Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
Postoperative pain is mediated by different mechanisms at multiple neural sites. Thus, multimodal analgesics can reduce the postoperative pain. Although Opioids are considered the analgesics of choice to treat moderate to severe pain, their use carries the risk of side effects and hyperalgesia. Multimodal analgesia can be achieved by combining different analgesics and different methods of administration, to provide better analgesia synergistically compared with conventional analgesia. Therefore,lower doses for each drug can be provided with fewer overall side-effects obtained from individual compounds. Recently, antidepressants such as duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), have accomplished pain relief in persistent and chronic pain as in fibromyalgia, postherpetic neuralgia, diabetic neuropathy, osteoarthritis and musculoskeletal pain. The analgesic effect of duloxetine is attributed to its ability to enhance both serotonin and norepinephrine neurotransmission in descending inhibitory pain pathways. Moreover, some studies have promoted its use to improve the quality of recovery after surgery and reduce the acute postoperative pain after knee replacement surgery , mastectomy , hysterectomy , and after spine surgery. In addition it can improve postoperative quality of recovery through mood improvement that can be helpful in the postoperative period. The main objective of the present study was to examine perioperativelythe analgesic efficacy with the combination of duloxetine and prgabalinon postoperative pain when given as part of a multimodal pain strategy in patients undergoing surgery on liosuction. In addition to evaluating the patient's satisfaction and the adverse effects related to the combination of both medications.

Official Title
-----------------
Effect of Combination of Duloxetine and Pregabalin to Improve Pain After Liposuction Surgery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Duloxetine and Pregabalin
* Drug: pregabalin
* Drug: sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients aged from 18 to40 years. ASA I-II. undergoing elective mega -liposuction surgery BMI from 18 to 50 kg/m2 2. Exclusion criteria: Patient refusal Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs ASA III-IV. Patients aged less than 18 or more than 40. Body mass index >50. Suffered from severe psychiatric disease or drug addiction; Chronic opioid consumption, a history of regular sedatives or anticonvulsants intake, serious organ disease or dysfunction inability to use a PCA device History of parenteral or oral analgesic intake within the last 48hours.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients in group I (PD group)<br> | Drug: Duloxetine and Pregabalin<br>* will be received pregabalin with duloxetine 90 minutes preoperatively, then pregabalin every 12 hours with duloxetine once daily postoperatively until the fifth postoperative day.<br>|
| Active Comparator: patients in group II (P group)<br> | Drug: pregabalin<br>* received pregabalin with a placebo capsule at 90 minutes preoperatively, then every 12 hours postoperatively with a placebo capsule once daily until the fifth postoperative day.<br>|
| Sham Comparator: patients in group III (C groups)<br> | Drug: sham<br>* received two placebo capsules at 90 minutes preoperatively then placebo capsules every 12 hours, with one capsule daily postoperatively until the fifth postoperative day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total morphine consumption by( mg ) over 5 day | Postoperative morphine consumption mg | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to 1st request of rescue analgesia. | Time to 1st request of rescue analgesia. | 24 hours | 
| Postoperative pain score | visual analog scale (VAS) score of pain (0 being 'no pain' and '10' being the maximal worst pain ) | 24 hous | 
| total intraoperative fentanyl consumption (microgram) during surgery | fentanyl used | 24 hous |