Impact of Intrathecal Morphine on Sleep Apnea Syndrome
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 2, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedNovember 4, 2019
November 1, 2019
3.3 years
September 28, 2015
November 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
apnea hypopnea index while lying supine
postoperative night 0
Secondary Outcomes (9)
apnea hypopnea index while lying in another position than supine
postoperative night 0
mean pulse oxymetry
postoperative night 0
STOP-BANG questionnaire
24 h before surgery
Berlin questionnaire
24 h before surgery
Epworth questionnaire
24 h before surgery
- +4 more secondary outcomes
Study Arms (2)
Bupivacaine with normal saline
PLACEBO COMPARATORBupivacaine with intrathecal morphine
ACTIVE COMPARATORInterventions
Isobaric bupivacaine 15 mg + normal saline 0.5 cc
Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg
Eligibility Criteria
You may qualify if:
- physical status I - III
- patients scheduled to undergo hip arthroplasty
You may not qualify if:
- planned surgical duration more than 3 hours
- contraindication to spinal anaesthesia
- severe respiratory disease
- patient known and treated for sleep apnea syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lausanne University Hospital
Lausanne, Switzerland
Related Publications (2)
Albrecht E, Wegrzyn J, Rossel JB, Bayon V, Heinzer R. Impact of spinal versus general anaesthesia on perioperative obstructive sleep apnoea severity in patients undergoing hip arthroplasty: a post hoc analysis of two randomised controlled trials. Br J Anaesth. 2024 Aug;133(2):416-423. doi: 10.1016/j.bja.2024.04.051. Epub 2024 Jun 10.
PMID: 38862381DERIVEDAlbrecht E, Bayon V, Hirotsu C, Al Ja'bari A, Heinzer R. Intrathecal morphine and sleep apnoea severity in patients undergoing hip arthroplasty: a randomised, controlled, triple-blinded trial. Br J Anaesth. 2020 Nov;125(5):811-817. doi: 10.1016/j.bja.2020.07.052. Epub 2020 Sep 6.
PMID: 32900508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Albrecht, MD
University of Lausanne Hospitals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Director, Regional Anaesthesia
Study Record Dates
First Submitted
September 28, 2015
First Posted
October 2, 2015
Study Start
November 1, 2015
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
November 4, 2019
Record last verified: 2019-11