, Athanasiou S, Hadzilia S, Kathopoulis N, Athanasiou V, Grigoriadis T. Preemptive Infiltration of Local Anesthetics During Vaginal Hysterectomy: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Urogynecology (Phila). 2022 Oct 1;28(10):667-678. doi: 10.1097/SPV.0000000000001221. Epub 2022 Jun 27.
Zahiri Sorouri Z, Milani F, Heidarzadeh A, Akhavan Azari M. Intraperitoneal Instillation of Lidocaine for Postoperative Pain Relief after Total Abdominal Hysterectomy: A Double Blinded Randomized Placebo-controlled Trial. Iran J Pharm Res. 2020 Spring;19(2):317-322. doi: 10.22037/ijpr.2020.1101084.
Visalyaputra S, Lertakyamanee J, Pethpaisit N, Somprakit P, Parakkamodom S, Suwanapeum P. Intraperitoneal lidocaine decreases intraoperative pain during postpartum tubal ligation. Anesth Analg. 1999 May;88(5):1077-80. doi: 10.1097/00000539-199905000-00020.
Safari S, Rokhtabnak F, Djalali Motlagh S, Ghanbari Garkani M, Pournajafian A. Effect of intraperitoneal bupivacaine on postoperative pain in laparoscopic bariatric surgeries. Surg Obes Relat Dis. 2020 Feb;16(2):299-305. doi: 10.1016/j.soard.2019.10.028. Epub 2019 Nov 7.
Elhakim M, Elkott M, Ali NM, Tahoun HM. Intraperitoneal lidocaine for postoperative pain after laparoscopy. Acta Anaesthesiol Scand. 2000 Mar;44(3):280-4. doi: 10.1034/j.1399-6576.2000.440310.x.
Williams DJ, Walker JD. A nomogram for calculating the maximum dose of local anaesthetic. Anaesthesia. 2014 Aug;69(8):847-53. doi: 10.1111/anae.12679. Epub 2014 May 12.
Kahokehr A, Sammour T, Vather R, Taylor M, Stapelberg F, Hill AG. Systemic levels of local anaesthetic after intra-peritoneal application--a systematic review. Anaesth Intensive Care. 2010 Jul;38(4):623-38. doi: 10.1177/0310057X1003800404.
Bahrami, Z H, et al. "Evaluation of Lidocaine and Bupivacaine in Post Operation Pain after Abdominal Hysterectomy." Journal of Mazandaran University of Medical Sciences, vol. 16, no. 53, Aug. 2006, pp. 1-8., http://jmums.mazums.ac.ir/article-1-899-en.html.
Shalan, Hesham, et al. "Effect of Intraperitoneal Bupivacaine on Postoperative Pain Following Laparoscopic Pelvic Surgery." Gynaecological Endoscopy, vol. 11, no. 6, 2002, pp. 371-375., https://doi.org/10.1111/j.1365-2508.2002.00557.x.
Datta, Pramatha Nath, and Arijit Roy. "Role of Intraperitoneal Instillation of Bupivacaine after Laparoscopic Cholecystectomy for Post-Operative Pain Management: A Randomized Controlled Trial." International Surgery Journal, vol. 7, no. 10, 2020, p. 3239., https://doi.org/10.18203/2349-2902.isj20203986.
Al Kizwini, Ghassan. "Intra-Peritoneal Xylocaine Spraying for Postoperative Pain Control in Laparoscopic Cholecystectomy: A Prospective Study at Al-Yarmouk Teaching Hospital." Mustansiriya Medical Journal, vol. 16, no. 3, Dec. 2017, pp. 83-90., https://www.iasj.net/iasj/download/85fb88f576d0dfbc.
Alemrajabi, Mahdi, et al. "Intraperitoneal Lavage with Bupivacaine 0.2% and Post-Operative Pain in Laparoscopic Colorectal Surgery: A Prospective, Double-Blind, Randomized Controlled Trial." Journal of Kerman University of Medical Sciences, vol. 27, no. 6, 29 Sept. 2020, pp. 510-519., https://doi.org/10.22062/JKMU.2020.91526.
Darwish, Atef M., and Zein E. Zareh Hassan. "Intraperitoneal Bupivacaine vs. Tramadol for Pain Relief Following Day Case Laparoscopic Surgery." Gynaecological Endoscopy, vol. 8, no. 3, 1999, pp. 169-173., https://doi.org/10.1046/j.1365-2508.1999.00249.x.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17120
Identifier Type: -
Identifier Source: org_study_id
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