Evaluation of Preoperative Use of Pregabalin on Postoperative Analgesia After Laparoscopic Colorectal Surgery

Effectiveness of Preemptive Use of Pregabalin on Pain Intensity and Postoperative Morphine Consumption After Laparoscopic Colorectal Surgery

The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 300mg, to attenuate postoperative pain and opioids consumption after laparoscopic colorectal surgery

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Pregabalin; Drug: Morphine; Drug: Placebo

Detailed Description

Laparoscopic colorectal surgery has gained wide acceptance because it is associated with reduced pain, lower morbidity, faster recovery and a shorter hospital stay. However, the optimal postoperative pain management method for patients undergoing laparoscopic colorectal surgery is still under evaluation and most of the recommendations are based on studies performed in open approach procedures.

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Larissa, Greece, 41100
    • University Hospital of Larissa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status I-III
• Patients who undergo laparoscopic colectomy for benign or malignant colorectal disease ( <Τ3 or =T3 tumors without distant metastasis )

Exclusion Criteria:

• Contraindication for pneumoperitoneum
• Contraindication for laparoscopic approach
• Renal or hepatic insufficiency
• Alcohol or drugs abuse
• History of chronic pain or daily intake of analgesics
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pregabalin & Morphine; Administration of pregabalin 300 mg to patients undergo laparoscopic colorectal surgery.Patients receive oral Pregabalin 150 mg the night before surgery, and another one dose of 150 mg 1 hour prior to surgery. Postoperative administration of morphine via PCA pump for 48 hours	Drug: Pregabalin; Preoperative administration of pregabalin 300mg; Other Names: Lyrica; Drug: Morphine; Postoperative administration of morphine via PCA pump for 48h
PLACEBO_COMPARATOR: Placebo & Morphine; Administration of placebo to patients undergo laparoscopic colorectal surgery.Patients receive oral Placebo the night before surgery, and another one dose 1 hour prior to surgery.Postoperative administration of morphine via PCA pump for 48 hours	Drug: Morphine; Postoperative administration of morphine via PCA pump for 48h; Drug: Placebo; Preoperative administration of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid consumption	The total dose of morphine was calculated as mg and administered by PCA pump. Postoperative morphine requirements were assessed on the arrival of the patient to the recovery room (0hrs),8 hrs,24 hrs until the completion of 48 hours after operation.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)	48 hours
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	48 hours
Hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 1 week

Collaborators and Investigators

• Sponsor: Larissa University Hospital
• Collaborators: University of Thessaly
• Investigators: Principal Investigator: Elena Theodorou, MD, University Hospital of Larissa; Study Chair: George Tzovaras, MD, PhD, University Hospital of Larissa; Study Director: Georgia Stamatiou, MD, PhD, University Hospital of Larissa

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: August 30, 2013
• First Submitted That Met QC Criteria: September 7, 2013
• First Posted (ESTIMATE): September 12, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pregabalin; Postoperative pain; Opioid consumption; Laparoscopic colorectal surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin; Morphine
• Other Study ID Numbers: UTH2828/26/06/2013