Effectiveness of Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in TURP Surgery

NCT06153602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-01-13

No results posted yet for this study

Summary

The goal of this clinical trial is to compare pain after surgery in patients undergoing Transurethral Resection of Prostate. The main question it aims to answer are: Intrathecal nalbuphine as an adjuvant to local anesthetic will better provide pain relief after TURP surgery.

Participants will be given a combination of nalbuphine and local anesthetic when getting a spinal block. Researchers will compare control group, given look-alike solution that contains no active drug to see if nalbuphine will better provide pain relief after surgery.

Conditions

  • Transurethral Resection of Prostate

Interventions

DRUG

Nalbuphine Hydrochloride 10 MG/ML

Nalbuphine(10mg/ml) 0.8 mg intrathecal

DRUG

Sodium Chloride 0.9 % in 5 ML Injection

0.9% Sodium Chloride 0.08 ml intrathecal

DRUG

Bupivacaine Hydrochloride, Spinal

0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal

DRUG

Nalbuphine Hcl 10Mg/Ml Inj

4 mg IV prn for postoperative pain score\>=4 q 6 h

DRUG

Acetaminophen 500Mg Tab

1 tab oral prn for postoperative pain score 1-3 q 6 h

DRUG

Ondansetron 8mg

8 mg IV prn for nausea or vomiting q 8 h

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Piyatida Pirasut, MD · Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2024-11-27
Completion
2024-11-28

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06153602 on ClinicalTrials.gov