Transurethral Resection of Prostate
Conditions
Keywords
Anesthesia, Spinal, Pain, Postoperative, Nalbuphine
Brief 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.
Detailed 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.
Interventions
Nalbuphine(10mg/ml) 0.8 mg intrathecal
DRUGSodium Chloride 0.9 % in 5 ML Injection
0.9% Sodium Chloride 0.08 ml intrathecal
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal
DRUGNalbuphine Hcl 10Mg/Ml Inj
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
DRUGOndansetron 8mg
8 mg IV prn for nausea or vomiting q 8 h
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Pain score | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to first rescue analgesia | 24 hour postoperative | The time from the intrathecal injection to the first analgesic intervention |
| Total analgesics consumption | 24 hour postoperative | Total analgesics consumption in 24 hour postoperative |
| VAS Pain score | 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. |
| Pruritus incidence | 24 hour postoperative | Incidence of adverse effect |
| Sedation score(Ramsay sedation scale) | 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. |
| Nausea and vomiting incidence | 24 hour postoperative | Incidence of adverse effect |
Countries
Thailand
Outcome results
None listed