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

NCT03241875 | Completed Phase 4

• 1 other identifier: Nakhli anesthesia sahloul
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Cholecystectomy, Laparoscopic

Keywords

pregabalin; gabapentin; post operative pain; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• remifentanil consumption during anesthesia

  one hour after tracheal tube removal

• Post operative sleep quality during the first night

  first night after surgery

• Post operative nausea and vomiting

  2, 6, 12, 24 and 48 hours after surgery.

Study Arms (3)

placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

pregabalin

EXPERIMENTAL

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

Drug: Pregabalin 75mg

gabapentin

EXPERIMENTAL

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

Drug: Gabapentin 300mg

Interventions

Pregabalin 75mg DRUG

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

pregabalin

Gabapentin 300mg DRUG

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

gabapentin

Placebo oral capsule DRUG

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

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• uncomplicated laparoscopic cholecystectomy
• American Society of Anesthesiologists (ASA) status \< 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

Study Sites (1)

Sahloul Teaching Hospital

Sousse, 4054, Tunisia

Location

Related Publications (4)

• Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.

  PMID: 17513656 RESULT

• Valadan M, Banifatemi S, Yousefshahi F. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial. Anesth Pain Med. 2015 Dec 5;5(6):e31524. doi: 10.5812/aapm.31524. eCollection 2015 Dec.

  PMID: 26705527 RESULT

• Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.

  PMID: 18716003 RESULT

• Nakhli MS, Kahloul M, Jebali C, Frigui W, Naija W. Effects of Gabapentinoids Premedication on Shoulder Pain and Rehabilitation Quality after Laparoscopic Cholecystectomy: Pregabalin versus Gabapentin. Pain Res Manag. 2018 Jul 9;2018:9834059. doi: 10.1155/2018/9834059. eCollection 2018.

  PMID: 30123399 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin; Gabapentin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Amines; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mohamed Said Nakhli, MD

  Faculty of Medicine, Sousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, anesthesia and intensive care

Study Record Dates

• First Submitted: July 29, 2017
• First Posted: August 8, 2017
• Study Start: December 1, 2016
• Primary Completion: August 30, 2017
• Study Completion: September 28, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

TU (1)