Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief

NCT ID: NCT02707081

Last Updated: 2016-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

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.

Detailed Description

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Conditions

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Postcesarean Pain Relief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo control group

Saline was given both intraperitoneally and intravenously during caesarean section

Group Type PLACEBO_COMPARATOR

Intravenous normal saline

Intervention Type DRUG

Normal saline in a volume equivalent to that used in intravenous lidocaine group

Intraperitoneal normal saline

Intervention Type DRUG

Patients received 00 ml of saline intraperitoneally

Intraperitoneal instillation group

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.

Group Type ACTIVE_COMPARATOR

Intravenous normal saline

Intervention Type DRUG

Normal saline in a volume equivalent to that used in intravenous lidocaine group

Intraperitoneal Lidocaine

Intervention Type DRUG

Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure.

Intravenous injection group

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

Group Type ACTIVE_COMPARATOR

Intraperitoneal normal saline

Intervention Type DRUG

Patients received 00 ml of saline intraperitoneally

Intravenous Lidocaine

Intervention Type DRUG

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.

Interventions

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Intravenous normal saline

Normal saline in a volume equivalent to that used in intravenous lidocaine group

Intervention Type DRUG

Intraperitoneal normal saline

Patients received 00 ml of saline intraperitoneally

Intervention Type DRUG

Intraperitoneal Lidocaine

Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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IV Saline IP Saline IP Lidocaine IV Lidocaine

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Walid Anwar Murad

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Benha 121

Identifier Type: -

Identifier Source: org_study_id

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