Pelvic Organ ProlapsePhase 4NCT06120530

Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

A Phase 4 study testing Bupivacaine and Saline in people with Pelvic Organ Prolapse, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 90 years, women only
Conditions the study is for: Pelvic Organ Prolapse
What is being tested?: Bupivacaine and Saline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 1 siteUnited States
Study dates: 16 Aug 2023to 15 Mar 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
Women only
No healthy volunteers
Adult, Older adult

4.1 Inclusion Criteria

List the criteria:

Age >= 18 years
Access to cell phone with text messaging capabilities (for same day surgery discharge)
Patients undergoing pelvic organ prolapse repair with peritoneal access 4.2 Exclusion Criteria

List the 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

Trial locations and contacts

1 site in 1 country.

United States1 site

IU north
Carmel, Indiana, 46032

Other trials in United States

About this study

Official title: Effect of Intraperitoneal Bupivacaine on Postoperative Pain Control in Patients Undergoing Pelvic Organ Prolapse Repair

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.

Conditions: Pelvic Organ Prolapse
Being tested: Bupivacaine, Saline
Medical subject headings: Pelvic Organ Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BupivacaineDrug
Intraperitoneal Bupivicaine without epinephrine 30 mg administered following completion of pelvic organ prolapse repair.
SalineOther
Placebo

Study groups in NCT06120530
Study group	Role	What they receive
Intraperitoneal bupivacaine	Active comparator	30 mL of bupivacaine without epinephrine 0.25% Receives: Drug: Bupivacaine
placebo	Placebo comparator	Saline Receives: Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 4 hours

Secondary outcomes (4)

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
Measured: 8 hours, 12 hours and 24 hours
Total Opiate Consumption
Total opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME)
Measured: First 24 hours postoperatively
Time to First Narcotic
Time to first narcotic dose during inpatient stay
Measured: Up to 24 hours
Hospital Length of Stay
Hospital length of stay
Measured: Up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 202315 Mar 2024

First posted7 Nov 2023
Study start16 Aug 2023
Primary completion15 Mar 2024
Study completion15 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06120530
Sponsor's protocol ID: 17120
Status last verified: Apr 2025
First submitted: 29 Jul 2023
Last updated: 20 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 22031616
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.
PubMed 29995737
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.
PubMed 34171879
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.
PubMed 34807884
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.
PubMed 28889218
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.
PubMed 34669653
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.
PubMed 30911646
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.
PubMed 14224216
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.
PubMed 10735797
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.
PubMed 17178187
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.
PubMed 35759786
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.
PubMed 33224238
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.
PubMed 10320172
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.
PubMed 31836291
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.
PubMed 10714840

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration

All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Intraperitoneal Bupivacaine on Postoperative Pain Control in Patients Undergoing Pelvic Organ Prolapse Repair
ClinicalTrials.gov ID: NCT06120530
Acronym / sponsor ID: 17120
Conditions: Pelvic Organ Prolapse
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 16 Aug 2023 (actual)
Primary completion: 15 Mar 2024 (actual)
Study completion: 15 Mar 2024 (actual)
First posted: 7 Nov 2023 (actual)
Results: Posted 20 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intraperitoneal bupivacaine	Active comparator	Drug: Bupivacaine30 mL of bupivacaine without epinephrine 0.25%
placebo	Placebo comparator	Other: SalineSaline

Who may qualify

Ages: 18 to 90 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BupivacaineIntraperitoneal Bupivicaine without epinephrine 30 mg administered following completion of pelvic organ prolapse repair.	Drug	Intraperitoneal bupivacaine
SalinePlacebo	Other	placebo

Primary outcome

Pain Score at 4 Hours
Time frame: 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 secondary outcomes

Pain Score at 8 Hours, 12 Hours and 24 Hours
Time frame: 8 hours, 12 hours and 24 hours
Total Opiate Consumption
Time frame: First 24 hours postoperatively
Time to First Narcotic
Time frame: Up to 24 hours
Hospital Length of Stay
Time frame: Up to 24 hours

Results and safety

Results posted to the registry on 20 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intraperitoneal Bupivacaine	44	44
Placebo	47	47

Primary outcome: Pain Score at 4 Hours

Time frame: 4 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Intraperitoneal Bupivacaine n = 44	Placebo n = 47
Value	3.16 (2.68)	3.77 (2.52)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 6 weeks after surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intraperitoneal Bupivacaine	0 of 44 (0%)	4 of 44 (9.1%)	0 of 44
Placebo	0 of 47 (0%)	1 of 47 (2.1%)	0 of 47

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22031616Melnyk 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.
Background: PubMed 29995737Meyer 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.
Background: PubMed 34171879Pan 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.
Background: PubMed 34807884Mehr 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.
Background: PubMed 28889218Hota 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.
Background: PubMed 34669653Reagan 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.
Background: PubMed 30911646Struller 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.
Background: PubMed 14224216SHEAR 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.
Background: PubMed 10735797Moiniche 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.
Background: PubMed 17178187Lowenstein 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.
Background: PubMed 35759786Zacharakis 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.
Background: PubMed 33224238Zahiri 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.
Individual participant dataSharing planned: No

Related trials for Pelvic Organ Prolapse

Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James R Stewart principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine and Saline in people with Pelvic Organ Prolapse, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score at 4 Hours (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120530, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.