Impact of Intrathecal Morphine on Sleep Apnea Syndrome

November 1, 2019 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland
        • Lausanne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Bupivacaine with normal saline
Drug: Bupivacaine with normal saline
Isobaric bupivacaine 15 mg + normal saline 0.5 cc
Active Comparator: Bupivacaine with intrathecal morphine
Drug: Bupivacaine with intrathecal morphine
Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
apnea hypopnea index while lying supine
Time Frame: postoperative night 0
postoperative night 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Eric Albrecht, MD, Lausanne University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 265/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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