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This study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.
The participants are randomized into two groups by computer randomization. The patient undergo spinal anesthesia with 0.5% Heavy bupivacaine with morphine 0.2 mg. IV PCA morphine is initiate in the post-anesthetic care unit. We compare post operative morphine consumption in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo in capsule is prescribed to the patient 60 min prior to the surgery. |
|
| Pregabalin | Active Comparator | Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Morphine Consumption | Cumulative morphine consumption in the first 24 hours is recorded from IV PCA | 6, 12, and 24 hours after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Analgesia | Time to first analgesia is recorded from IV PCA. | 24 hours |
| Pain Scores on the Visual Analog Scale | Pain score is evaluated by nurses using Numerical Rating Scale (NRS) Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taniga Kiatchai, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital | Bangkoknoi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24051389 | Background | Schmidt PC, Ruchelli G, Mackey SC, Carroll IR. Perioperative gabapentinoids: choice of agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 2013 Nov;119(5):1215-21. doi: 10.1097/ALN.0b013e3182a9a896. No abstract available. | |
| 21757554 | Background | Sahgal N, Banerjee A. Efficacy of pregabalin in acute postoperative pain: a meta-analysis. Br J Anaesth. 2011 Aug;107(2):274; author reply 275. doi: 10.1093/bja/aer207. No abstract available. |
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142 patients on gynecology unit during December 2014 - January 2016 were assessed for eligibility, 17 patient were not randomized due to didn't meet inclusion criteria (n=6), met exclusion criteria (n=4), declined to participate (n=7).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo in capsule is prescribed to the patient 60 min prior to the surgery. placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. |
| FG001 | Pregabalin | Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo in capsule is prescribed to the patient 60 min prior to the surgery. placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post Operative Morphine Consumption | Cumulative morphine consumption in the first 24 hours is recorded from IV PCA | Only 47 and 53 participants from placebo and pregabalin group, respectively, received IV-PCA morphine in the 1st 24 hours. The rest didn't require morphine consumption. | Posted | Median | Inter-Quartile Range | mg | 6, 12, and 24 hours after operation |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo in capsule is prescribed to the patient 60 min prior to the surgery. placebo: Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Taniga Kiatchai | Mahidol University | +66-2-419-7990 | taniga@gmail.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Pregabalin | Drug | Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. |
|
|
| 24 hours |
| Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability | Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire | 24 hours |
| Number of Patients Evaluating Their Satisfaction | Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied. | 24 hours |
| 21707548 | Background | Engelman E, Cateloy F. Efficacy and safety of perioperative pregabalin for post-operative pain: a meta-analysis of randomized-controlled trials. Acta Anaesthesiol Scand. 2011 Sep;55(8):927-43. doi: 10.1111/j.1399-6576.2011.02471.x. Epub 2011 Jun 27. |
| BG001 | Pregabalin | Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ASA physical status | ASA American Society of Anesthesiologists; ASA I - Healthy patient, ASA II - Patient with controlled systemic disease (higher ASA status means more complicated patient) | Count of Participants | Participants |
|
| OG001 | Pregabalin | Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. |
|
|
|
| Secondary | Time to First Analgesia | Time to first analgesia is recorded from IV PCA. | Only 47 and 53 participants from placebo and pregabalin group, respectively, received IV-PCA morphine in the 1st 24 hours. The rest didn't require morphine consumption. | Posted | Median | Inter-Quartile Range | hour | 24 hours |
|
|
|
|
| Secondary | Pain Scores on the Visual Analog Scale | Pain score is evaluated by nurses using Numerical Rating Scale (NRS) Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours |
|
|
|
|
| Secondary | Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability | Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire | Posted | Count of Participants | Participants | 24 hours |
|
|
|
|
| Secondary | Number of Patients Evaluating Their Satisfaction | Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Pregabalin | Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. | 0 | 62 | 0 | 62 | 0 | 62 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| 0.75 |
| Non-Inferiority |
alpha 0.05, beta 80% |
| Moderate |
|
| Severe |
|
| Nausea |
|
| Vomiting |
|
| Dizziness |
|
| Visual disturbance |
|
| 0.66 |
| Non-Inferiority |
Alpha 0.05, beta 80% |
| For Vomiting | Chi-squared | 0.46 | Non-Inferiority | alpha 0.05, beta 80% |
| For Dizziness | Chi-squared | 0.54 | Non-Inferiority | Alpha 0.05, beta 80% |
| For visual disturbance | Chi-squared | 0.05 | Non-Inferiority | Alpha 0.05, beta 80% |
| Moderate satisfied |
|
| Good satisfied |
|