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Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief

Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02707081
Enrollment
150
Registered
2016-03-14
Start date
2013-06-30
Completion date
2015-12-31
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postcesarean Pain Relief

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.

Interventions

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

Patients received 00 ml of saline intraperitoneally

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

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.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Postoperative pain scoring (number)First 24 hours postoperative

Secondary

MeasureTime frame
Total pethidine consumption in 24 hours (mg)First 24 hours postoperative
The time to bowel sounds, hoursFirst 3 days postoperative
The need for rescue postoperative analgesia.First 24 hours postoperative
Duration of hospital stay , daysFirst 3 days postoperative
Any reported side effectsFirst 3 days postoperative
The time to start regular diet, daysFirst 3 days postoperative

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026