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Pregabalin and Analgesia After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chamaidi Sarakatsianou, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01321801
First received: March 23, 2011
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Pain Postoperative
 Drug: Pregabalin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy

Resource links provided by NLM:

Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: Every 8 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0,1, 8, 16 & 24 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0,1, 8, 16 & 24 hour ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pregabalin
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
 Drug: Pregabalin
Preoperative administration of pregabalin 600mg
Other Name: Lyrica
Placebo Comparator: Placebo
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.
 Drug: placebo
Preoperative administration of a matching placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321801

Locations
Greece
University Hospital of Larissa
Larissa, Greece, 41100
Sponsors and Collaborators
Larissa University Hospital
Investigators
Principal Investigator: Chamaidi Sarakatsianou, RN, MSc University Hospital of Larissa
Study Chair: George Tzovaras, MD University Hospital of Larissa
Study Director: Georgia Stamatiou, MD University Hospital of Larissa
Study Chair: Elena Theodorou, MD University Hospital of Larissa
Study Chair: Stavroula Georgopoulou, MD University Hospital of Larissa
  More Information

Publications:

Responsible Party: Chamaidi Sarakatsianou, RN,MSc, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01321801     History of Changes
Other Study ID Numbers: UHL25872/ 08/17/09
Study First Received: March 23, 2011
Last Updated: January 28, 2013
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Larissa University Hospital:
Pregabalin
Laparoscopic cholecystectomy
Postoperative pain
Opioid consumption

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pregabalin
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013