Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effects of 30 mL intraperitoneal Bupivacaine without epinephrine 0.25% on postoperative pain control in patients undergoing pelvic organ prolapse repair. The investigators hypothesize that use of intraperitoneal Bupivacaine will decrease postoperative pain scores and opiate consumption in the postoperative period, following pelvic organ prolapse repair.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal bupivacaine | Active Comparator | 30 mL of bupivacaine without epinephrine 0.25% |
|
| placebo | Placebo Comparator | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Intraperitoneal Bupivicaine without epinephrine 30 mg administered following completion of pelvic organ prolapse repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at 4 Hours | Patient pain will be measured by means of a numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at 4 hours after surgical pelvic organ prolapse repair | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at 8 Hours, 12 Hours and 24 Hours | Pain scores as determined by numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at approximately 8, 12 and 24 hours | 8 hours, 12 hours and 24 hours |
| Total Opiate Consumption |
Not provided
4.1 Inclusion Criteria
List the criteria:
List the criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James R Stewart | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU north | Carmel | Indiana | 46032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22031616 | Background | 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. | |
| 29995737 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All participants underwent pelvic organ prolapse surgery at one academic medical center from August 16, 2023, to March 14, 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intraperitoneal Bupivacaine | This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access. |
| FG001 | Placebo | This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intraperitoneal Bupivacaine | This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score at 4 Hours | Patient pain will be measured by means of a numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at 4 hours after surgical pelvic organ prolapse repair | Posted | Mean | Standard Deviation | score on a scale | 4 hours |
|
up to 6 weeks after surgery
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intraperitoneal Bupivacaine | This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Renal and urinary disorders | Non-systematic Assessment | Postoperative incomplete bladder emptying |
Limitations of this study include the lack of preoperative baseline pain assessment. Additionally, because pain assessments were obtained based on surgery end time, there is likely some variability in the time interval between intervention administration and pain assessment. Lastly, time to first narcotic dose could only be assessed among those that required opioids inpatient, thus resulting in lower power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Lazaro | Indiana University School of Medicine | 7274241947 | jlazarow@iu.edu |
Not provided
| 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 | May 25, 2023 | Feb 10, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline | Other | Placebo |
|
Total opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME) |
| First 24 hours postoperatively |
| Time to First Narcotic | Time to first narcotic dose during inpatient stay | Up to 24 hours |
| Hospital Length of Stay | Hospital length of stay | Up to 24 hours |
| 34171879 | Background | 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. |
| 34807884 | Background | 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. |
| 28889218 | Background | 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. |
| 34669653 | Background | 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. |
| 30911646 | Background | 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. |
| 14224216 | Background | 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. |
| 10735797 | Background | 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. |
| 17178187 | Background | 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. |
| 35759786 | Background | 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. |
| 33224238 | Background | 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. |
| 10320172 | Background | 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. |
| 31836291 | Background | 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. |
| 10714840 | Background | 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. |
| 24820093 | Background | 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. |
| 20715724 | Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | 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. |
This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoking status | Count of Participants | Participants |
|
| Menopausal status | Count of Participants | Participants |
|
| Primary surgical intervention | Count of Participants | Participants |
|
| Concomitant surgeries | Count of Participants | Participants |
|
| Stage of prolapse | Pelvic organ prolapse is staged from 0-4 based on the maximal extent of the prolapse leading edge. Stage 0 is no prolapse. Stage 1 is defined as the most distal part of the prolapsed organ is more than 1 cm above the hymen. Stage 2 is defined as the most distal part of the prolapsed organ is between 1 cm above and 1 cm below the hymen. Stage 3 is defined as the most distal part of the prolapsed organ is more than 1 cm below the hymen, but not within 2 cm of the total vaginal length. Stage IV is defined as the most distal part of the prolapse being within 2 cm of the total vaginal length. | Count of Participants | Participants |
|
|
|
| Secondary | Pain Score at 8 Hours, 12 Hours and 24 Hours | Pain scores as determined by numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at approximately 8, 12 and 24 hours | Posted | Mean | Standard Deviation | score on a scale | 8 hours, 12 hours and 24 hours |
|
|
|
| Secondary | Total Opiate Consumption | Total opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME) | Posted | Mean | Standard Deviation | Morphine milligram equivalents | First 24 hours postoperatively |
|
|
|
| Secondary | Time to First Narcotic | Time to first narcotic dose during inpatient stay | Posted | Mean | Standard Deviation | Minutes | Up to 24 hours |
|
|
|
| Secondary | Hospital Length of Stay | Hospital length of stay | Posted | Mean | Standard Deviation | Days | Up to 24 hours |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 4 |
| 44 |
| EG001 | Placebo | This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access. | 0 | 47 | 0 | 47 | 1 | 47 |
|
| Other | Renal and urinary disorders | Non-systematic Assessment | Postoperative acute kidney injury suspected to be from hypovolemia during surgery. |
|
| Other | Gastrointestinal disorders | Non-systematic Assessment | Postoperative ileus |
|
| Other | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash suspected to be from surgical drapes |
|
Not provided
Not provided
Not provided
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| 24-hour |
|