Prevention of Hyperalgesia With Epidural Morphine

Overview

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.

Full Title of Study: “Does Preemptive Epidural Morphine Prevent Remifentanil Induced Hyperalgesia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 1, 2018

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.

Interventions

  • Drug: Morphine
    • Prevention of remifentanil induced hyperalgesia
  • Drug: Serum physiologic
    • For placebo, serum physiologic will use

Arms, Groups and Cohorts

  • Placebo Comparator: serum physiologic
    • 2 ml serum physiologic will apply via epidural catheter before surgical incision.
  • Active Comparator: Preemptive Morphine
    • 1 mg morphine will apply via epidural catheter before surgical incision.
  • Active Comparator: Morphine
    • 1 mg morphine will apply via epidural catheter before at the time point of the peritoneum closed.

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative analgesic requirement
    • Time Frame: Till the postoperative 24th hour.
    • Calculation of epidural bupivacain consumption

Secondary Measures

  • Algometer values
    • Time Frame: Till the postoperative 24th hour.
    • Postoperative pain will detect with algometer

Participating in This Clinical Trial

Inclusion Criteria

  • ASA I-III patients – Patients who undergoing major abdominal surgery Exclusion Criteria:

  • ASA IV and up – Coagulopathy

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cukurova University
  • Provider of Information About this Clinical Study
    • Principal Investigator: ebru biricik, Dr – Cukurova University
  • Overall Official(s)
    • Ebru Biricik, Study Chair, Cukurova University
  • Overall Contact(s)
    • Ebru Biricik, 5052420223, ebrubiricik01@gmail.com

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