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

Study Overview
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Brief Summary
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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.

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

Conditions
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Transurethral Resection of Prostate

Intervention / Treatment
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* Drug: Nalbuphine Hydrochloride 10 MG/ML
* Drug: Sodium Chloride 0.9 % in 5 ML Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nalbuphine group<br>0.5% Hyperbaric Spinal Bupivacaine 5-15 mg (1-3 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal | Drug: Nalbuphine Hydrochloride 10 MG/ML<br>* Nalbuphine(10mg/ml) 0.08 ml intrathecal<br>|
| Placebo Comparator: Control group<br>0.5% Hyperbaric Spinal Bupivacaine 5-15 mg (1-3 ml) + 0.9% Sodium chloride 0.08 ml intrathecal | Drug: Sodium Chloride 0.9 % in 5 ML Injection<br>* 0.9% Sodium Chloride 0.08 ml intrathecal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Pain score | VAS pain score at motion 12 hour postoperative | 12 hour postoperative | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Spinal, Pain, Postoperative, Nalbuphine