Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief

Benha University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postcesarean Pain Relief

Treatments: Drug: Intraperitoneal normal saline; Drug: Intravenous normal saline; Drug: Intravenous Lidocaine; Drug: Intraperitoneal Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02707081

Benha 121

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Placebo control group

Placebo Comparator group

Description:

Saline was given both intraperitoneally and intravenously during caesarean section

Treatment:

Drug: Intraperitoneal normal saline

Drug: Intravenous normal saline

Intraperitoneal instillation group

Active Comparator group

Description:

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.

Treatment:

Drug: Intraperitoneal Lidocaine

Drug: Intravenous normal saline

Intravenous injection group

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Lidocaine

Drug: Intraperitoneal normal saline