Pelvic Organ ProlapsePhase 4NCT05658887

Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

A Phase 4 study testing Gabapentin in people with Pelvic Organ Prolapse and Perioperative/Postoperative Complications, run by Joseph Kowalski 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 years and older, women only
Conditions the study is for: Pelvic Organ Prolapse, Perioperative/Postoperative Complications
What is being tested?: Gabapentin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2023to 31 Dec 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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled for a vaginal apical support procedure (sacrospinous ligament fixation or vaginal uterosacral ligament suspension)
Female
Age 18 or higher

Who cannot join

Non-English speaking
Incarcerated
Cognitive impairment precluding informed consent
Chronic opioid user
Chronic gabapentinoid user
Contraindication to acetaminophen, celecoxib, or gabapentinoids
Concurrent laparoscopic or abdominal surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: A Double-Blind Randomized Placebo-Controlled Clinical Trial of Preoperative Gabapentin Prior to Vaginal Apical Suspension Prolapse Procedures

This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperative placebo (both patients and investigators will be blinded). Note the control group will receive preoperative acetaminophen/celecoxib/placebo and the treatment group will receive preoperative acetaminophen/celecoxib/gabapentin (preoperative acetaminophen/celecoxib are part of our current ERAS protocol). The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents.

Read the detailed description

Enhanced Recovery after Surgery (ERAS) is an approach to perioperative care that focuses on evidence-based care protocols that emphasize minimizing stress and improving the body's response to stress. These protocols have resulted in a significant decrease in length of stay, complications, and cost in many different surgical specialities. Many of these protocols (including our current gynecology ERAS protocol) include preoperative gabapentin as an intervention to help reduce postoperative pain and postoperative opioid use. Gabapentin is an anticonvulsant medication that is commonly used for chronic neuropathic pain and other chronic pain disorders. The data regarding perioperative use of gabapentin is currently mixed, and the data in gynecology (and especially urogynecology) is limited. Notably gabapentin has been shown to be associated with sedation, respiratory depression, dizziness, and visual disturbances. In 2019, the U.S. Food and Drug Administration issued a warning that serious breathing difficulties may occur in patients using gabapentin with respiratory risk factors.

Pelvic organ prolapse is a common benign condition, and surgery for pelvic organ prolapse is very common. Vaginal apical suspension is one of the most common surgeries for pelvic organ prolapse. There is very limited data on the utility of preoperative gabapentin for vaginal apical suspension surgery.

Conditions: Pelvic Organ Prolapse, Perioperative/Postoperative Complications
Being tested: Gabapentin, Gabapentin Placebo
Keywords: perioperative pain
Medical subject headings: Pelvic Organ Prolapse, Postoperative Complications

What participants receive

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

GabapentinDrug
Also called FusePaq Fanatrex, Gabarone, Gralise, Neurontin
One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Gabapentin PlaceboDrug
Also called FusePaq Fanatrex Placebo, Gabarone Placebo, Gralise Placebo, Neurontin Placebo
Gabapentin Placebo

Study groups in NCT05658887
Study group	Role	What they receive
Placebo	Placebo comparator	Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Receives: Drug: Gabapentin Placebo
Intervention	Experimental	Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Receives: Drug: Gabapentin

What is being measured

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

Postoperative Opioid Use
Total postoperative opioid use in the first 24 hours postop measured in MME (starting when the patient leaves the operating room)
Measured: 24 hours after surgery. This includes postoperative opioid use in the hospital AND at home (which is why it is different from outcome measure 3).

Secondary outcomes (11)

Mean Postop Pain Score
Mean postoperative pain score (using the validated numerical rating scale, minimum score 0, maximum score 10, higher scores mean worse pain/worse outcome) while admitted in the hospital. Note: this is the mean score while they were postoperatively but median below is correct because we used the median of each individual's MEAN score (this is addressing the comment #10)
Measured: From the time surgery finished to a max of 24 hours after. This was measured by postoperative nursing periodically throughout the postoperative period per standard nursing protocol: usually every hour for the first two hours and then every 4 to 8 hours
Postoperative Opioid Use While Admitted in the Hospital
postoperative opioid use while admitted
Measured: After surgery, max of 24 hours. Note that this is only postoperative opioid use in the hospital. Outcome measure 1 is total postoperative opioid use (in the hospital and at home)
Time to Discharge
Admitted time
Measured: Total admitted time (from admission to the hospital to discharge)
Number of Patients Who Report Postoperative Dizziness
Patient reported postoperative dizziness
Measured: 24 hours postoperative
Number of Patients Who Report Sedation
Patient reported sedation
Measured: 24 hours postoperative
Number of Patients Who Report Visual Changes
Patient reported visual changes
Measured: 24 hours postoperative
Number of Patients Who Report Postoperative Nausea
Patient reported postoperative nausea and vomiting
Measured: 24 hours postoperative
Number of Patients Who Report Postoperative Pain Adequacy
Patient reported postoperative pain adequacy
Measured: 24 hours postoperative
Morphine Milligram Equivalents (MMEs) of Preoperative and Intraoperative Opioids
Amount of opioids (in MMEs) given before and during the surgery
Measured: Preop period to the end of the surgery (any opioids given to the patient from arrival in the hospital to the end of the surgery), on average 5 hours
Estimated Blood Loss
Measured: During the surgery (from surgery start time to surgery end time, this was assessed at the end of the surgery while in the OR), on average 150 minutes
Surgery Length
Measured: During surgery

Timeline

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

1 Jan 202331 Dec 2024

First posted21 Dec 2022
Study start1 Jan 2023
Primary completion31 Dec 2024
Study completion31 Dec 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 (20)Papers the sponsor has linked to this study.
Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05658887
Sponsor's protocol ID: 202207210
Status last verified: Jul 2025
First submitted: 9 Dec 2022
Last updated: 12 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PubMed 28097305
Smith TW Jr, Wang X, Singer MA, Godellas CV, Vaince FT. Enhanced recovery after surgery: A clinical review of implementation across multiple surgical subspecialties. Am J Surg. 2020 Mar;219(3):530-534. doi: 10.1016/j.amjsurg.2019.11.009. Epub 2019 Nov 16.
PubMed 31761300
Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
PubMed 30877144
Altman AD, Robert M, Armbrust R, Fawcett WJ, Nihira M, Jones CN, Tamussino K, Sehouli J, Dowdy SC, Nelson G. Guidelines for vulvar and vaginal surgery: Enhanced Recovery After Surgery Society recommendations. Am J Obstet Gynecol. 2020 Oct;223(4):475-485. doi: 10.1016/j.ajog.2020.07.039. Epub 2020 Jul 24.
PubMed 32717257
Scheib SA, Thomassee M, Kenner JL. Enhanced Recovery after Surgery in Gynecology: A Review of the Literature. J Minim Invasive Gynecol. 2019 Feb;26(2):327-343. doi: 10.1016/j.jmig.2018.12.010. Epub 2018 Dec 20.
PubMed 30580100
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
Mathieson S, Lin CC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020 Apr 28;369:m1315. doi: 10.1136/bmj.m1315. No abstract available.
PubMed 32345589
Doleman B, Heinink TP, Read DJ, Faleiro RJ, Lund JN, Williams JP. A systematic review and meta-regression analysis of prophylactic gabapentin for postoperative pain. Anaesthesia. 2015 Oct;70(10):1186-204. doi: 10.1111/anae.13179. Epub 2015 Aug 24.
PubMed 26300519
Rorarius MG, Mennander S, Suominen P, Rintala S, Puura A, Pirhonen R, Salmelin R, Haanpaa M, Kujansuu E, Yli-Hankala A. Gabapentin for the prevention of postoperative pain after vaginal hysterectomy. Pain. 2004 Jul;110(1-2):175-81. doi: 10.1016/j.pain.2004.03.023.
PubMed 15275765
Hah J, Mackey SC, Schmidt P, McCue R, Humphreys K, Trafton J, Efron B, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Carroll I. Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. JAMA Surg. 2018 Apr 1;153(4):303-311. doi: 10.1001/jamasurg.2017.4915.
PubMed 29238824
Verret M, Lauzier F, Zarychanski R, Perron C, Savard X, Pinard AM, Leblanc G, Cossi MJ, Neveu X, Turgeon AF; Canadian Perioperative Anesthesia Clinical Trials (PACT) Group. Perioperative Use of Gabapentinoids for the Management of Postoperative Acute Pain: A Systematic Review and Meta-analysis. Anesthesiology. 2020 Aug;133(2):265-279. doi: 10.1097/ALN.0000000000003428.
PubMed 32667154
Huynh TQ, Patel NR, Goldstein ND, Makai GE. Preoperative Gabapentin for Minimally Invasive Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):237-244.e2. doi: 10.1016/j.jmig.2020.04.040. Epub 2020 May 8.
PubMed 32389735
Weingarten TN, Jacob AK, Njathi CW, Wilson GA, Sprung J. Multimodal Analgesic Protocol and Postanesthesia Respiratory Depression During Phase I Recovery After Total Joint Arthroplasty. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):330-6. doi: 10.1097/AAP.0000000000000257.
PubMed 25967650
Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214. Obstet Gynecol. 2019 Nov;134(5):e126-e142. doi: 10.1097/AOG.0000000000003519.
PubMed 31651832
Sammarco AG, Swenson CW, Kamdar NS, Kobernik EK, DeLancey JOL, Nallamothu B, Morgan DM. Rate of Pelvic Organ Prolapse Surgery Among Privately Insured Women in the United States, 2010-2013. Obstet Gynecol. 2018 Mar;131(3):484-492. doi: 10.1097/AOG.0000000000002485.
PubMed 29420405

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

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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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind Randomized Placebo-Controlled Clinical Trial of Preoperative Gabapentin Prior to Vaginal Apical Suspension Prolapse Procedures
ClinicalTrials.gov ID: NCT05658887
Acronym / sponsor ID: 202207210
Conditions: Pelvic Organ Prolapse, Perioperative/Postoperative Complications
Keywords: perioperative pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Joseph KowalskiUniversity, hospital or other
Collaborators: University of Iowa
Study start: 1 Jan 2023 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 21 Dec 2022 (actual)
Results: Posted 12 Aug 2025

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Gabapentin PlaceboPreoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo
Intervention	Experimental	Drug: GabapentinPreoperative tylenol, preoperative celecoxib, preoperative gabapentin

Who may qualify

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

Key inclusion criteria (3 listed)

Scheduled for a vaginal apical support procedure (sacrospinous ligament fixation or vaginal uterosacral ligament suspension)
Female
Age 18 or higher

Key exclusion criteria (7 listed)

Non-English speaking
Incarcerated
Cognitive impairment precluding informed consent
Chronic opioid user
Chronic gabapentinoid user

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
GabapentinAlso: FusePaq Fanatrex, Gabarone, Gralise, NeurontinOne dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure	Drug	Intervention
Gabapentin PlaceboAlso: FusePaq Fanatrex Placebo, Gabarone Placebo, Gralise Placebo, Neurontin PlaceboGabapentin Placebo	Drug	Placebo

Primary outcome

Postoperative Opioid Use
Time frame: 24 hours after surgery. This includes postoperative opioid use in the hospital AND at home (which is why it is different from outcome measure 3).
Total postoperative opioid use in the first 24 hours postop measured in MME (starting when the patient leaves the operating room)

11 secondary outcomes

Mean Postop Pain Score
Time frame: From the time surgery finished to a max of 24 hours after. This was measured by postoperative nursing periodically throughout the postoperative period per standard nursing protocol: usually every hour for the first two hours and then every 4 to 8 hours
Postoperative Opioid Use While Admitted in the Hospital
Time frame: After surgery, max of 24 hours. Note that this is only postoperative opioid use in the hospital. Outcome measure 1 is total postoperative opioid use (in the hospital and at home)
Time to Discharge
Time frame: Total admitted time (from admission to the hospital to discharge)
Number of Patients Who Report Postoperative Dizziness
Time frame: 24 hours postoperative
Number of Patients Who Report Sedation
Time frame: 24 hours postoperative
Number of Patients Who Report Visual Changes
Time frame: 24 hours postoperative
Number of Patients Who Report Postoperative Nausea
Time frame: 24 hours postoperative
Number of Patients Who Report Postoperative Pain Adequacy
Time frame: 24 hours postoperative
Morphine Milligram Equivalents (MMEs) of Preoperative and Intraoperative Opioids
Time frame: Preop period to the end of the surgery (any opioids given to the patient from arrival in the hospital to the end of the surgery), on average 5 hours
Estimated Blood Loss
Time frame: During the surgery (from surgery start time to surgery end time, this was assessed at the end of the surgery while in the OR), on average 150 minutes
Surgery Length
Time frame: During surgery

Results and safety

Results posted to the registry on 12 Aug 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
Placebo	52	50
Intervention	55	50

Primary outcome: Postoperative Opioid Use

Time frame: 24 hours after surgery. This includes postoperative opioid use in the hospital AND at home (which is why it is different from outcome measure 3).. Median (Inter-Quartile Range). Unit: MMEs

Measure	Placebo n = 50	Intervention n = 50
Value	25 (13 to 45)	20 (8 to 35)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 hours after surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 50 (0%)	21 of 50 (42%)	0 of 50
Intervention	0 of 50 (0%)	16 of 50 (32%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28097305Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
Background: PubMed 31761300Smith TW Jr, Wang X, Singer MA, Godellas CV, Vaince FT. Enhanced recovery after surgery: A clinical review of implementation across multiple surgical subspecialties. Am J Surg. 2020 Mar;219(3):530-534. doi: 10.1016/j.amjsurg.2019.11.009. Epub 2019 Nov 16.
Background: PubMed 30877144Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
Background: PubMed 32717257Altman AD, Robert M, Armbrust R, Fawcett WJ, Nihira M, Jones CN, Tamussino K, Sehouli J, Dowdy SC, Nelson G. Guidelines for vulvar and vaginal surgery: Enhanced Recovery After Surgery Society recommendations. Am J Obstet Gynecol. 2020 Oct;223(4):475-485. doi: 10.1016/j.ajog.2020.07.039. Epub 2020 Jul 24.
Background: PubMed 30580100Scheib SA, Thomassee M, Kenner JL. Enhanced Recovery after Surgery in Gynecology: A Review of the Literature. J Minim Invasive Gynecol. 2019 Feb;26(2):327-343. doi: 10.1016/j.jmig.2018.12.010. Epub 2018 Dec 20.
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 32345589Mathieson S, Lin CC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020 Apr 28;369:m1315. doi: 10.1136/bmj.m1315. No abstract available.
Background: PubMed 26300519Doleman B, Heinink TP, Read DJ, Faleiro RJ, Lund JN, Williams JP. A systematic review and meta-regression analysis of prophylactic gabapentin for postoperative pain. Anaesthesia. 2015 Oct;70(10):1186-204. doi: 10.1111/anae.13179. Epub 2015 Aug 24.
Background: PubMed 15275765Rorarius MG, Mennander S, Suominen P, Rintala S, Puura A, Pirhonen R, Salmelin R, Haanpaa M, Kujansuu E, Yli-Hankala A. Gabapentin for the prevention of postoperative pain after vaginal hysterectomy. Pain. 2004 Jul;110(1-2):175-81. doi: 10.1016/j.pain.2004.03.023.
Background: PubMed 29238824Hah J, Mackey SC, Schmidt P, McCue R, Humphreys K, Trafton J, Efron B, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Carroll I. Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. JAMA Surg. 2018 Apr 1;153(4):303-311. doi: 10.1001/jamasurg.2017.4915.
Background: PubMed 32667154Verret M, Lauzier F, Zarychanski R, Perron C, Savard X, Pinard AM, Leblanc G, Cossi MJ, Neveu X, Turgeon AF; Canadian Perioperative Anesthesia Clinical Trials (PACT) Group. Perioperative Use of Gabapentinoids for the Management of Postoperative Acute Pain: A Systematic Review and Meta-analysis. Anesthesiology. 2020 Aug;133(2):265-279. doi: 10.1097/ALN.0000000000003428.
Background: PubMed 32389735Huynh TQ, Patel NR, Goldstein ND, Makai GE. Preoperative Gabapentin for Minimally Invasive Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):237-244.e2. doi: 10.1016/j.jmig.2020.04.040. Epub 2020 May 8.
Individual participant dataSharing planned: No

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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.

Joseph Kowalski, MD principal investigator

University of Iowa

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 Gabapentin in people with Pelvic Organ Prolapse and Perioperative/Postoperative Complications, run by Joseph Kowalski 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?

The sponsor lists 3 inclusion and 7 exclusion criteria. 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 12 Aug 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 12 Aug 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?

Postoperative Opioid Use (time frame: 24 hours after surgery. This includes postoperative opioid use in the hospital AND at home (which is why it is different from outcome measure 3).). 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 NCT05658887, which also lists 20 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 12 Aug 2025.