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

Not Applicable

Completed

• Conditions: Spinal Anesthesia; Transurethral Resection of Prostate; Analgesia
• Interventions: Drug: Placebo; Drug: Morphine

• Registration Number: NCT02458742
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-29
• Study Start: 2015-06
• Study First Posted: 2015-06-01
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0.5%Bupivacaine 2 ml for spinal anesthesia
Morphine	Morphine	0.5%Bupivacaine 2 ml with morphine 50 mcg for spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Numerical rating scale (0-10)	24 hours postoperatively	Pain score rating by numerical rating scale in 24-hr postoperative

Secondary Outcome Measures

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