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Prevention of Hyperalgesia With Epidural Morphine

Sponsor
Cukurova University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03225690
Collaborator
(none)
105
Enrollment
1
Location
3
Arms
16.4
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Does Preemptive Epidural Morphine Prevent Remifentanil Induced Hyperalgesia
Actual Study Start Date :
Jul 19, 2017
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: serum physiologic

2 ml serum physiologic will apply via epidural catheter before surgical incision.

Drug: Serum physiologic
For placebo, serum physiologic will use
Other Names:
  • Group III

    		•
    Active Comparator: Preemptive Morphine

    1 mg morphine will apply via epidural catheter before surgical incision.

    Drug: Morphine
    Prevention of remifentanil induced hyperalgesia
    Other Names:
  • Group I-II

    		•
    Active Comparator: Morphine

    1 mg morphine will apply via epidural catheter before at the time point of the peritoneum closed.

    Drug: Morphine
    Prevention of remifentanil induced hyperalgesia
    Other Names:
  • Group I-II

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative analgesic requirement [Till the postoperative 24th hour.]

      Calculation of epidural bupivacain consumption

    Secondary Outcome Measures

    1. Algometer values [Till the postoperative 24th hour.]

      Postoperative pain will detect with algometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • ASA I-III patients

    • Patients who undergoing major abdominal surgery

    Exclusion Criteria:

    • ASA IV and up

    • Coagulopathy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Çukurova University Balcalı Hospital Adana Turkey 01380

    Sponsors and Collaborators

    • Cukurova University

    Investigators

    • Study Chair: Ebru Biricik, Cukurova University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ebru biricik, Dr, Cukurova University
    ClinicalTrials.gov Identifier:
    NCT03225690
    Other Study ID Numbers:
    • Hyperalgesia
    First Posted:
    Jul 21, 2017
    Last Update Posted:
    Mar 5, 2018
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Hyperalgesia
    Morphine

    Study Results

    No Results Posted as of Mar 5, 2018