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Bupivacaine, Levobupivacaine and Ropivacaine After Intrathecal and Extradural Injection in Labour

This study has suspended participant recruitment.
(Audit pre regulatory inspection)
Sponsor:
Information provided by:
NHS Tayside
ClinicalTrials.gov Identifier:
NCT01201213
First received: September 13, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

A need exists to define the best local anaesthetic and technique for pain relief in early labour. We suggest that calculating the molar ED50 for bupivacaine, levobupivacaine and ropivacaine given both by the intrathecal (as a CSE) and epidural routes would provide a valid comparison between the pain relieving properties of all three drugs, from which a reasoned assessment of side effects can be made.


Condition Intervention Phase
Pain
 Drug: local anaesthetic injection
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Median Effective Concentration of Bupivacaine, Levobupivacaine and Ropivacaine After Intrathecal and Extradural Injection for Pain Relief in the First Stage of Labour

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NHS Tayside:

Primary Outcome Measures:
  • Visual analogue pain score at 30minutes after epidural injection [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    To determine the median effective concentration of bupivacaine, levobupivacaine and ropivacaine after intrathecal and extradural injection for pain relief in the first stage of labour.


Secondary Outcome Measures:
  • Motor block [ Time Frame: 45 minutes ] [ Designated as safety issue: Yes ]
    To chart a derived dose response curve for bupivacaine, levobupivacaine and ropivacaine after intrathecal and extradural injection Determine the intrathecal / epidural potency ratio of each drug To measure the degree of motor block using Bromage and Straight Leg Raising scales To measure side effects such as hypotension, nausea and vomiting To measure mode of delivery and fetal outcome


Estimated Enrollment: 162
Study Start Date: September 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Extradural bupivacaine Drug: local anaesthetic injection
Single bolus of drug for pain relief in early labour
Active Comparator: Extradural levobupivacaine Drug: local anaesthetic injection
Single bolus of drug for pain relief in early labour
Active Comparator: Extradural ropivacaine Drug: local anaesthetic injection
Single bolus of drug for pain relief in early labour
Active Comparator: Intrathecal bupivacaine Drug: local anaesthetic injection
Single bolus of drug for pain relief in early labour
Active Comparator: Intrathecal levobupivacaine Drug: local anaesthetic injection
Single bolus of drug for pain relief in early labour
Active Comparator: Intrathecal ropivacaine Drug: local anaesthetic injection
Single bolus of drug for pain relief in early labour

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is aged > 18 years
  • The patient is in early labour ≤ 5cm cervical dilatation
  • The patient is ASA Grade I - II
  • The patient provides written informed consent to participate in the trial prior to surgery

Exclusion Criteria:

  • The patient has any known chronic medical condition for which regular medication is required
  • The patient has received any investigational drug within the 90 days prior to the study or is scheduled to receive one during the study period
  • The patient is scheduled for caesarean section
  • The patient has received opioids in the last 4 hours
  • The patient has evidence of alcohol or drug abuse
  • There is evidence of obstetric complications
  • The fetus has shown signs of intrauterine growth retardation
  • The patient has findings on pre-study evaluations (e.g. laboratory results, medical history, physical examination, ECG) that are clinically significant in the investigator's opinion such to exclude entry into the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201213

Locations
United Kingdom
Ninewells Hospital & Medical School
Dundee, Tayside, Scotland, United Kingdom, DD19SY
Sponsors and Collaborators
NHS Tayside
Investigators
Principal Investigator: Graeme A McLeod, MD FRCA NHS Tayside
  More Information

No publications provided

Responsible Party: Dr A Russell, NHS Tayside
ClinicalTrials.gov Identifier: NCT01201213     History of Changes
Other Study ID Numbers: 2007AN01
Study First Received: September 13, 2010
Last Updated: September 13, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Tayside:
Bupivacaine
levobupivacaine
ropivacaine

Additional relevant MeSH terms:
Anesthetics, Local
Bupivacaine
Ropivacaine
Levobupivacaine
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013