Effectiveness of Intrathecal Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in Patients Undergoing Transurethral Resection of the Prostate

Not Applicable

Not yet recruiting

• Conditions: Transurethral Resection of Prostate
• Interventions: Drug: Nalbuphine Hydrochloride 10 MG/ML; Drug: Sodium Chloride 0.9 % in 5 ML Injection

• Registration Number: NCT06153602
• Lead Sponsor: Chulalongkorn University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-11-23
• Last Update Submitted: 2023-11-23
• Study Start: 2023-11-27
• Study First Posted: 2023-12-01
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-10-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status I-III
• Be candidates for regional anesthesia

Read More

Exclusion Criteria

• Allergy to study medications or hypersensitive to local anesthetics
• Contraindicated for neuraxial anesthesia
• History of opioid abuse
• Cognitive impairment

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nalbuphine group	Nalbuphine Hydrochloride 10 MG/ML	0.5% Hyperbaric Spinal Bupivacaine 5-15 mg (1-3 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
Control group	Sodium Chloride 0.9 % in 5 ML Injection	0.5% Hyperbaric Spinal Bupivacaine 5-15 mg (1-3 ml) + 0.9% Sodium chloride 0.08 ml intrathecal

Primary Outcome Measures

Name	Time	Method
VAS Pain score	12 hour postoperative	VAS pain score at motion 12 hour postoperative

Secondary Outcome Measures

Name	Time	Method
Pruritus incidence	24 hour postoperative	Incidence of adverse effect
Total analgesics consumption	24 hour postoperative	Total analgesics consumption in 24 hour postoperative
Nausea and vomiting incidence	24 hour postoperative	Incidence of adverse effect
VAS Pain score	24 hour postoperative	VAS Pain score at rest and motion at immediate, 1, 6, 12, 24 hour postoperative
Time to first rescue analgesia	24 hour postoperative	The time from the intrathecal injection to the first analgesic intervention (VAS score \> 3)
Sedation score(Ramsay sedation scale)	24 hour postoperative	Incidence of adverse effect

Trial Locations

Locations (1)

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University; 🇹🇭 Pathum Wan, Bangkok, Thailand