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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Nalbuphine(10mg/ml) 0.8 mg intrathecal
0.9% Sodium Chloride 0.08 ml intrathecal
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal
4 mg IV prn for postoperative pain score\>=4 q 6 h
1 tab oral prn for postoperative pain score 1-3 q 6 h
8 mg IV prn for nausea or vomiting q 8 h
Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University
Pathum Wan, Bangkok, Thailand
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.
Time frame: 12 hour postoperative
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.
Time frame: 24 hour postoperative
Time to first rescue analgesia
The time from the intrathecal injection to the first analgesic intervention
Time frame: 24 hour postoperative
Total analgesics consumption
Total analgesics consumption in 24 hour postoperative
Time frame: 24 hour postoperative
Nausea and vomiting incidence
Incidence of adverse effect
Time frame: 24 hour postoperative
Pruritus incidence
Incidence of adverse effect
Time frame: 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.
Time frame: 24 hour postoperative
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