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

Not Applicable

Completed

• Conditions: Transurethral Resection of Prostate
• Interventions: Drug: Nalbuphine Hydrochloride 10 MG/ML; Drug: Sodium Chloride 0.9 % in 5 ML Injection; Drug: Bupivacaine Hydrochloride, Spinal; Drug: Nalbuphine Hcl 10Mg/Ml Inj; Drug: Acetaminophen 500Mg Tab; Drug: Ondansetron 8mg

• 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

This study aims to evaluate the efficacy and side effects of nalbuphine, with the goal of providing anesthesiologists with evidence-based guidance for selecting the most appropriate pharmacological agents for their patients.

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-11-23
• Study First Posted: 2023-12-01
• Study Start: 2023-12-07
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-28
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

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

Inclusion Criteria

• Patients scheduled for Transurethral Resection of Prostate under spinal anesthesia
• American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria

• Allergy to study medications or hypersensitive to local anesthetics
• Contraindicated for neuraxial anesthesia
• Inability to self-report pain
• Chronic opioid used

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nalbuphine group	Nalbuphine Hydrochloride 10 MG/ML	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
Nalbuphine group	Bupivacaine Hydrochloride, Spinal	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
Control group	Bupivacaine Hydrochloride, Spinal	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
Control group	Nalbuphine Hcl 10Mg/Ml Inj	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
Nalbuphine group	Nalbuphine Hcl 10Mg/Ml Inj	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
Nalbuphine group	Acetaminophen 500Mg Tab	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
Nalbuphine group	Ondansetron 8mg	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
Control group	Sodium Chloride 0.9 % in 5 ML Injection	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
Control group	Acetaminophen 500Mg Tab	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
Control group	Ondansetron 8mg	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal

Primary Outcome Measures

Name	Time	Method
VAS Pain score	12 hour postoperative	Pain score during motion 12 hours postoperatively was assessed using a standard 10 cm linear Visual Analogue Scale, where 0 represents the minimum score and 10 the maximum, with higher scores indicating worse outcomes.

Secondary Outcome Measures

Name	Time	Method
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 postoperatively was assessed using a standard 10 cm linear Visual Analogue Scale, where 0 represents the minimum score and 10 the maximum, with higher scores indicating worse outcomes.
Time to first rescue analgesia	24 hour postoperative	The time from the intrathecal injection to the first analgesic intervention
Total analgesics consumption	24 hour postoperative	Total analgesics consumption in 24 hour postoperative
Pruritus incidence	24 hour postoperative	Incidence of adverse effect
Sedation score(Ramsay sedation scale)	24 hour postoperative	Sedation was assessed using the Ramsay Sedation Scale, which grades sedation on a scale from 1 to 6 based on the patient's responsiveness to stimuli, higher scores generally indicate deeper sedation.

Trial Locations

Locations (1)

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