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

• ClinicalTrials.gov Identifier: NCT01940224
• Recruitment Status: Completed
• First Posted: September 12, 2013
• Last Update Posted: February 27, 2019
• Sponsor: Larissa University Hospital
• Collaborator: University of Thessaly
• Information provided by (Responsible Party): Elena Theodorou, Larissa University Hospital

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

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: Pregabalin; Drug: Placebo; Drug: Morphine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of Preemptive Use of Pregabalin on Pain Intensity and Postoperative Morphine Consumption After Laparoscopic Colorectal Surgery
• Study Start Date: July 2013
• Actual Primary Completion Date: January 2018
• Actual Study Completion Date: January 2018

Arms and Interventions

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 Name: 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: Placebo; Preoperative administration of placebo; Drug: Morphine; Postoperative administration of morphine via PCA pump for 48h

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Postoperative pain [ Time Frame: 48 hours ]
   NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)
2. Side- effects [ Time Frame: 48 hours ]
   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
3. Hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Greece

University Hospital of Larissa

Larissa, Greece, 41100

Sponsors and Collaborators

Larissa University Hospital

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

More Information

• Responsible Party: Elena Theodorou, MD, Larissa University Hospital
• ClinicalTrials.gov Identifier: NCT01940224
• Other Study ID Numbers: UTH2828/26/06/2013
• First Posted: September 12, 2013
• Last Update Posted: February 27, 2019
• Last Verified: February 2019

Keywords provided by Elena Theodorou, Larissa University Hospital:

Pregabalin; Laparoscopic colorectal surgery; Postoperative pain; Opioid consumption

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Pregabalin; Morphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs