Comparison Between Dexamethasone and Morphine as an Adjuvant to Bupivacaine for Post-operative Analgesia

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03051022
• Date of registration: 05/02/2017
• Prospective Registration: No
• Primary sponsor: Indonesia University
• Public title: Comparison Between Dexamethasone and Morphine as an Adjuvant to Bupivacaine for Post-operative Analgesia
• Scientific title: The Comparison Between Dexamethasone and Morphine as an Adjuvant to Epidural Bupivacaine for Post-operative Analgesia in Lower Extremity Surgery
• Date of first enrolment: May 1, 2016
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03051022
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Aida R Tantri, PhD
• Affiliation: Indonesia University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lower Extremities Fracture

Intervention(s)

Drug: Dexamethasone 8 mg

Drug: Morphine 2 mg

Primary Outcome(s)

The degree of pain at 24-hours post-operative [Time Frame: 24 hours post-operative]

The time for first requested post-operative additional analgesia [Time Frame: 24 hours post-operative]

The opioid requirement with the first 24-hours post-operative [Time Frame: 24-hours post-operative]

Secondary Outcome(s)

Side Effects [Time Frame: 24-hours post-operative]

Secondary ID(s)

IndonesiaUAnes008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors