Observation of Respiration Following Regional Anaesthesia With Intrathecal Opioids for Caesarean Section
This study has been completed.
Information provided by:
NHS Greater Clyde and Glasgow
First received: October 12, 2007
Last updated: February 3, 2009
Last verified: February 2009
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.
||Observational Model: Cohort
Time Perspective: Prospective
||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)
Primary Outcome Measures:
- transcutaneous carbon dioxide tension [ Time Frame: within the first 24 hours after surgery ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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:
| Study Completion Date:
| 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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Elective caesarean section Healthy pregnant women
- 1st patient on list
- ASA I or II
- BMI <40 at booking
- Term pregnancy +/- 2 weeks gestation
- BMI>40 at booking
- History of Obstructive Sleep Apnoea (OSA)
- Need for supplementation with intravenous Opioids intraoperatively
- Conversion to GA
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00544947
|Princess Royal Maternity Hospital
|Glasgow, United Kingdom, G4 0SF |
NHS Greater Clyde and Glasgow
||Stephan Dalchow, FRCA
||National Health Service
||Dr Stephan Dalchow, NHS Greater Clyde&Glasgow
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 12, 2007
||February 3, 2009
||United Kingdom: Research Ethics Committee
Keywords provided by NHS Greater Clyde and Glasgow:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 25, 2016
Respiratory Tract Diseases