Transurethral Resection of ProstateNCT06153602

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

A study testing Nalbuphine Hydrochloride 10 MG/ML, Sodium Chloride 0.9 % in 5 ML Injection and Bupivacaine Hydrochloride, Spinal in people with Transurethral Resection of Prostate, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Transurethral Resection of Prostate
What is being tested?: Nalbuphine Hydrochloride 10 MG/ML, Sodium Chloride 0.9 % in 5 ML Injection and Bupivacaine Hydrochloride, Spinal
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteThailand
Study dates: 7 Dec 2023to 28 Nov 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

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

Other trials in Thailand

About this study

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

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.

Read the 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.

Conditions: Transurethral Resection of Prostate
Being tested: Nalbuphine Hydrochloride 10 MG/ML, Sodium Chloride 0.9 % in 5 ML Injection, Bupivacaine Hydrochloride, Spinal, Nalbuphine Hcl 10Mg/Ml Inj, Acetaminophen 500Mg Tab
Keywords: Anesthesia, Spinal, Pain, Postoperative, Nalbuphine
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nalbuphine Hydrochloride 10 MG/MLDrug
Nalbuphine(10mg/ml) 0.8 mg intrathecal
Sodium Chloride 0.9 % in 5 ML InjectionDrug
0.9% Sodium Chloride 0.08 ml intrathecal
Bupivacaine Hydrochloride, SpinalDrug
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal
Nalbuphine Hcl 10Mg/Ml InjDrug
4 mg IV prn for postoperative pain score>=4 q 6 h
Acetaminophen 500Mg TabDrug
1 tab oral prn for postoperative pain score 1-3 q 6 h
Ondansetron 8mgDrug
8 mg IV prn for nausea or vomiting q 8 h

Study groups in NCT06153602
Study group	Role	What they receive
Nalbuphine group	Experimental	0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal Receives: Drug: Nalbuphine Hydrochloride 10 MG/ML; Drug: Bupivacaine Hydrochloride, Spinal; Drug: Nalbuphine Hcl 10Mg/Ml Inj; Drug: Acetaminophen 500Mg Tab; Drug: 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 Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 hour postoperative

Secondary outcomes (6)

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.
Measured: 24 hour postoperative
Time to first rescue analgesia
The time from the intrathecal injection to the first analgesic intervention
Measured: 24 hour postoperative
Total analgesics consumption
Total analgesics consumption in 24 hour postoperative
Measured: 24 hour postoperative
Nausea and vomiting incidence
Incidence of adverse effect
Measured: 24 hour postoperative
Pruritus incidence
Incidence of adverse effect
Measured: 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.
Measured: 24 hour postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 202328 Nov 2024

First posted1 Dec 2023
Study start7 Dec 2023
Primary completion27 Nov 2024
Study completion28 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Transurethral Resection of ProstateStudies of the same condition, open and under way.
More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06153602
Sponsor's protocol ID: 703/66
Status last verified: Nov 2023
First submitted: 23 Nov 2023
Last updated: 13 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate
Mandala Coloring
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
RecruitingPhase 4
Tranexamic Acid for Bleeding Reduction During TURP Surgery
Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate
Recruiting
Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)
Transurethral Resection of Prostate Syndrome, Prostate Hyperplasia

All Transurethral Resection of Prostate trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Intrathecal Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in Patients Undergoing Transurethral Resection of the Prostate
ClinicalTrials.gov ID: NCT06153602
Acronym / sponsor ID: 703/66
Conditions: Transurethral Resection of Prostate
Keywords: Anesthesia, Spinal, Pain, Postoperative, Nalbuphine
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Chulalongkorn UniversityUniversity, hospital or other
Study start: 7 Dec 2023 (actual)
Primary completion: 27 Nov 2024 (actual)
Study completion: 28 Nov 2024 (actual)
First posted: 1 Dec 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nalbuphine group	Experimental	Drug: Nalbuphine Hydrochloride 10 MG/ML, Drug: Bupivacaine Hydrochloride, Spinal, Drug: Nalbuphine Hcl 10Mg/Ml Inj, Drug: Acetaminophen 500Mg Tab, Drug: Ondansetron 8mg0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
Control group	Placebo comparator	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 8mg0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nalbuphine Hydrochloride 10 MG/MLNalbuphine(10mg/ml) 0.8 mg intrathecal	Drug	Nalbuphine group
Sodium Chloride 0.9 % in 5 ML Injection0.9% Sodium Chloride 0.08 ml intrathecal	Drug	Control group
Bupivacaine Hydrochloride, Spinal0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal	Drug	Control group, Nalbuphine group
Nalbuphine Hcl 10Mg/Ml Inj4 mg IV prn for postoperative pain score>=4 q 6 h	Drug	Control group, Nalbuphine group
Acetaminophen 500Mg Tab1 tab oral prn for postoperative pain score 1-3 q 6 h	Drug	Control group, Nalbuphine group
Ondansetron 8mg8 mg IV prn for nausea or vomiting q 8 h	Drug	Control group, Nalbuphine group

Primary outcome

VAS Pain score
Time frame: 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.

6 secondary outcomes

VAS Pain score
Time frame: 24 hour postoperative
Time to first rescue analgesia
Time frame: 24 hour postoperative
Total analgesics consumption
Time frame: 24 hour postoperative
Nausea and vomiting incidence
Time frame: 24 hour postoperative
Pruritus incidence
Time frame: 24 hour postoperative
Sedation score(Ramsay sedation scale)
Time frame: 24 hour postoperative

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Transurethral Resection of Prostate

Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate
Mandala Coloring
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
RecruitingPhase 4
Tranexamic Acid for Bleeding Reduction During TURP Surgery
Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate
Recruiting
Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)
Transurethral Resection of Prostate Syndrome, Prostate Hyperplasia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Piyatida Pirasut, MD principal investigator

Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS Pain score (time frame: 12 hour postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06153602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.