Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management

NCT02703259 | Completed Phase 4 Results

• 1 other identifier: 603262
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the investigators' study is to assess the efficacy of a single dose of preoperative gabapentin within an enhanced recovery after surgery protocol in acute postoperative pain reduction for women undergoing a minimally invasive hysterectomy. Participants who consent to participate will be randomized to either a control group without gabapentin or to a study arm and receive gabapentin 600 mg prior to their planned surgery. The investigators will collect data on postoperative narcotic use, subjective pain as rated by a numeric pain scale, in addition to any adverse effects of single dose gabapentin use.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• Narcotic Use at 24 Hours Postop

  Assessment of the amount of narcotic use postoperatively at 24 hours. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents

  24 hours

• Subjective Pain at 24 Hours Postoperative

  Pain score assesses patient subjective pain via patient reported numeric analogue scale, range 0-10 with 0 being no pain and 10 being severe pain.

  24 hours

Secondary Outcomes (4)

• Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively

  24 hours

• Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively

  2 weeks

• Narcotic Use at 2 Weeks Postop

  2 weeks

• Subjective Pain at 2 Weeks Postop

  2 weeks

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include: Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules

Drug: Gabapentin; Drug: Acetaminophen; Drug: Celecoxib

Control

PLACEBO COMPARATOR

As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include: Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules

Drug: Acetaminophen; Drug: Celecoxib

Interventions

Gabapentin DRUG

Gabapentin

Acetaminophen DRUG

Control; Gabapentin

Celecoxib DRUG

Control; Gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing a minimally invasive hysterectomy with surgeons operating within the Christiana Care Health System at the Newark location only.
• at least 18 years of age
• able to swallow tablets or capsules

You may not qualify if:

• liver failure
• renal failure
• prior gastric bypass
• gastroparesis
• recent or current regular gabapentin use
• hypersensitivity to gabapentin, acetominophen, or celecoxib
• procedure is converted to laparotomy for any indication. (Mini-laparotomy for specimen removal alone will not be excluded.)

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

Related Publications (7)

• Alayed N, Alghanaim N, Tan X, Tulandi T. Preemptive use of gabapentin in abdominal hysterectomy: a systematic review and meta-analysis. Obstet Gynecol. 2014 Jun;123(6):1221-1229. doi: 10.1097/AOG.0000000000000289.

  PMID: 24807337 BACKGROUND

• Clarke H, Bonin RP, Orser BA, Englesakis M, Wijeysundera DN, Katz J. The prevention of chronic postsurgical pain using gabapentin and pregabalin: a combined systematic review and meta-analysis. Anesth Analg. 2012 Aug;115(2):428-42. doi: 10.1213/ANE.0b013e318249d36e. Epub 2012 Mar 13.

  PMID: 22415535 BACKGROUND

• Dolin SJ, Cashman JN. Tolerability of acute postoperative pain management: nausea, vomiting, sedation, pruritus, and urinary retention. Evidence from published data. Br J Anaesth. 2005 Nov;95(5):584-91. doi: 10.1093/bja/aei227. Epub 2005 Sep 16.

  PMID: 16169893 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

• Straube S, Derry S, Moore RA, Wiffen PJ, McQuay HJ. Single dose oral gabapentin for established acute postoperative pain in adults. Cochrane Database Syst Rev. 2010 May 12;2010(5):CD008183. doi: 10.1002/14651858.CD008183.pub2.

  PMID: 20464764 BACKGROUND

• Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.

  PMID: 17513656 BACKGROUND

• 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.

  PMID: 32389735 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin; Acetaminophen; Celecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

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; Acetanilides; Anilides; Amides; Aniline Compounds; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Study limited by recall bias and imperfect patient blinding inherent in placebo equivalent methadology. Most patients discharged prior to 24 hours, therefore data collected dependent on patient reporting.

Results Point of Contact

• Title: Dr. Terri Huynh
• Organization: Christiana Care Health Systems

terri.huynh@christianacare.org

302-623-4410

Study Officials

• Terri Huynh, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

• Gretchen Makai, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 9, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 20, 2020
• Results First Posted: February 15, 2019

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)