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

Chulalongkorn University

Status: Completed

Conditions: Transurethral Resection of Prostate

Treatments: Drug: Bupivacaine Hydrochloride, Spinal; Drug: Sodium Chloride 0.9 % in 5 ML Injection; Drug: Nalbuphine Hcl 10Mg/Ml Inj; Drug: Ondansetron 8mg; Drug: Nalbuphine Hydrochloride 10 MG/ML; Drug: Acetaminophen 500Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT06153602

703/66

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 80 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Nalbuphine group

Experimental group

Description:

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

Treatment:

Drug: Acetaminophen 500Mg Tab

Drug: Nalbuphine Hydrochloride 10 MG/ML

Drug: Ondansetron 8mg

Drug: Nalbuphine Hcl 10Mg/Ml Inj

Drug: Bupivacaine Hydrochloride, Spinal

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Acetaminophen 500Mg Tab

Drug: Ondansetron 8mg

Drug: Nalbuphine Hcl 10Mg/Ml Inj

Drug: Sodium Chloride 0.9 % in 5 ML Injection

Drug: Bupivacaine Hydrochloride, Spinal