Impact of Intrathecal Morphine on Sleep Apnea Syndrome

Phase 4

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Drug: Bupivacaine with intrathecal morphine; Drug: Bupivacaine with normal saline

• Registration Number: NCT02566226
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic episodes is unknown. The objective of this randomised controlled trial is to investigate the effect of intrathecal morphine and surgery on apneic episodes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Study Start: 2015-11
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

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

Inclusion Criteria

• physical status I - III
• patients scheduled to undergo hip arthroplasty

Exclusion Criteria

• planned surgical duration more than 3 hours
• contraindication to spinal anaesthesia
• severe respiratory disease
• patient known and treated for sleep apnea syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine with intrathecal morphine	Bupivacaine with intrathecal morphine	-
Bupivacaine with normal saline	Bupivacaine with normal saline	-

Primary Outcome Measures

Name	Time	Method
apnea hypopnea index while lying supine	postoperative night 0

Secondary Outcome Measures

Name	Time	Method
apnea hypopnea index while lying in another position than supine	postoperative night 0
mean pulse oxymetry	postoperative night 0
Berlin questionnaire	24 h before surgery
STOP-BANG questionnaire	24 h before surgery
Epworth questionnaire	24 h before surgery
postoperative nausea and vomiting (yes/no)	postoperative day 0, 1, 2 and 3
pain scores (numeric rating scale, 0-10)	postoperative day 0, 1, 2 and 3
oxycodone consumption (mg)	postoperative day 0, 1, 2 and 3
Pruritus (yes/no)	postoperative day 0, 1, 2 and 3

Trial Locations

Locations (1)

Lausanne University Hospital; 🇨🇭 Lausanne, Switzerland