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Pregabalin and Analgesia After Laparoscopic Cholecystectomy

Primary Purpose

Pain Postoperative

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Pregabalin

placebo

About this trial

This is an interventional supportive care trial for Pain Postoperative focused on measuring Pregabalin, Laparoscopic cholecystectomy, Postoperative pain, Opioid consumption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA physical status I-II

Exclusion Criteria:

Renal or hepatic insufficiency
Alcohol or drugs abuse
History of chronic pain or daily intake of analgesics
Uncontrolled medical disease (hypertension, diabetes) and cardiovascular problems. Psychiatric disorders
Inability of patients to use PCA pump
History of intake of non-steroidal anti-inflammatory drugs the last 24 hours before surgery,use of drainage after the surgery

Sites / Locations

University Hospital of Larissa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pregabalin

Placebo

Arm Description

Preoperative administration of pregabalin 600mg to patients undergo laparoscopic cholecystectomy.Patients receive oral Pregabalin 300 mg the night before the surgery, and another one dose of 300 mg 1 hour prior to surgery

Preoperative administration of placebo to patients undergo laparoscopic cholecystectomy.Patients receive oral Placebo the night before the surgery, and another one dose 1 hour prior to surgery.

Outcomes

Primary Outcome Measures

Postoperative pain

VAS = visual analoque scale 0-10 mm (0=no pain to 10= worst imaginable pain).Measured on the arrival of the patient to the recovery room(0 hrs), one hour later, and then every eight hours until the completion of 24 hours after operation.

Secondary Outcome Measures

Side- effects

To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, dizziness, blurred vision, lack of concentration, shoulder pain, sedation, and respiratory depression.

Postoperative opioid consumption

The total dose of morphine was calculated as mg and included opioids administered by PCA pump.On arrival in the PACU patients received morphine via PCA pump.Postoperative morphine requirements were assessed on the arrival of the patient to the recovery room (0 hrs), one hour later and then every eight hours, until the completion of 24 hours after operation.

Full Information

NCT ID

NCT01321801

First Posted

March 23, 2011

Last Updated

January 28, 2013

Sponsor

Larissa University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01321801

Brief Title

Pregabalin and Analgesia After Laparoscopic Cholecystectomy

Official Title

Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Larissa University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy.

Detailed Description

Acute pain frequently occurs during the postoperative period.Not treated acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of pregabalin, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that pregabalin may have a role in the post operative pain management, as an adjunct. Pregabalin is an anticonvulsant and anxiolytic drug, which have a more favorable pharmacokinetic profile from its predecessor gabapentin. Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.

6. Conditions and Keywords

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

Pain Postoperative

Keywords

Pregabalin, Laparoscopic cholecystectomy, Postoperative pain, Opioid consumption

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pregabalin

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Preoperative administration of placebo to patients undergo laparoscopic cholecystectomy.Patients receive oral Placebo the night before the surgery, and another one dose 1 hour prior to surgery.

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

Preoperative administration of pregabalin 600mg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Preoperative administration of a matching placebo

Primary Outcome Measure Information:

Title

Postoperative pain

Description

Time Frame

Every 8 hours

Secondary Outcome Measure Information:

Title

Side- effects

Description

Time Frame

0,1, 8, 16 & 24 hours

Title

Postoperative opioid consumption

Description

Time Frame

0,1, 8, 16 & 24 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA physical status I-II Exclusion Criteria: Renal or hepatic insufficiency Alcohol or drugs abuse History of chronic pain or daily intake of analgesics Uncontrolled medical disease (hypertension, diabetes) and cardiovascular problems. Psychiatric disorders Inability of patients to use PCA pump History of intake of non-steroidal anti-inflammatory drugs the last 24 hours before surgery,use of drainage after the surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chamaidi Sarakatsianou, RN, MSc

Organizational Affiliation