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NCT Number: NCT03241875

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

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.

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Key information

Conditions

Pain, Postoperative Cholecystectomy, Laparoscopic Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sahloul Teaching Hospital

Sousse, 4054, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin 75mg

Drug

In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.

Gabapentin 300mg

Drug

In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.

Placebo oral capsule

Drug

In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.

Other names: placebo

Primary outcomes

  1. 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).

Secondary outcomes

  1. remifentanil consumption during anesthesia

    Time frame: one hour after tracheal tube removal

    Remifentanil requirements during anesthesia were calculated (µg/kg/mn)

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Faculty of Medicine, Sousse

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2017
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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