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

Primary Purpose

Pain, Postoperative, Cholecystectomy, Laparoscopic

Status

Completed

Phase

Phase 4

Locations

Tunisia

Study Type

Interventional

Intervention

Pregabalin 75mg

Gabapentin 300mg

Placebo oral capsule

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring pregabalin, gabapentin, post operative pain, laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sahloul Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

pregabalin

gabapentin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

remifentanil consumption during anesthesia

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

Post operative sleep quality during the first night

Patient's sleep quality was assessed during the first postoperative night by the Spiegel score.

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).

Full Information

NCT ID

NCT03241875

First Posted

July 29, 2017

Last Updated

September 28, 2017

Sponsor

Faculty of Medicine, Sousse

1. Study Identification

Unique Protocol Identification Number

NCT03241875

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

August 30, 2017 (Actual)

Study Completion Date

September 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Faculty of Medicine, Sousse

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Cholecystectomy, Laparoscopic

Keywords

pregabalin, gabapentin, post operative pain, laparoscopic cholecystectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

pregabalin

Arm Type

Experimental

Arm Description

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

Arm Title

gabapentin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pregabalin 75mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gabapentin 300mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Other Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Post operative shoulder pain

Description

Primary outcome is the intensity of shoulder pain during the first 48 hours after laparoscopic cholecystectomy using the visual analog scale (VAS).

Time Frame

VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery

Secondary Outcome Measure Information:

Title

remifentanil consumption during anesthesia

Description

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

Time Frame

one hour after tracheal tube removal

Title

Post operative sleep quality during the first night

Description

Patient's sleep quality was assessed during the first postoperative night by the Spiegel score.

Time Frame

first night after surgery

Title

Post operative nausea and vomiting

Description

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).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Said Nakhli, MD

Organizational Affiliation

Faculty of Medicine, Sousse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sahloul Teaching Hospital

City

Sousse

ZIP/Postal Code

4054

Country

Tunisia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

17513656

Citation

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.

Results Reference

result

PubMed Identifier

26705527

Citation

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.

Results Reference

result

PubMed Identifier

18716003

Citation

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.

Results Reference

result

PubMed Identifier

30123399

Citation

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.

Results Reference

derived

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

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