Prevention of Hyperalgesia With Epidural Morphine
Does Preemptive Epidural Morphine Prevent Remifentanil Induced Hyperalgesia
1 other identifier
interventional
105
1 country
1
Brief Summary
American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups. Lumbar epidural catheter will be inserted to the all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6 mg/kg rocuronium. Desflurane and azot protoxit (N2O)-O2 will use for anaesthesia maintenance. During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural catheter before surgical incision. In group II, 1 mg morphine will apply from epidural catheter before surgical incision. In group III, 1 mg morphine will apply from epidural catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia will provide with bupivacaine for postoperative analgesia. Postoperative pain will be assessed with numerical pain scale. Postoperative analgesic requirement will be calculated. Hyperalgesia will detect with algometer and von Frey ligaments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2017
CompletedStudy Start
First participant enrolled
July 19, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 5, 2018
November 1, 2017
1.4 years
June 2, 2017
March 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative analgesic requirement
Calculation of epidural bupivacain consumption
Till the postoperative 24th hour.
Secondary Outcomes (1)
Algometer values
Till the postoperative 24th hour.
Study Arms (3)
serum physiologic
PLACEBO COMPARATOR2 ml serum physiologic will apply via epidural catheter before surgical incision.
Preemptive Morphine
ACTIVE COMPARATOR1 mg morphine will apply via epidural catheter before surgical incision.
Morphine
ACTIVE COMPARATOR1 mg morphine will apply via epidural catheter before at the time point of the peritoneum closed.
Interventions
Prevention of remifentanil induced hyperalgesia
For placebo, serum physiologic will use
Eligibility Criteria
You may qualify if:
- ASA I-III patients
- Patients who undergoing major abdominal surgery
You may not qualify if:
- ASA IV and up
- Coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Çukurova University Balcalı Hospital
Adana, 01380, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ebru Biricik
Cukurova University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 2, 2017
First Posted
July 21, 2017
Study Start
July 19, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
March 5, 2018
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share