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

Faculty of Medicine, Sousse

Status and phase: Completed; Phase 4

Conditions: Cholecystectomy, Laparoscopic; Pain, Postoperative

Treatments: Drug: Pregabalin 75mg; Drug: Placebo oral capsule; Drug: Gabapentin 300mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03241875

Nakhli anesthesia sahloul

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Patients receive 2 capsules as placebo 2 hours before anesthesia. The capsules are delivered by the hospital pharmacy.

Treatment:

Drug: Placebo oral capsule

pregabalin

Experimental group

Description:

patients receive 2 capsules of pregabalin (pregabalin 75), two hours before anesthesia.

Treatment:

Drug: Pregabalin 75mg

gabapentin

Experimental group

Description:

patients receive 2 capsules of gabapentin (gabapentin 300), two hours before anesthesia.

Treatment:

Drug: Gabapentin 300mg