Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief

Conditions
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Postcesarean Pain Relief

Intervention / Treatment
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* Drug: Intravenous normal saline
* Drug: Intraperitoneal normal saline
* Drug: Intraperitoneal Lidocaine
* Drug: Intravenous Lidocaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo control group<br>Saline was given both intraperitoneally and intravenously during caesarean section | Drug: Intravenous normal saline<br>* Normal saline in a volume equivalent to that used in intravenous lidocaine group<br>* Other names: IV Saline;Drug: Intraperitoneal normal saline<br>* Patients received 00 ml of saline intraperitoneally<br>* Other names: IP Saline;|
| Active Comparator: Intraperitoneal instillation group<br>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. | Drug: Intravenous normal saline<br>* Normal saline in a volume equivalent to that used in intravenous lidocaine group<br>* Other names: IV Saline;Drug: Intraperitoneal Lidocaine<br>* Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure.<br>* Other names: IP Lidocaine;|
| Active Comparator: Intravenous injection group<br>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 | Drug: Intraperitoneal normal saline<br>* Patients received 00 ml of saline intraperitoneally<br>* Other names: IP Saline;Drug: Intravenous Lidocaine<br>* 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.<br>* Other names: IV Lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scoring (number) |  | First 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |