Postoperative Pain
Conditions
Keywords
Pregabalin, Laparoscopic colorectal surgery, Postoperative pain, Opioid consumption
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.
Interventions
DRUGPregabalin
Preoperative administration of pregabalin 300mg
DRUGPlacebo
Preoperative administration of placebo
DRUGMorphine
Postoperative administration of morphine via PCA pump for 48h
Sponsors
University of Thessaly
Larissa University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid consumption | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 48 hours | NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain) |
| Side- effects | 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 |
| Hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 1 week | — |
Countries
Greece
Outcome results
None listed