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

Postoperative Pain research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postoperative Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PregabalinPreoperative administration of pregabalin 300mg

Drug:PlaceboPreoperative administration of placebo

Drug:MorphinePostoperative administration of morphine via PCA pump for 48h

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Recruiting

Start Date: July 2013

Completed Date: September 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Postoperative opioid consumption

Secondary Outcome: Postoperative pain

Study sponsors, principal investigator, and references

Principal Investigator: Elena Theodorou, MD

Lead Sponsor: Larissa University Hospital

Collaborator: University of Thessaly

More information:https://clinicaltrials.gov/show/NCT01940224

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