Pregabalin and Analgesia After Laparoscopic Cholecystectomy

Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01321801

Enrollment

Registered

2011-03-24

Start date

2009-11-30

Completion date

2010-12-31

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Postoperative

Keywords

Pregabalin, Laparoscopic cholecystectomy, Postoperative pain, Opioid consumption

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.

Interventions

DRUGPregabalin

Preoperative administration of pregabalin 600mg

DRUGplacebo

Preoperative administration of a matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain	Every 8 hours	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

Measure	Time frame	Description
Side- effects	0,1, 8, 16 & 24 hours	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	0,1, 8, 16 & 24 hour	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.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026