Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.

Detailed Description
-----------------
The participants are randomized into two groups by computer randomization. The patient undergo spinal anesthesia with 0.5% Heavy bupivacaine with morphine 0.2 mg. IV PCA morphine is initiate in the post-anesthetic care unit. We compare post operative morphine consumption in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.

Official Title
-----------------
Effects of Pre-operative Oral Pregabalin on Post Operative Morphine Consumption After Abdominal Hysterectomy With/Without Salpingo-oophorectomy Under Spinal Anesthesia With Intrathecal Morphine

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine Patient can use patient-controlled analgesia (IV PCA) Exclusion Criteria: History of drug allergy to gabapentinoid and related drug History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and Psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo in capsule is prescribed to the patient 60 min prior to the surgery. | Drug: placebo<br>* Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.<br>|
| Active Comparator: Pregabalin<br>Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. | Drug: Pregabalin<br>* Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.<br>* Other names: Lyrica;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Morphine Consumption | Cumulative morphine consumption in the first 24 hours is recorded from IV PCA | 6, 12, and 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Analgesia | Time to first analgesia is recorded from IV PCA. | 24 hours | 
| Pain Scores on the Visual Analog Scale | Pain score is evaluated by nurses using Numerical Rating Scale (NRS) Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome | 24 hours | 
| Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability | Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire | 24 hours | 
| Number of Patients Evaluating Their Satisfaction | Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregabalin, postoperative pain, abdominal hysterectomy