Impact of Intrathecal Morphine on Sleep Apnea Syndrome

Sleep Apnea Syndromes Clinical Trial

Official title:

Impact of Intrathecal Morphine on Sleep Apnea Syndrome After Hip Arthroplasty Performed Under Spinal Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566226
• Other study ID #: CER 265/15
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: March 2019

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The objective of this randomised controlled trial is to investigate the effect of intrathecal morphine and surgery on apneic episodes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Syndrome

Intervention

Drug:
• Bupivacaine with normal saline
Isobaric bupivacaine 15 mg + normal saline 0.5 cc
• Bupivacaine with intrathecal morphine
Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

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