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OpenTrials
Completed

NCT Number: NCT02458742

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

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.

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Key information

Conditions

Spinal Anesthesia Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Transurethral Resection of Prostate

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

0.5%Hyperbaric bupivacaine 2 ml add morphine 50 mcg for spinal anesthesia

Other names: Hyperbaric bupivacaine with morphine

Placebo

Drug

0.5%Hyperbaric bupivacaine 2 ml for spinal anesthesia

Other names: Hyperbaric bupivacaine

Primary outcomes

  1. Numerical rating scale (0-10)

    Time frame: 24 hours postoperatively

    Pain score rating by numerical rating scale in 24-hr postoperative

Secondary outcomes

  1. Requirement of rescue pain

    Time frame: 24 hours postoperatively

    requirement of pain control medication

  2. Adverse effects

    Time frame: 24 hours postoperatively

    incidence of side effects e.g. nausea and vomiting, itching and sedation

  3. Satisfaction score

    Time frame: 24 hours postoperatively

    Satisfaction score rated from 0-100

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2015
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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