Pain in early labour MedDRA version: 9.1 Level: LLT Classification code 10054891 Term: Epidural analgesia MedDRA version: 9.1 Level: LLT Classification code 10041536 Term: Spinal anaesthesia MedDRA version: 9.1 Level: LLT Classification code 10059204 Term: Labour pain
Conditions
Interventions
Trade Name: Marcain
Product Name: Bupivacaine
Pharmaceutical Form: Injection*
Trade Name: Chirocaine
Product Name: Levobupivacaine
Pharmaceutical Form: Injection*
Trade Name: Ropivacaine
Product Nam
Sponsors
NHS Tayside
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient is aged > 18 years The patient is in early labour = 5cm cervical dilitation The patient is ASA Grade I - II The patient provides written informed consent to participate in the trial prior to surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: 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 haemodynamic variables using thoracic bioimpedance To measure mode of delivery and fetal outcome ;Primary end point(s): Assessments The primary pain assessment will be the 100mm Visual Analogue Scale (VAS). The VAS will be performed pre-epidural, and at 5 minute intervals after epidural insertion for 30 minutes, and every 5 minutes for a further 15 minutes in “unsuccessful” patients as highlighted below. Three responses to epidural analgesia will be charted. Successful = 10 mm at any time within 30 min of epidural insertion Unsuccessful > 10mm at all times within 30 min of epidural insertion, but = 10 mm within 45min after rescue injection of 10ml 0.25% bupivacaine Technical failure > 10mm at all times within 30 min of epidural insertion, and still > 10 mm within 45 min despite rescue injection of 10ml 0.25% bupivacaine | — |
Countries
United Kingdom
Outcome results
None listed