NCT02707081

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

2.5 years

First QC Date

March 4, 2016

Last Update Submit

March 8, 2016

Conditions

Postcesarean Pain Relief

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scoring (number)

    First 24 hours postoperative

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Placebo control group

PLACEBO COMPARATOR

Saline was given both intraperitoneally and intravenously during caesarean section

Drug: Intravenous normal salineDrug: Intraperitoneal normal saline

Intraperitoneal instillation group

ACTIVE COMPARATOR

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 salineDrug: Intraperitoneal Lidocaine

Intravenous injection group

ACTIVE COMPARATOR

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 salineDrug: Intravenous Lidocaine

Interventions

Intravenous normal salineDRUG

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

Also known as: IV Saline
Intraperitoneal instillation groupPlacebo control group
Intraperitoneal normal salineDRUG

Patients received 00 ml of saline intraperitoneally

Also known as: IP Saline
Intravenous injection groupPlacebo control group
Intraperitoneal LidocaineDRUG

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

Also known as: IP Lidocaine
Intraperitoneal instillation group
Intravenous LidocaineDRUG

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.

Also known as: IV Lidocaine
Intravenous injection group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy, more than or equal completed 37 gestational weeks, indicated to undergo elective cesarean delivery for various indications

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sodium ChlorideLidocaine

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 14, 2016

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 14, 2016

Record last verified: 2016-03