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

NCT00544947 | Completed

• 1 other identifier: 07/S0704/67
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Depression

Keywords

Respiratory Depression; Caesarean Section; Diamorphine; Fentanyl

Outcome Measures

Primary Outcomes (1)

• transcutaneous carbon dioxide tension

  within the first 24 hours after surgery

Secondary Outcomes (1)

• oxygen-saturation, respiratory rate, neurological status, need for administration of naloxone and/or active airway management

  within first 24 hours after surgery

Study Arms (1)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elective caesarean section Healthy pregnant women

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NHS Greater Clyde and Glasgow: lead

Study Sites (1)

Princess Royal Maternity Hospital

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Stephan Dalchow, FRCA

  National Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2007
• First Posted: October 16, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 4, 2009

Record last verified: 2009-02

Locations

GB (1)