NCT06153602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

December 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2024

Completed
Last Updated

January 13, 2025

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

November 23, 2023

Last Update Submit

January 9, 2025

Conditions

Transurethral Resection of Prostate

Keywords

Anesthesia, SpinalPain, PostoperativeNalbuphine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • VAS Pain score

    24 hour postoperative

  • Time to first rescue analgesia

    24 hour postoperative

  • Total analgesics consumption

    24 hour postoperative

  • Nausea and vomiting incidence

    24 hour postoperative

  • Pruritus incidence

    24 hour postoperative

  • +1 more secondary outcomes

Study Arms (2)

Nalbuphine group

EXPERIMENTAL

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/MLDrug: Bupivacaine Hydrochloride, SpinalDrug: Nalbuphine Hcl 10Mg/Ml InjDrug: Acetaminophen 500Mg TabDrug: Ondansetron 8mg

Control group

PLACEBO COMPARATOR

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 InjectionDrug: Bupivacaine Hydrochloride, SpinalDrug: Nalbuphine Hcl 10Mg/Ml InjDrug: Acetaminophen 500Mg TabDrug: Ondansetron 8mg

Interventions

Nalbuphine Hydrochloride 10 MG/MLDRUG

Nalbuphine(10mg/ml) 0.8 mg intrathecal

Nalbuphine group
Sodium Chloride 0.9 % in 5 ML InjectionDRUG

0.9% Sodium Chloride 0.08 ml intrathecal

Control group
Bupivacaine Hydrochloride, SpinalDRUG

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

Control groupNalbuphine group
Nalbuphine Hcl 10Mg/Ml InjDRUG

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

Control groupNalbuphine group
Acetaminophen 500Mg TabDRUG

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

Control groupNalbuphine group
Ondansetron 8mgDRUG

8 mg IV prn for nausea or vomiting q 8 h

Control groupNalbuphine group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

NalbuphineSodium ChlorideInjectionsBupivacaineAcetaminophenOndansetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsDrug Administration RoutesDrug TherapyTherapeuticsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilidesImidazolesAzolesHeterocyclic Compounds, 1-RingCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Piyatida Pirasut, MD

    Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 1, 2023

Study Start

December 7, 2023

Primary Completion

November 27, 2024

Study Completion

November 28, 2024

Last Updated

January 13, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)