Prevention of Hyperalgesia With Epidural Morphine
Primary Purpose
Hyperalgesia
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Morphine
Serum physiologic
Sponsored by
About this trial
This is an interventional prevention trial for Hyperalgesia
Eligibility Criteria
Inclusion Criteria:
- ASA I-III patients
- Patients who undergoing major abdominal surgery
Exclusion Criteria:
- ASA IV and up
- Coagulopathy
Sites / Locations
- Çukurova University Balcalı HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
serum physiologic
Preemptive Morphine
Morphine
Arm Description
2 ml serum physiologic will apply via epidural catheter before surgical incision.
1 mg morphine will apply via epidural catheter before surgical incision.
1 mg morphine will apply via epidural catheter before at the time point of the peritoneum closed.
Outcomes
Primary Outcome Measures
Postoperative analgesic requirement
Calculation of epidural bupivacain consumption
Secondary Outcome Measures
Algometer values
Postoperative pain will detect with algometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03225690
Brief Title
Prevention of Hyperalgesia With Epidural Morphine
Official Title
Does Preemptive Epidural Morphine Prevent Remifentanil Induced Hyperalgesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This randomized, double blind, controlled study will perform after obtaining informed consent and ethics approval. 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 with computerized randomization programme. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
serum physiologic
Arm Type
Placebo Comparator
Arm Description
2 ml serum physiologic will apply via epidural catheter before surgical incision.
Arm Title
Preemptive Morphine
Arm Type
Active Comparator
Arm Description
1 mg morphine will apply via epidural catheter before surgical incision.
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
1 mg morphine will apply via epidural catheter before at the time point of the peritoneum closed.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Group I-II
Intervention Description
Prevention of remifentanil induced hyperalgesia
Intervention Type
Drug
Intervention Name(s)
Serum physiologic
Other Intervention Name(s)
Group III
Intervention Description
For placebo, serum physiologic will use
Primary Outcome Measure Information:
Title
Postoperative analgesic requirement
Description
Calculation of epidural bupivacain consumption
Time Frame
Till the postoperative 24th hour.
Secondary Outcome Measure Information:
Title
Algometer values
Description
Postoperative pain will detect with algometer
Time Frame
Till the postoperative 24th hour.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA I-III patients
Patients who undergoing major abdominal surgery
Exclusion Criteria:
ASA IV and up
Coagulopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebru Biricik
Phone
5052420223
Email
ebrubiricik01@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Feride Karacaer
Phone
5062628416
Email
feridekaracaer@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Biricik
Organizational Affiliation
Cukurova University
Official's Role
Study Chair
Facility Information:
Facility Name
Çukurova University Balcalı Hospital
City
Adana
ZIP/Postal Code
01380
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Çukurova University B Hospital
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Hyperalgesia With Epidural Morphine
We'll reach out to this number within 24 hrs