Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief
Phase 2
Completed
- Conditions
- Postcesarean Pain Relief
- Interventions
- Drug: Intravenous normal salineDrug: Intraperitoneal normal saline
- Registration Number
- NCT02707081
- Lead Sponsor
- Benha University
- Brief Summary
Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV) lidocaine infusion for postoperative pain control after cesarean section.
Study design: prospective randomized, double-blind, placebo-controlled study. Patients and methods: Initially, 165 pregnant full-term females, indicated to be underwent elective cesarean delivery for various indications were randomized equally to either group C (control, IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV (intravenous lidocaine infusion).Five patients were excluded from each group for various reasons. The outcome measures were postoperative pain scoring, total pethidine consumption and the need for postoperative analgesia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
- Singleton pregnancy, more than or equal completed 37 gestational weeks, indicated to undergo elective cesarean delivery for various indications
Exclusion Criteria
- extreme of age (below 18 or above 40 year), uncooperative patients, women under spinal anesthesia, previous abdominal scars, including previous cesarean or myomectomy, multiple gestation, BMI >35 kg/m², chorioamnionitis, hypersensitivity or contraindications to lidocaine, bronchial asthma, bleeding diathesis, pregnancy induced-hypertension, liver or kidney diseases, diabetes mellitus, and patients with psychological disturbance, or any form of chronic pain before or during pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous injection group Intravenous Lidocaine Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding Intraperitoneal instillation group Intravenous normal saline Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure with intravenous normal saline in a volume equivalent to that used in intravenous lidocaine group as placebo to ensure blinding. Intraperitoneal instillation group Intraperitoneal Lidocaine Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure with intravenous normal saline in a volume equivalent to that used in intravenous lidocaine group as placebo to ensure blinding. Intravenous injection group Intraperitoneal normal saline Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding Placebo control group Intraperitoneal normal saline Saline was given both intraperitoneally and intravenously during caesarean section Placebo control group Intravenous normal saline Saline was given both intraperitoneally and intravenously during caesarean section
- Primary Outcome Measures
Name Time Method Postoperative pain scoring (number) First 24 hours postoperative
- Secondary Outcome Measures
Name Time Method The need for rescue postoperative analgesia. First 24 hours postoperative Total pethidine consumption in 24 hours (mg) First 24 hours postoperative The time to bowel sounds, hours First 3 days postoperative The time to start regular diet, days First 3 days postoperative Duration of hospital stay , days First 3 days postoperative Any reported side effects First 3 days postoperative