Sleep Apnea SyndromesPhase 4NCT02566226
Impact of Intrathecal Morphine on Sleep Apnea Syndrome
A Phase 4 study testing Bupivacaine with normal saline and Bupivacaine with intrathecal morphine in people with Sleep Apnea Syndromes, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Bupivacaine with normal saline and Bupivacaine with intrathecal morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2015to Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physical status I - III
- patients scheduled to undergo hip arthroplasty
Who cannot join
- planned surgical duration more than 3 hours
- contraindication to spinal anaesthesia
- severe respiratory disease
- patient known and treated for sleep apnea syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Intrathecal Morphine on Sleep Apnea Syndrome After Hip Arthroplasty Performed Under Spinal Anaesthesia
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.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Bupivacaine with normal saline, Bupivacaine with intrathecal morphine
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine with normal salineDrug
Isobaric bupivacaine 15 mg + normal saline 0.5 cc
Bupivacaine with intrathecal morphineDrug
Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine with normal saline | Placebo comparator | Not described Receives: Drug: Bupivacaine with normal saline |
| Bupivacaine with intrathecal morphine | Active comparator | Not described Receives: Drug: Bupivacaine with intrathecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea hypopnea index while lying supine
Measured: postoperative night 0
Secondary outcomes (9)
apnea hypopnea index while lying in another position than supine
Measured: postoperative night 0
mean pulse oxymetry
Measured: postoperative night 0
STOP-BANG questionnaire
Measured: 24 h before surgery
Berlin questionnaire
Measured: 24 h before surgery
Epworth questionnaire
Measured: 24 h before surgery
pain scores (numeric rating scale, 0-10)
Measured: postoperative day 0, 1, 2 and 3
oxycodone consumption (mg)
Measured: postoperative day 0, 1, 2 and 3
postoperative nausea and vomiting (yes/no)
Measured: postoperative day 0, 1, 2 and 3
Pruritus (yes/no)
Measured: postoperative day 0, 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Albrecht, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566226
- Sponsor's protocol ID
- CER 265/15
- Status last verified
- Nov 2019
- First submitted
- 28 Sep 2015
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38862381Albrecht 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.
PubMed 32900508
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intrathecal Morphine on Sleep Apnea Syndrome After Hip Arthroplasty Performed Under Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT02566226
- Acronym / sponsor ID
- CER 265/15
- Conditions
- Sleep Apnea Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine with normal saline | Placebo comparator | Drug: Bupivacaine with normal saline |
| Bupivacaine with intrathecal morphine | Active comparator | Drug: Bupivacaine with intrathecal morphine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- physical status I - III
- patients scheduled to undergo hip arthroplasty
Key exclusion criteria (4 listed)
- planned surgical duration more than 3 hours
- contraindication to spinal anaesthesia
- severe respiratory disease
- patient known and treated for sleep apnea syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine with normal salineIsobaric bupivacaine 15 mg + normal saline 0.5 cc | Drug | Bupivacaine with normal saline |
| Bupivacaine with intrathecal morphineIsobaric bupivacaine 15 mg + intrathecal morphine 100 mcg | Drug | Bupivacaine with intrathecal morphine |
Primary outcome
apnea hypopnea index while lying supine
Time frame: postoperative night 0
9 secondary outcomes
apnea hypopnea index while lying in another position than supine
Time frame: postoperative night 0
mean pulse oxymetry
Time frame: postoperative night 0
STOP-BANG questionnaire
Time frame: 24 h before surgery
Berlin questionnaire
Time frame: 24 h before surgery
Epworth questionnaire
Time frame: 24 h before surgery
pain scores (numeric rating scale, 0-10)
Time frame: postoperative day 0, 1, 2 and 3
oxycodone consumption (mg)
Time frame: postoperative day 0, 1, 2 and 3
postoperative nausea and vomiting (yes/no)
Time frame: postoperative day 0, 1, 2 and 3
Pruritus (yes/no)
Time frame: postoperative day 0, 1, 2 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Derived from this study: PubMed 38862381Albrecht 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.
- Derived from this study: PubMed 32900508Albrecht 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Albrecht, MD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine with normal saline and Bupivacaine with intrathecal morphine in people with Sleep Apnea Syndromes, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea hypopnea index while lying supine (time frame: postoperative night 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02566226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.