Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy

September 28, 2017 updated by: Mohamed Said NAKHLI, Faculty of Medicine, Sousse

Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial

The aim of this study is to evaluate the effect of premedication with pregabalin or gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preoperative premedication with gabapentins reduces preoperative anxiety, stress response to surgical stimuli, decreases anesthetic use. The incidence of postoperative nausea and vomiting appears to be decreased. The other desired effect of gabapentins is the reduction in the intensity of postoperative pain after laparoscopic surgery.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Sousse, Tunisia, 4054
        • Sahloul Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • uncomplicated laparoscopic cholecystectomy
  • American Society of Anesthesiologists (ASA) status < 3

Exclusion Criteria:

  • acute cholecystitis
  • conversion to open cholecystectomy
  • history of epilepsia, psychiatric disorders and cognitive impairment
  • Pregnancy and breastfeeding
  • allergy to pregabalin and/or gabapentin
  • Chronic pain
  • Chronic medication by corticosteroids, neuroleptics or non steroidal anti inflammatory drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Patients receive 2 capsules as placebo 2 hours before anesthesia. The capsules are delivered by the hospital pharmacy.
Drug: Placebo oral capsule
In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.
Other Names:
  • placebo
Experimental: pregabalin
patients receive 2 capsules of pregabalin (pregabalin 75), two hours before anesthesia.
Drug: Pregabalin 75mg
In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.
Experimental: gabapentin
patients receive 2 capsules of gabapentin (gabapentin 300), two hours before anesthesia.
Drug: Gabapentin 300mg
In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative shoulder pain
Time Frame: VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery
Primary outcome is the intensity of shoulder pain during the first 48 hours after laparoscopic cholecystectomy using the visual analog scale (VAS).
VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
remifentanil consumption during anesthesia
Time Frame: one hour after tracheal tube removal
Remifentanil requirements during anesthesia were calculated (µg/kg/mn)
one hour after tracheal tube removal
Post operative sleep quality during the first night
Time Frame: first night after surgery
Patient's sleep quality was assessed during the first postoperative night by the Spiegel score.
first night after surgery
Post operative nausea and vomiting
Time Frame: 2, 6, 12, 24 and 48 hours after surgery.
The intensity of post operative nausea and vomiting was assessed by a 0 to 3 score (0: no nausea or vomiting, 1: slight mild nausea, 2: moderate nausea, 3: vomiting).
2, 6, 12, 24 and 48 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine, Sousse

Investigators

  • Principal Investigator: Mohamed Said Nakhli, MD, Faculty of Medicine, Sousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

August 30, 2017

Study Completion (Actual)

September 28, 2017

Study Registration Dates

First Submitted

July 29, 2017

First Submitted That Met QC Criteria

August 5, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nakhli anesthesia sahloul

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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