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Observation of Respiration Following Regional Anaesthesia With Intrathecal Opioids for Caesarean Section

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ClinicalTrials.gov Identifier: NCT00544947
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : February 4, 2009
Sponsor:
Information provided by:
NHS Greater Clyde and Glasgow

Brief Summary:
Spinal Administration of opioids offers segmental analgesia, but has side effects including pruritus, nausea and vomiting, urinary retention, hypotension, and respiratory depression, both early and delayed. Many Centres in the UK now routinely use supplementation of spinal anaesthesia from bupivacaine with intrathecal fentanyl or diamorphine. If Fentanyl is used, this is usually accompanied by connection to a i.v. Morphine patient-controlled analgesia (PCA)-device in the postoperative period, whereas the use of intrathecal diamorphine seems to result in a reduction in post-operative morphine requirements, which has obviated the need for PCA devices in many centres. There has been recent controversy over which opioid is safer to use with regards to the risk of respiratory depression.1,2 The investigators want to investigate, whether intrathecal diamorphine causes less or more post-operative respiratory depression in healthy mothers undergoing elective caesarean section than intrathecal fentanyl plus post-operative morphine PCA.

Condition or disease
Respiratory Depression

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observation of Respiration Following Regional Anaesthesia With Intrathecal Opioids: a Comparison Between Diamorphine and Fentanyl Combined With Postoperative Morphine PCA Using a Carbon Dioxide Tension and Pulse Oximetry Sensor (TOSCA)
Study Start Date : October 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl
U.S. FDA Resources

Group/Cohort
D, F

Group D will be patients at Princess Royal Maternity Hospital in Glasgow, where supplementation with intrathecal diamorphine 300mcg is the current anaesthetic technique of choice.

Group F will be patients at the Queen Mother's Maternity Hospital in Glasgow, where supplementation with intrathecal fentanyl 15mcg plus post-operative morphine PCA is the current anaesthetic technique of choice for elective caesarean section.




Primary Outcome Measures :
  1. transcutaneous carbon dioxide tension [ Time Frame: within the first 24 hours after surgery ]

Secondary Outcome Measures :
  1. oxygen-saturation, respiratory rate, neurological status, need for administration of naloxone and/or active airway management [ Time Frame: within first 24 hours after surgery ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elective caesarean section Healthy pregnant women
Criteria

Inclusion Criteria:

  • 1st patient on list
  • ASA I or II
  • BMI <40 at booking
  • Term pregnancy +/- 2 weeks gestation

Exclusion Criteria:

  • ASA>II
  • BMI>40 at booking
  • History of Obstructive Sleep Apnoea (OSA)
  • Need for supplementation with intravenous Opioids intraoperatively
  • Conversion to GA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544947


Locations
United Kingdom
Princess Royal Maternity Hospital
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
NHS Greater Clyde and Glasgow
Investigators
Principal Investigator: Stephan Dalchow, FRCA National Health Service

Responsible Party: Dr Stephan Dalchow, NHS Greater Clyde&Glasgow
ClinicalTrials.gov Identifier: NCT00544947     History of Changes
Other Study ID Numbers: 07/S0704/67
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by NHS Greater Clyde and Glasgow:
Respiratory Depression
Caesarean Section
Diamorphine
Fentanyl

Additional relevant MeSH terms:
Depression
Respiratory Insufficiency
Behavioral Symptoms
Respiration Disorders
Respiratory Tract Diseases
Fentanyl
Heroin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics