Postoperative PainPhase 4NCT05494385
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
A Phase 4 study testing Preoperative Gabapentin/Postoperative Gabapentin in people with Postoperative Pain, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Preoperative Gabapentin/Postoperative Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2021to 5 Jul 2023
- 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
- Women > 18 years old
- English-speaking
- Stage > 2 pelvic organ prolapse
- Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure)
- Planning overnight stay
Who cannot join
- Renal dysfunction (creatinine clearance <60 mL/min)
- Allergy to acetaminophen and ibuprofen
- Allergy to gabapentin
- Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.
- Conditions
- Postoperative Pain
- Being tested
- Preoperative Gabapentin/Postoperative Placebo, Preoperative Gabapentin/Postoperative Gabapentin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Gabapentin/Postoperative PlaceboDrug
Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
Preoperative Gabapentin/Postoperative GabapentinDrug
Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Placebo comparator | Not described Receives: Drug: Preoperative Gabapentin/Postoperative Placebo |
| Preoperative Gabapentin/Postoperative Gabapentin | Active comparator | Not described Receives: Drug: Preoperative Gabapentin/Postoperative Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Prescription at Discharge
Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.
Measured: Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)
Secondary outcomes (6)
Opioid Refill Requests
Number of patients in each group who call the office to request a new opioid prescription (if they were discharged without a prescription) or to request an opioid prescription refill (if they were discharged with a prescription) within the 6-week postoperative time period.
Measured: 6 weeks
Inpatient Pain Scores
Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 being no pain and 10 being worst pain. Highest pain score recorded.
Measured: Length of postoperative hospital stay (an average of 32 hours following surgery)
Inpatient Morphine Milligram Equivalents
Total morphine milligram equivalents used will be calculated by converting total PO and IV opioids used postoperatively until hospital discharge to morphine milligram equivalents using the opioid equianalgesic chart.
Measured: Length of postoperative hospital stay (an average of 32 hours following surgery)
Length of Stay
Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.
Measured: Time of registration for surgery to time of discharge from hospital
Nausea
Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.
Measured: Length of postoperative hospital stay (an average of 32 hours following surgery)
Sedation
Sedation will be measured by the Stanford Sleepiness Scale. This is a self-administered scale that the patient will complete at 10AM on postoperative day 1.
Measured: On postoperative day 1 between 6AM and 10AM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start27 Jul 2021
- Primary completion17 Jun 2023
- Study completion5 Jul 2023
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 (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglass Hale, Indiana University
- Investigators
- Douglass S Hale, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494385
- Sponsor's protocol ID
- OBGYN-IIR-PERI-OP-GABAPENTIN
- Status last verified
- Oct 2024
- First submitted
- 8 Aug 2022
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guanzon A, Hale D, Morse D, Bhamidipalli SS, Guise D, Hamner J, Heit M. Perioperative Gabapentin and Opioid Requirements: A Randomized Controlled Trial. Urogynecology (Phila). 2026 Jun 15. doi: 10.1097/SPV.0000000000001891. Online ahead of print.
PubMed 42294807
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
- ClinicalTrials.gov ID
- NCT05494385
- Acronym / sponsor ID
- OBGYN-IIR-PERI-OP-GABAPENTIN
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 17 Jun 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.
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 |
|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Placebo comparator | Drug: Preoperative Gabapentin/Postoperative Placebo |
| Preoperative Gabapentin/Postoperative Gabapentin | Active comparator | Drug: Preoperative Gabapentin/Postoperative Gabapentin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women > 18 years old
- English-speaking
- Stage > 2 pelvic organ prolapse
- Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure)
- Planning overnight stay
Key exclusion criteria (4 listed)
- Renal dysfunction (creatinine clearance <60 mL/min)
- Allergy to acetaminophen and ibuprofen
- Allergy to gabapentin
- Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.
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 |
|---|---|---|
| Preoperative Gabapentin/Postoperative PlaceboPostoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain. | Drug | Preoperative Gabapentin/Postoperative Placebo |
| Preoperative Gabapentin/Postoperative GabapentinPostoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain. | Drug | Preoperative Gabapentin/Postoperative Gabapentin |
Primary outcome
Opioid Prescription at Discharge
Time frame: Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)
Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.
6 secondary outcomes
Opioid Refill Requests
Time frame: 6 weeks
Inpatient Pain Scores
Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)
Inpatient Morphine Milligram Equivalents
Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)
Length of Stay
Time frame: Time of registration for surgery to time of discharge from hospital
Nausea
Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)
Sedation
Time frame: On postoperative day 1 between 6AM and 10AM
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42294807Guanzon A, Hale D, Morse D, Bhamidipalli SS, Guise D, Hamner J, Heit M. Perioperative Gabapentin and Opioid Requirements: A Randomized Controlled Trial. Urogynecology (Phila). 2026 Jun 15. doi: 10.1097/SPV.0000000000001891. Online ahead of print.
- 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.
Douglass S Hale, MD 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 Preoperative Gabapentin/Postoperative Gabapentin in people with Postoperative Pain, 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?
The sponsor lists 5 inclusion and 4 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 23 Oct 2024. 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 23 Oct 2024). 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?
Opioid Prescription at Discharge (time frame: Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)). 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 NCT05494385, which also lists 1 linked publication.
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 23 Oct 2024.