Prevention of Hyperalgesia With Epidural Morphine

Hyperalgesia Clinical Trial

Official title:

Does Preemptive Epidural Morphine Prevent Remifentanil Induced Hyperalgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03225690
• Other study ID #: Hyperalgesia
• Status: Recruiting
• Phase: Phase 4
• First received: June 2, 2017
• Last updated: March 2, 2018
• Start date: July 19, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: November 2017
• Source: Cukurova University
• Contact: Ebru Biricik
• Phone: 5052420223
• Email: ebrubiricik01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA I-III patients

• Patients who undergoing major abdominal surgery

Exclusion Criteria:

• ASA IV and up

• Coagulopathy

Related Conditions & MeSH terms

• Hyperalgesia

Intervention

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

Locations

Country	Name	City	State
Turkey	Çukurova University Balcali Hospital	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesic requirement	Calculation of epidural bupivacain consumption	Till the postoperative 24th hour.
Secondary	Algometer values	Postoperative pain will detect with algometer	Till the postoperative 24th hour.