Prevention of Hyperalgesia With Epidural Morphine

NCT ID: NCT03225690

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-19
• Study Completion Date: 2018-12-01

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.

Conditions

Hyperalgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

serum physiologic

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

Group Type: PLACEBO_COMPARATOR

Serum physiologic

Intervention Type: DRUG

For placebo, serum physiologic will use

Preemptive Morphine

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

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Prevention of remifentanil induced hyperalgesia

Morphine

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

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Prevention of remifentanil induced hyperalgesia

Interventions

Morphine

Prevention of remifentanil induced hyperalgesia

Intervention Type: DRUG

Serum physiologic

For placebo, serum physiologic will use

Intervention Type: DRUG

Other Intervention Names

Group I-II; Group III

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• ASA IV and up
• Coagulopathy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

ebru biricik

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Biricik

Role: STUDY_CHAIR

Cukurova University

Locations

Çukurova University Balcalı Hospital

Adana, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ebru Biricik

Role: CONTACT

ebrubiricik01@gmail.com

5052420223

Feride Karacaer

Role: CONTACT

feridekaracaer@gmail.com

5062628416

Facility Contacts

Çukurova University B Hospital

Role: primary

Other Identifiers

Hyperalgesia

Identifier Type: -

Identifier Source: org_study_id