ignocaine for the prevention of chronic pain after caesarean sectio

Phase 1

Recruiting

• Conditions: pregnancy; postoperative pain; chronic pain; caesarean section; Anaesthesiology - Pain management; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12620000203954
• Lead Sponsor: Royal Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

Pregnant people. Age 18 years or greater, age 50 years or less; Gestational age 36 weeks; or greater Undergoing elective caesarean section surgery under neuraxial anaesthesia (spinal anaesthesia); Weight (on day of caesarean section surgery) 50 kg or greater, 120 kg or less

Exclusion Criteria

American Society of Anesthesiology (ASA) class III, IV; Preoperative opioid therapy in the seven days prior to surgery; History of recreational drug use in the last 12 months prior to surgery; Allergies to local anaesthetics, morphine, fentanyl, paracetamol; Allergy or adverse reaction to non-steroidal anti-inflammatory drugs (NSAIDs); Body mass index (on day of caesarean section surgery) 45 kg/m¬2 or less.; Renal or liver impairment; Placental adhesive disorder defined on ultrasound and/or MRI; Known uterine fibroids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence (proportion (standard deviation and 95% confidence interval)) of chronic postsurgical pain (CPSP) at three months in women undergoing elective caesarean section surgery in the control/placebo group <br>[ Measured at 3 months after caesarean section surgery using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale];The proportion of eligible participants who agree to be part of the study [ At three months after study commencement study records will be reviewed to assess the proportion of eligible participants who agreed to being part of the study ];The number and proportion of participants who are followed-up at the three month review[ Six months after study commencement study records will be reviewed to assess the number and proportion of participants who were followed-up at the three month review]

Secondary Outcome Measures

Name	Time	Method
Maternal plasma lignocaine concentration within one hour of cessation of intravenous infusion [ Within one hour of cessation of intravenous infusion- Measured from a venous blood sample collected at that time and sent to specialist laboratory ];Neonatal (umbilical vein and artery) plasma lignocaine concentration immediately after birth[ Within 5 minutes of birth measured from a venous and arterial umbilical cord blood sample collected at that time and sent to specialist laboratory ];The number of participants who adhere to the randomised controlled trial (RCT) protocol [ Measured at 3 months are recruitment by examining study records documenting protocol adherence or non-adherence ];The average time (in minutes) it takes to perform the follow-up consultation[ Measured at the time of follow-up consultation using a timer activated at the start of the consultation and deactivated at the end of the consultation]