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

January 14, 2019 updated by: Mahidol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Morphine
0.5%Bupivacaine 2 ml with morphine 50 mcg for spinal anesthesia
Drug: Morphine
0.5%Hyperbaric bupivacaine 2 ml add morphine 50 mcg for spinal anesthesia
Other Names:
  • Hyperbaric bupivacaine with morphine
Placebo Comparator: Placebo
0.5%Bupivacaine 2 ml for spinal anesthesia
Drug: Placebo
0.5%Hyperbaric bupivacaine 2 ml for spinal anesthesia
Other Names:
  • Hyperbaric bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating scale (0-10)
Time Frame: 24 hours postoperatively
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
Time Frame: 24 hours postoperatively
requirement of pain control medication
24 hours postoperatively
Adverse effects
Time Frame: 24 hours postoperatively
incidence of side effects e.g. nausea and vomiting, itching and sedation
24 hours postoperatively
Satisfaction score
Time Frame: 24 hours postoperatively
Satisfaction score rated from 0-100
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Pawinee Pangthipampai, M.D., Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 1, 2015

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 019/2558(EC2)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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