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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative, Cholecystectomy, Laparoscopic

Intervention / Treatment
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* Drug: Pregabalin 75mg
* Drug: Gabapentin 300mg
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative shoulder pain | 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 | Remifentanil requirements during anesthesia were calculated (µg/kg/mn) | one hour after tracheal tube removal | 
| Post operative sleep quality during the first night | Patient's sleep quality was assessed during the first postoperative night by the Spiegel score. | first night after surgery | 
| Post operative nausea and vomiting | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregabalin, gabapentin, post operative pain, laparoscopic cholecystectomy