Observation of Respiration Following Regional Anaesthesia With Intrathecal Opioids for Caesarean Section
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.
|Study Design:||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)|
- transcutaneous carbon dioxide tension [ Time Frame: within the first 24 hours after surgery ] [ Designated as safety issue: Yes ]
- oxygen-saturation, respiratory rate, neurological status, need for administration of naloxone and/or active airway management [ Time Frame: within first 24 hours after surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00544947
|Princess Royal Maternity Hospital|
|Glasgow, United Kingdom, G4 0SF|
|Principal Investigator:||Stephan Dalchow, FRCA||National Health Service|