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Completed

NCT Number: NCT06153602

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

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.

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Key information

Conditions

Transurethral Resection of Prostate Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nalbuphine Hydrochloride 10 MG/ML

Drug

Nalbuphine(10mg/ml) 0.8 mg intrathecal

Sodium Chloride 0.9 % in 5 ML Injection

Drug

0.9% Sodium Chloride 0.08 ml intrathecal

Bupivacaine Hydrochloride, Spinal

Drug

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

Nalbuphine Hcl 10Mg/Ml Inj

Drug

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

Acetaminophen 500Mg Tab

Drug

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

Ondansetron 8mg

Drug

8 mg IV prn for nausea or vomiting q 8 h

Primary outcomes

  1. 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.

Secondary outcomes

  1. VAS Pain score

    Time frame: 24 hour postoperative

    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.

  2. Time to first rescue analgesia

    Time frame: 24 hour postoperative

    The time from the intrathecal injection to the first analgesic intervention

  3. Total analgesics consumption

    Time frame: 24 hour postoperative

    Total analgesics consumption in 24 hour postoperative

  4. Nausea and vomiting incidence

    Time frame: 24 hour postoperative

    Incidence of adverse effect

  5. Pruritus incidence

    Time frame: 24 hour postoperative

    Incidence of adverse effect

  6. Sedation score(Ramsay sedation scale)

    Time frame: 24 hour postoperative

    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.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2023
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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