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
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Condition or disease | Intervention/treatment | Phase |
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Lower Extremities Fracture | Drug: Dexamethasone 8 mg Drug: Morphine 2 mg | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
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 |

Arm | Intervention/treatment |
---|---|
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.
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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.
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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

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects aged 18-60 years old with American Society of Anesthesiologists (ASA) physical status I-II and body mass index (BMI) 18,5-25 kg/m2 who were planned to undergo lower extremity surgery
- Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form
Exclusion Criteria:
- Subjects with history of bupivacaine allergy
- Subjects with history of morphine allergy
- Subjects with history of urine retention
- Subjects with history of gait disturbance or using prosthetic, Subjects with history of peptic ulcer
- Subjects with history of long term use of corticosteroid
- Subjects with contraindications for epidural anesthesia
- Subjects rejected to participate in the study.
Drop out criteria:
- Subjects with epidural anesthesia complications (e.g. shock, anaphylactic reaction, seizures, severe respiratory disturbance)
- Subjects with failed epidural anesthesia.

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
Indonesia | |
Cipto Mangunkusumo Hospital | |
Central Jakarta, DKI Jakarta, Indonesia, 10430 |
Principal Investigator: | Aida R Tantri, PhD | Indonesia University |
Responsible Party: | Dr. dr. Aida Rosita Tantri SpAn-KA, Consultant, Anesthesiologist, Indonesia University |
ClinicalTrials.gov Identifier: | NCT03051022 |
Other Study ID Numbers: |
IndonesiaUAnes008 |
First Posted: | February 13, 2017 Key Record Dates |
Last Update Posted: | August 18, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Bupivacaine adjuvant regional anesthesia dexamethasone morphine |
Dexamethasone Morphine Bupivacaine Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Analgesics, Opioid Narcotics Analgesics |