Prevention of Hyperalgesia With Epidural Morphine

Phase 4

• Conditions: Hyperalgesia
• Interventions: Drug: Serum physiologic; Drug: Morphine

• Registration Number: NCT03225690
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Study First Submitted: 2017-06-02
• Study Start: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Status Verified: 2017-11
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• ASA I-III patients
• Patients who undergoing major abdominal surgery

Exclusion Criteria

• ASA IV and up
• Coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
serum physiologic	Serum physiologic	2 ml serum physiologic will apply via epidural catheter before surgical incision.
Preemptive Morphine	Morphine	1 mg morphine will apply via epidural catheter before surgical incision.
Morphine	Morphine	1 mg morphine will apply via epidural catheter before at the time point of the peritoneum closed.

Primary Outcome Measures

Name	Time	Method
Postoperative analgesic requirement	Till the postoperative 24th hour.	Calculation of epidural bupivacain consumption

Secondary Outcome Measures

Name	Time	Method
Algometer values	Till the postoperative 24th hour.	Postoperative pain will detect with algometer

Trial Locations

Locations (1)

Çukurova University Balcalı Hospital; 🇹🇷 Adana, Turkey