Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion

NCT03151746 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STU00205047
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study's objective is to determine the efficacy of preoperative gabapentin in relieving postoperative pain, reducing opioid use and improving quality of recovery in subjects undergoing urologic surgery. Investigators hypothesize that subjects receiving gabapentin will have lower pain scores, less opioid consumption and better quality of recovery as compared to subjects who are given a placebo.

Conditions

Anesthesia; Urethral Obstruction

Outcome Measures

Primary Outcomes (1)

• 48 Hours Morphine Equivalents Consumed.

  Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.

  Up to 48 hours after surgery

Secondary Outcomes (2)

• 24 Hour Pain Burden

  24 hours after surgery

• QOR 40 Questionnaire Scores

  48 hours after surgical procedure

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo pill administered 1 hour before planned surgical procedure

Drug: Placebo

Gabapentin

EXPERIMENTAL

Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure

Drug: Gabapentin

Interventions

Placebo DRUG

Placebo pill administered orally 1 hour before planned surgical procedure

Placebo

Gabapentin DRUG

Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure

Gabapentin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years to 75 years
• Patients with obstructive kidney stones undergoing elective ureteroscopy or cystoscopy with Ureteral stent placement

You may not qualify if:

• Age less than 18 or more than 75 years
• Acetaminophen allergy
• Gabapentin allergy
• Hydromorphone allergy
• Chronic use of gabapentin
• History of chronic pain (Pain for \> than 3 months)
• Chronic renal insufficiency (Creatinine \> 1.3)
• Seizure disorder
• Psychiatric disorders (medically treated)
• Chronic use of anticonvulsants, antidepressants, antipsychotics (use \> 3 months)
• Antacids ingested within 2 hours prior to surgery
• History of gastric or duodenal ulcer
• Pregnant or lactating
• Inability to communicate in English

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003 Mar;169(3):1065-9; discussion 1069. doi: 10.1097/01.ju.0000048980.33855.90.

  PMID: 12576847 BACKGROUND

• Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23.

  PMID: 27125392 BACKGROUND

• Schmidt PC, Ruchelli G, Mackey SC, Carroll IR. Perioperative gabapentinoids: choice of agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 2013 Nov;119(5):1215-21. doi: 10.1097/ALN.0b013e3182a9a896. No abstract available.

  PMID: 24051389 BACKGROUND

• Mason CJ. High frequency jet ventilation through a Robertshaw double lumen tube. Anaesthesia. 1986 Mar;41(3):330. doi: 10.1111/j.1365-2044.1986.tb12811.x. No abstract available.

  PMID: 3963344 BACKGROUND

• Bala I, Bharti N, Chaubey VK, Mandal AK. Efficacy of gabapentin for prevention of postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor. Urology. 2012 Apr;79(4):853-7. doi: 10.1016/j.urology.2011.11.050. Epub 2012 Feb 4.

  PMID: 22309784 BACKGROUND

MeSH Terms

Conditions

Urethral Obstruction

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The limitation to this study is that enrollment was affected by COVID 19 protocols within the hospital enrollment. This is why the project was terminated early .

Results Point of Contact

• Title: Paul Fitzgerald
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• Luminita Tureanu, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded by using placebo or active drug supplied by Investigational Drug Pharmacy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double Blind, Randomized, Placebo Controlled Trial

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 12, 2017
• Study Start: January 14, 2018
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: July 21, 2022
• Results First Posted: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)