asal versus Epidural Fentanyl for Patient Controlled Analgesia after Caesarean Sectio

Phase 4

Recruiting

• Conditions: Postoperative pain following caesarean section.; Reproductive Health and Childbirth - Normal pregnancy; Alternative and Complementary Medicine - Pain management; Surgery - Other surgery

• Registration Number: ACTRN12605000327684
• Lead Sponsor: Professor Michael Paech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

.Scheduled for elective or non-urgent Caesarean section under combined spinal-epidural anaesthesia and consenting to use patient-controlled analgesia.

Exclusion Criteria

Anaesthesia other than combined spinal-epiduralUnsuitable for postoperative epidural analgesia or patient-controlled analgesiaAllergy or intolerance to fentanylCurrent opioid or magnesium therapyHistory of nasal pathologyMajor surgical complication rendering use of patient-controlled techniques inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient rating of satisfaction (as a percentage and using the following scale: dissatisfied, somewhat dissatisfied, neither satisfied nor dissatisfied, somewhat satisfied, satisfied) with the method of pain relief[Assessed at 18 hours (just prior to crossover) and at 36 hours]

Secondary Outcome Measures

Name	Time	Method
Pain score (0-100 visual analogue scale - VAS) and side effects (nausea, pruritus, sedation).[Assessed at regular intervals during the 36 hours (pain scores taken from time of first activation of PCA devices at 5, 15, 30, 60 minutes and 4, 8, 12, 18, 22, 26, 30 and 36 hours; side effects to be assessed at 18 hours just prior to crossover and at 36 hours).];Requirment for resuce analgesia[During each of 1st and 2nd 18 hour periods.];Quality of Recovery Sore, Modified Brief Pain Inventory Score & Health Outcomes Recovery Survey[At 18 and 36 hours.];Physical assessment of infant to assess tone and alertness.[At 18 hours ];A subgroup of 20 patients will have a series of blood samples taken for pharmacokinetic studies.[At 4, 8, 18, 22, 26 and 36 hours from time of first activation of PCEA pumps.]