Effectiveness of Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in TURP Surgery
NCT ID: NCT06153602
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2023-12-07
2024-11-28
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nalbuphine group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
Nalbuphine Hydrochloride 10 MG/ML
Nalbuphine(10mg/ml) 0.8 mg intrathecal
Bupivacaine Hydrochloride, Spinal
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal
Nalbuphine Hcl 10Mg/Ml Inj
4 mg IV prn for postoperative pain score\>=4 q 6 h
Acetaminophen 500Mg Tab
1 tab oral prn for postoperative pain score 1-3 q 6 h
Ondansetron 8mg
8 mg IV prn for nausea or vomiting q 8 h
Control group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
Sodium Chloride 0.9 % in 5 ML Injection
0.9% Sodium Chloride 0.08 ml intrathecal
Bupivacaine Hydrochloride, Spinal
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal
Nalbuphine Hcl 10Mg/Ml Inj
4 mg IV prn for postoperative pain score\>=4 q 6 h
Acetaminophen 500Mg Tab
1 tab oral prn for postoperative pain score 1-3 q 6 h
Ondansetron 8mg
8 mg IV prn for nausea or vomiting q 8 h
Interventions
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Nalbuphine Hydrochloride 10 MG/ML
Nalbuphine(10mg/ml) 0.8 mg intrathecal
Sodium Chloride 0.9 % in 5 ML Injection
0.9% Sodium Chloride 0.08 ml intrathecal
Bupivacaine Hydrochloride, Spinal
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal
Nalbuphine Hcl 10Mg/Ml Inj
4 mg IV prn for postoperative pain score\>=4 q 6 h
Acetaminophen 500Mg Tab
1 tab oral prn for postoperative pain score 1-3 q 6 h
Ondansetron 8mg
8 mg IV prn for nausea or vomiting q 8 h
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria
* Contraindicated for neuraxial anesthesia
* Inability to self-report pain
* Chronic opioid used
18 Years
MALE
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Principal Investigators
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Piyatida Pirasut, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Locations
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Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University
Pathum Wan, Bangkok, Thailand
Countries
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Other Identifiers
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703/66
Identifier Type: -
Identifier Source: org_study_id
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