Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Remifentanil+morphine

• Registration Number: NCT01830296
• Lead Sponsor: Cukurova University

Brief Summary

Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized study tested the effects of coadministration of patient controlled remifentanil+morphine combination on postthoracotomy pain, analgesic consumption and side effects compared with morphine PCA alone

Detailed Description

Methods; Sixty patients were allocated randomly to receive an intravenous patient-controlled analgesia with morphine alone (M), or morphine plus remifentanil (MR), in a double-blind manner. Postoperatively patients were allowed to use bolus doses of morphine (0.2 mg kg-1) or morphine (0.2 mg kg-1) plus remifentanil (0.2 µg kg-1) mixture every 10 min without a background infusion. Pain, discomfort, sedation scores, total and bolus patient-controlled morphine consumption, rescue analgesic requirement and side-effects were recorded for up to 24 h after the start of patient-controlled analgesia.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Study First Submitted: 2013-03-27
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-10
• Last Update Submitted: 2013-04-10
• Study First Posted: 2013-04-12
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 60 ASA physical status I-III patients, between the ages of 18 and 59 years, scheduled for elective thoracotomy surgery with general anaesthesia were included in this study

Exclusion Criteria

• severe hepatorenal disease history, sensitivity or contraindication to morphine and remifentanil, chronic pain (defined as regular use of opioid analgesics for > 3 months), drug or alcohol abuse and contraindication to administration of PCA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Remifentanil+Morphine	Remifentanil+morphine	Morphine(M) Remifentanil+Morphine(MR)
IV morphine PCA	Remifentanil+morphine	IV remifentanil+morphine PCA

Primary Outcome Measures

Name	Time	Method
COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE	Two years	As aim of this study was to evaluate the effects of remifentanil addition to morphine for i.v. PCA on analgesic consumption, the primary endpoint was defined as morphine consumption at 24 hour.

Trial Locations

Locations (1)

Hakkı Unlugenc; 🇹🇷 Adana, Turkey