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Impact of Intrathecal Morphine on Sleep Apnea Syndrome

Primary Purpose

Sleep Apnea Syndromes

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Bupivacaine with normal saline
Bupivacaine with intrathecal morphine
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep Apnea Syndromes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lausanne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Bupivacaine with normal saline

Bupivacaine with intrathecal morphine

Arm Description

Outcomes

Primary Outcome Measures

apnea hypopnea index while lying supine

Secondary Outcome Measures

apnea hypopnea index while lying in another position than supine
mean pulse oxymetry
STOP-BANG questionnaire
Berlin questionnaire
Epworth questionnaire
pain scores (numeric rating scale, 0-10)
oxycodone consumption (mg)
postoperative nausea and vomiting (yes/no)
Pruritus (yes/no)

Full Information

First Posted
September 28, 2015
Last Updated
November 1, 2019
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT02566226
Brief Title
Impact of Intrathecal Morphine on Sleep Apnea Syndrome
Official Title
Impact of Intrathecal Morphine on Sleep Apnea Syndrome After Hip Arthroplasty Performed Under Spinal Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine with normal saline
Arm Type
Placebo Comparator
Arm Title
Bupivacaine with intrathecal morphine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacaine with normal saline
Intervention Description
Isobaric bupivacaine 15 mg + normal saline 0.5 cc
Intervention Type
Drug
Intervention Name(s)
Bupivacaine with intrathecal morphine
Intervention Description
Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg
Primary Outcome Measure Information:
Title
apnea hypopnea index while lying supine
Time Frame
postoperative night 0
Secondary Outcome Measure Information:
Title
apnea hypopnea index while lying in another position than supine
Time Frame
postoperative night 0
Title
mean pulse oxymetry
Time Frame
postoperative night 0
Title
STOP-BANG questionnaire
Time Frame
24 h before surgery
Title
Berlin questionnaire
Time Frame
24 h before surgery
Title
Epworth questionnaire
Time Frame
24 h before surgery
Title
pain scores (numeric rating scale, 0-10)
Time Frame
postoperative day 0, 1, 2 and 3
Title
oxycodone consumption (mg)
Time Frame
postoperative day 0, 1, 2 and 3
Title
postoperative nausea and vomiting (yes/no)
Time Frame
postoperative day 0, 1, 2 and 3
Title
Pruritus (yes/no)
Time Frame
postoperative day 0, 1, 2 and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, MD
Organizational Affiliation
Lausanne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lausanne University Hospital
City
Lausanne
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32900508
Citation
Albrecht 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.
Results Reference
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Impact of Intrathecal Morphine on Sleep Apnea Syndrome

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