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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Pregabalin
Placebo
Morphine
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • University Hospital of Larissa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pregabalin & Morphine

Placebo & Morphine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative pain
NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)
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
Hospital stay

Full Information

First Posted
August 30, 2013
Last Updated
February 25, 2019
Sponsor
Larissa University Hospital
Collaborators
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT01940224
Brief Title
Evaluation of Preoperative Use of Pregabalin on Postoperative Analgesia After Laparoscopic Colorectal Surgery
Official Title
Effectiveness of Preemptive Use of Pregabalin on Pain Intensity and Postoperative Morphine Consumption After Laparoscopic Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larissa University Hospital
Collaborators
University of Thessaly

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Pregabalin, Laparoscopic colorectal surgery, Postoperative pain, Opioid consumption

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin & Morphine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo & Morphine
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
Preoperative administration of pregabalin 300mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Preoperative administration of placebo
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Postoperative administration of morphine via PCA pump for 48h
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)
Time Frame
48 hours
Title
Side- effects
Description
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
Time Frame
48 hours
Title
Hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Theodorou, MD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Tzovaras, MD, PhD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Georgia Stamatiou, MD, PhD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41100
Country
Greece

12. IPD Sharing Statement

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

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