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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nalbuphine group | Experimental | 0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal |
|
| Control group | Placebo Comparator | 0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine Hydrochloride 10 MG/ML | Drug | Nalbuphine(10mg/ml) 0.8 mg intrathecal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 hour postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hour postoperative |
| Time to first rescue analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piyatida Pirasut, MD | Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University | Pathum Wan | Bangkok | 10330 | Thailand |
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| Sodium Chloride 0.9 % in 5 ML Injection |
| Drug |
0.9% Sodium Chloride 0.08 ml intrathecal |
|
| Bupivacaine Hydrochloride, Spinal | Drug | 0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal |
|
| Nalbuphine Hcl 10Mg/Ml Inj | Drug | 4 mg IV prn for postoperative pain score>=4 q 6 h |
|
| Acetaminophen 500Mg Tab | Drug | 1 tab oral prn for postoperative pain score 1-3 q 6 h |
|
| Ondansetron 8mg | Drug | 8 mg IV prn for nausea or vomiting q 8 h |
|
The time from the intrathecal injection to the first analgesic intervention |
| 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) | 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. | 24 hour postoperative |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| D012965 | Sodium Chloride |
| D007267 | Injections |
| D002045 | Bupivacaine |
| D000082 | Acetaminophen |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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