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
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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