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

NCT01201213 | Terminated Phase 4

• 1 other identifier: 2007AN01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

A need exists to define the best local anesthetic and technique for pain relief in early labour. We suggest that calculating the molar Median Effective Dose for bupivacaine, levobupivacaine and ropivacaine given both by the intrathecal (as a combined spinal epidural 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.

Conditions

Pain

Keywords

Bupivacaine; levobupivacaine; ropivacaine

Outcome Measures

Primary Outcomes (1)

• Visual analogue pain score at 30minutes after epidural injection

  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.

  30 minutes

Secondary Outcomes (1)

• Motor block

  45 minutes

Study Arms (6)

Extradural bupivacaine

ACTIVE COMPARATOR

Local anesthetic

Drug: local anaesthetic injection

Extradural levobupivacaine

ACTIVE COMPARATOR

local anaesthetic

Drug: local anaesthetic injection

Extradural ropivacaine

ACTIVE COMPARATOR

local anaesthetic

Drug: local anaesthetic injection

Intrathecal bupivacaine

ACTIVE COMPARATOR

local anaesthetic

Drug: local anaesthetic injection

Intrathecal levobupivacaine

ACTIVE COMPARATOR

local anaesthetic

Drug: local anaesthetic injection

Intrathecal ropivacaine

ACTIVE COMPARATOR

local anesthetic

Drug: local anaesthetic injection

Interventions

local anaesthetic injection DRUG

Single bolus of drug for pain relief in early labour

Extradural bupivacaine; Extradural levobupivacaine; Extradural ropivacaine; Intrathecal bupivacaine; Intrathecal levobupivacaine; Intrathecal ropivacaine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Tayside: lead

Study Sites (1)

Ninewells Hospital & Medical School

Dundee, Tayside, Scotland, DD19SY, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Graeme A McLeod, MD FRCA

  NHS Tayside

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)