Impact of Intrathecal Morphine on Sleep Apnea Syndrome

Vaud University Hospital Center

Status and phase: Completed; Phase 4

Conditions: Sleep Apnea Syndromes

Treatments: Drug: Bupivacaine with intrathecal morphine; Drug: Bupivacaine with normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02566226

CER 265/15

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Bupivacaine with normal saline

Placebo Comparator group

Treatment:

Drug: Bupivacaine with normal saline

Bupivacaine with intrathecal morphine

Active Comparator group

Treatment:

Drug: Bupivacaine with intrathecal morphine