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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940224
• Other study ID #: UTH2828/26/06/2013
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: January 2018

Study information

• Verified date: February 2019
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA physical status I-III

• Patients who undergo laparoscopic colectomy for benign or malignant colorectal disease ( <?3 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Pregabalin
Preoperative administration of pregabalin 300mg
• Placebo
Preoperative administration of placebo
• Morphine
Postoperative administration of morphine via PCA pump for 48h

Locations

Country	Name	City	State
Greece	University Hospital of Larissa	Larissa

Sponsors (2)

Lead Sponsor	Collaborator
Larissa University Hospital	University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

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