Spinal Morphine Provides an Effective Pain Control in Patients Undergoing Transurethral Resection of Prostate Gland

Study Overview
=================
Brief Summary
-----------------
Pain after transurethral resection of prostate is considered mild to moderate severity from detrusor muscle spasm and traction from urinary catheter. Numerous pain relieve methods have been studied including spinal opioids, spinal anesthesia with local anesthetic and dexmedetomidine, periprostatic nerve blockade with bupivacaine and mixing of prilocaine with distilled water irrigation while undergoing a procedure. Most of patients having this procedure are in elderly period, thus many anesthetists avoided spinal morphine which may cause respiratory depressant effect postoperatively. Although previous studies showed effectiveness of spinal morphine 25-200 mcg, some patients suffered from neuraxial opioid side effects. The aim of this study is to demonstrate efficacy of local anesthetic with intrathecal morphine 50 mcg providing pain relieve after transurethral resection of prostate compare to spinal anesthesia with sole local anesthetic.

Official Title
-----------------
Spinal Morphine (0.05 mg) Provides an Effective Pain Control in Patients Undergoing Transurethral Resection of Prostate Gland- a Randomized Double-blinded Control Trial

Conditions
-----------------
Spinal Anesthesia, Transurethral Resection of Prostate, Analgesia

Intervention / Treatment
-----------------
* Drug: Morphine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or = 18 years old Undergoing transurethral resection of prostate gland Exclusion Criteria: Contraindication for spinal anesthesia for any reasons eg. infection, bleeding disorder Refuse spinal anesthesia Allergic to study drugs History of cerebrovascular disease or stroke

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine<br>0.5%Bupivacaine 2 ml with morphine 50 mcg for spinal anesthesia | Drug: Morphine<br>* 0.5%Hyperbaric bupivacaine 2 ml add morphine 50 mcg for spinal anesthesia<br>* Other names: Hyperbaric bupivacaine with morphine;|
| Placebo Comparator: Placebo<br>0.5%Bupivacaine 2 ml for spinal anesthesia | Drug: Placebo<br>* 0.5%Hyperbaric bupivacaine 2 ml for spinal anesthesia<br>* Other names: Hyperbaric bupivacaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (0-10) | Pain score rating by numerical rating scale in 24-hr postoperative | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement of rescue pain | requirement of pain control medication | 24 hours postoperatively | 
| Adverse effects | incidence of side effects e.g. nausea and vomiting, itching and sedation | 24 hours postoperatively | 
| Satisfaction score | Satisfaction score rated from 0-100 | 24 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal anesthesia, intrathecal morphine, transurethral resection of prostate, postoperative pain