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OpenTrials
Completed

NCT Number: NCT02707081

Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief

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.

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Key information

Conditions

Postcesarean Pain Relief

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous normal saline

Drug

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

Other names: IV Saline

Intraperitoneal normal saline

Drug

Patients received 00 ml of saline intraperitoneally

Other names: IP Saline

Intraperitoneal Lidocaine

Drug

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

Other names: IP Lidocaine

Intravenous Lidocaine

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.

Other names: IV Lidocaine

Primary outcomes

  1. Postoperative pain scoring (number)

    Time frame: First 24 hours postoperative

Secondary outcomes

  1. The need for rescue postoperative analgesia.

    Time frame: First 24 hours postoperative

  2. Total pethidine consumption in 24 hours (mg)

    Time frame: First 24 hours postoperative

  3. The time to bowel sounds, hours

    Time frame: First 3 days postoperative

  4. The time to start regular diet, days

    Time frame: First 3 days postoperative

  5. Duration of hospital stay , days

    Time frame: First 3 days postoperative

  6. Any reported side effects

    Time frame: First 3 days postoperative

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 14, 2016
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.