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Clinical Trials/NCT01940224
NCT01940224
Completed
Not Applicable

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

Larissa University Hospital1 site in 1 country50 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Pregabalin
Conditions
Postoperative Pain
Sponsor
Larissa University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Postoperative opioid consumption
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
January 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Larissa University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Elena Theodorou

MD

Larissa University Hospital

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Pregabalin

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

Intervention: Morphine

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

Intervention: Placebo

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

Intervention: Morphine

Outcomes

Primary Outcomes

Postoperative opioid consumption

Time Frame: 48 hours

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.

Secondary Outcomes

  • Postoperative pain(48 hours)
  • Side- effects(48 hours)
  • Hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 1 week)

Study Sites (1)

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