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

F

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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