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

NCT ID: NCT06153602

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-07

Study Completion Date

2024-11-28

Brief Summary

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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

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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.

Conditions

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Transurethral Resection of Prostate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nalbuphine group

0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal

Group Type EXPERIMENTAL

Nalbuphine Hydrochloride 10 MG/ML

Intervention Type DRUG

Nalbuphine(10mg/ml) 0.8 mg intrathecal

Bupivacaine Hydrochloride, Spinal

Intervention Type DRUG

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

Nalbuphine Hcl 10Mg/Ml Inj

Intervention Type DRUG

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

Acetaminophen 500Mg Tab

Intervention Type DRUG

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

Ondansetron 8mg

Intervention Type DRUG

8 mg IV prn for nausea or vomiting q 8 h

Control group

0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal

Group Type PLACEBO_COMPARATOR

Sodium Chloride 0.9 % in 5 ML Injection

Intervention Type DRUG

0.9% Sodium Chloride 0.08 ml intrathecal

Bupivacaine Hydrochloride, Spinal

Intervention Type DRUG

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

Nalbuphine Hcl 10Mg/Ml Inj

Intervention Type DRUG

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

Acetaminophen 500Mg Tab

Intervention Type DRUG

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

Ondansetron 8mg

Intervention Type DRUG

8 mg IV prn for nausea or vomiting q 8 h

Interventions

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Nalbuphine Hydrochloride 10 MG/ML

Nalbuphine(10mg/ml) 0.8 mg intrathecal

Intervention Type DRUG

Sodium Chloride 0.9 % in 5 ML Injection

0.9% Sodium Chloride 0.08 ml intrathecal

Intervention Type DRUG

Bupivacaine Hydrochloride, Spinal

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

Intervention Type DRUG

Nalbuphine Hcl 10Mg/Ml Inj

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

Intervention Type DRUG

Acetaminophen 500Mg Tab

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

Intervention Type DRUG

Ondansetron 8mg

8 mg IV prn for nausea or vomiting q 8 h

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Piyatida Pirasut, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Locations

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Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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703/66

Identifier Type: -

Identifier Source: org_study_id

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