Comparison Between Dexamethasone and Morphine as an Adjuvant to Bupivacaine for Post-operative Analgesia
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|ClinicalTrials.gov Identifier: NCT03051022|
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lower Extremities Fracture||Drug: Dexamethasone 8 mg Drug: Morphine 2 mg||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Comparison Between Dexamethasone and Morphine as an Adjuvant to Epidural Bupivacaine for Post-operative Analgesia in Lower Extremity Surgery|
|Actual Study Start Date :||May 1, 2016|
|Actual Primary Completion Date :||November 30, 2016|
|Actual Study Completion Date :||March 31, 2017|
Active Comparator: Dexamethasone 8 mg
Bupivacaine 0,125% 12,5 mg combined with dexamethasone 8 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe.
Drug: Dexamethasone 8 mg
Dexamethasone 8 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.
Other Name: 0.9 % sodium chloride, 12.5 mg of 0.125% bupivacaine
Active Comparator: Morphine 2 mg
Bupivacaine 0,125% 12,5 mg combined with morphine 2 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe.
Drug: Morphine 2 mg
Morphine 2 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.
Other Name: 0.9% sodium chloride, 12.5 mg of 0.125% bupivacaine
- The degree of pain at 24-hours post-operative [ Time Frame: 24 hours post-operative ]The degree of pain was measured using Visual Analog Scale (VAS)
- The time for first requested post-operative additional analgesia [ Time Frame: 24 hours post-operative ]How long (in minutes) until the subject requested for an additional analgesics after surgery.
- The opioid requirement with the first 24-hours post-operative [ Time Frame: 24-hours post-operative ]Patient Controlled Analgesia (PCA) measured the opioid requirement in milligram.
- Side Effects [ Time Frame: 24-hours post-operative ]Side effects measured were incidences of nausea/vomiting, motoric inhibition, sedation, respiratory depression, hypotension
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051022
|Cipto Mangunkusumo Hospital|
|Central Jakarta, DKI Jakarta, Indonesia, 10430|
|Principal Investigator:||Aida R Tantri, PhD||Indonesia University|