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

Transurethral Resection of Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06153602
• Other study ID #: 703/66
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2023
• Source: Chulalongkorn University
• Contact: Piyatida Pirasut, MD
• Phone: (+66)2-2564000
• Email: piyatida.prs[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I-III

• Be candidates for regional anesthesia

Exclusion Criteria:

• Allergy to study medications or hypersensitive to local anesthetics

• Contraindicated for neuraxial anesthesia

• History of opioid abuse

• Cognitive impairment

Related Conditions & MeSH terms

• Transurethral Resection of Prostate

Intervention

Drug:
• Nalbuphine Hydrochloride 10 MG/ML
Nalbuphine(10mg/ml) 0.08 ml intrathecal
• Sodium Chloride 0.9 % in 5 ML Injection
0.9% Sodium Chloride 0.08 ml intrathecal

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Pain score	VAS pain score at motion 12 hour postoperative	12 hour postoperative
Secondary	VAS Pain score	VAS Pain score at rest and motion at immediate, 1, 6, 12, 24 hour postoperative	24 hour postoperative
Secondary	Time to first rescue analgesia	The time from the intrathecal injection to the first analgesic intervention (VAS score > 3)	24 hour postoperative
Secondary	Total analgesics consumption	Total analgesics consumption in 24 hour postoperative	24 hour postoperative
Secondary	Nausea and vomiting incidence	Incidence of adverse effect	24 hour postoperative
Secondary	Pruritus incidence	Incidence of adverse effect	24 hour postoperative
Secondary	Sedation score(Ramsay sedation scale)	Incidence of adverse effect	24 hour postoperative