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

Phase 4

Completed

• Conditions: Pain, Postoperative; Cholecystectomy, Laparoscopic
• Interventions: Drug: Placebo oral capsule; Drug: Pregabalin 75mg; Drug: Gabapentin 300mg

• Registration Number: NCT03241875
• Lead Sponsor: Faculty of Medicine, Sousse

Brief Summary

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.

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 Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-07-29
• Study First Submitted QC: 2017-08-05
• Study First Posted: 2017-08-08
• Primary Completion: 2017-08-30
• Status Verified: 2017-09
• Study Completion: 2017-09-28
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo oral capsule	Patients receive 2 capsules as placebo 2 hours before anesthesia. The capsules are delivered by the hospital pharmacy.
pregabalin	Pregabalin 75mg	patients receive 2 capsules of pregabalin (pregabalin 75), two hours before anesthesia.
gabapentin	Gabapentin 300mg	patients receive 2 capsules of gabapentin (gabapentin 300), two hours before anesthesia.

Primary Outcome Measures

Name	Time	Method
Post operative shoulder pain	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).

Secondary Outcome Measures

Name	Time	Method
remifentanil consumption during anesthesia	one hour after tracheal tube removal	Remifentanil requirements during anesthesia were calculated (µg/kg/mn)
Post operative sleep quality during the first night	first night after surgery	Patient's sleep quality was assessed during the first postoperative night by the Spiegel score.
Post operative nausea and vomiting	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).

Trial Locations

Locations (1)

Sahloul Teaching Hospital; 🇹🇳 Sousse, Tunisia