Ropivacaine 0.75% Versus Levobupivacaine 0.5% for Conversion of Labour Epidural

NCT01160965 | Withdrawn Phase 4 DMC

• 2 other identifiers: Version1.02010-021783-15
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to compare the local anaesthetic ropivacaine to local anaesthetic levobupivacaine in converting the standard patient controlled labour epidural to provide anaesthesia for an emergency Caesarean section. This is a technique commonly known as an epidural top-up. The investigators set out to disprove the hypothesis that there is no difference between the 2 local anaesthetics in the time of onset and number of times epidural top-up needs supplementing during surgery.

Conditions

Caesarean Section

Keywords

epidural top-up; emergency Caesarean section

Outcome Measures

Primary Outcomes (1)

• Supplementation Rate

  The number of times the epidural anaesthetic requires intra-operative supplementation with more study solution or another drug for pain.

  During operation (approximately 1 hour )

Secondary Outcomes (9)

• Pre-operative supplementation

  10-45mins (top-up to start of surgery)

• Pain

  During operation (approximately 1 hour)

• Conversion Rate

  At any point between epidural top-up and end of operation (approximately 90mins from epidural top-up)

• Side effects

  At any point between top-up of epidural and end of operation (approximately 90mins from epidural top-up)

• Blood pressure supplementation rate

  At any point from top-up of epidural to end of operation (approximately 90mins from epidural top-up)

Study Arms (2)

0.5% levobupivacaine

ACTIVE COMPARATOR

Participants given 15mls of 0.5% levobupivacaine as the solution for their epidural top-up

Drug: 0.5% levobupivacaine

0.75% Rpoivacaine

ACTIVE COMPARATOR

Participants given 15mls of 0.75% ropivacaine as the solution for their epidural top-up.

Drug: 0.75% Ropivacaine

Interventions

0.5% levobupivacaine DRUG

15mls of a 5mg/ml solution of the local anaesthetic levobupivacaine given via the epidural catheter.

Also known as: 0.5% Chirocaine

0.5% levobupivacaine

0.75% Ropivacaine DRUG

15mls of a 7.5mg/ml solution of the local anaesthetic ropivacaine given via the epidural catheter.

0.75% Rpoivacaine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Any subject requiring a grade 2 or 3 EmCS on the Hospital Birth Centre, St Thomas' who has:
• Labour analgesia provided by the standard patient controlled epidural (solution containing 0.1% levobupivacaine and 2mcg/ml fentanyl). That is providing analgesia via the patient controlled epidural analgesia infusion pump without the need for multiple extra boluses of epidural local anaesthetic and or opiates from the anaesthetist on the labour ward..
• Singleton pregnancy.
• Established labour, determined by the midwife responsible for the patient (usually by vaginal examination of the cervix).
• Gestation \>36 weeks
• No complex past medical history according to the judgement of the investigator
• \> 18 years of age
• EmCS starts between the hours 0800 and 1800.
• The ability to understand the patient information sheet and willing to provide informed consent.
• Had a minimal total dose of 50mcg of fentanyl since insertion of epidural

You may not qualify if:

• Pre-eclampsia / Eclampsia
• Antepartum haemorrhage
• Any congenital, structural or ischaemic heart disease.
• Category 1 EmCS.
• Participation in another therapeutic study in the last 12 weeks. -

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

• Sanders RD, Mallory S, Lucas DN, Chan T, Yeo S, Yentis SM. Extending low-dose epidural analgesia for emergency Caesarean section using ropivacaine 0.75%. Anaesthesia. 2004 Oct;59(10):988-92. doi: 10.1111/j.1365-2044.2004.03753.x.

  PMID: 15488058 RESULT

• Sng BL, Pay LL, Sia AT. Comparison of 2% lignocaine with adrenaline and fentanyl, 0.75% ropivacaine and 0.5% levobupivacaine for extension of epidural analgesia for urgent caesarean section after low dose epidural infusion during labour. Anaesth Intensive Care. 2008 Sep;36(5):659-64. doi: 10.1177/0310057X0803600505.

  PMID: 18853583 RESULT

MeSH Terms

Interventions

Levobupivacaine; Ropivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• geraldine e o'sullivan, MBBCh

  Guy's and St Thomas' NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 13, 2010
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: December 29, 2011

Record last verified: 2011-12

Locations

GB (1)