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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02458742
Enrollment
80
Registered
2015-06-01
Start date
2015-06-30
Completion date
2016-09-30
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Spinal Anesthesia, Transurethral Resection of Prostate

Keywords

spinal anesthesia, intrathecal morphine, transurethral resection of prostate, postoperative pain

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.

Interventions

DRUGMorphine

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

DRUGPlacebo

0.5%Hyperbaric bupivacaine 2 ml for spinal anesthesia

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Numerical rating scale (0-10)24 hours postoperativelyPain score rating by numerical rating scale in 24-hr postoperative

Secondary

MeasureTime frameDescription
Requirement of rescue pain24 hours postoperativelyrequirement of pain control medication
Adverse effects24 hours postoperativelyincidence of side effects e.g. nausea and vomiting, itching and sedation
Satisfaction score24 hours postoperativelySatisfaction score rated from 0-100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026