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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nalbuphine group; 0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal	Drug: Nalbuphine Hydrochloride 10 MG/ML; Nalbuphine(10mg/ml) 0.8 mg 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
Placebo Comparator: Control group; 0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Pain score	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.	12 hour postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total analgesics consumption	Total analgesics consumption in 24 hour postoperative	24 hour postoperative
Nausea and vomiting incidence	Incidence of adverse effect	24 hour postoperative
Pruritus incidence	Incidence of adverse effect	24 hour postoperative
VAS Pain score	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.	24 hour postoperative
Time to first rescue analgesia	The time from the intrathecal injection to the first analgesic intervention	24 hour postoperative
Sedation score(Ramsay sedation scale)	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.	24 hour postoperative

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Piyatida Pirasut, MD, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): November 28, 2024

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pain, Postoperative; Anesthesia, Spinal; Nalbuphine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Dermatologic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Antipruritics; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Bupivacaine; Acetaminophen; Ondansetron; Nalbuphine
• Other Study ID Numbers: 703/66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No