NCT04505644

Brief Summary

To evaluate the efficacy of lidocaine patch applied around wound in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo after cesarean section.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

August 6, 2020

Last Update Submit

August 7, 2020

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (2)

  • Total dose of opioids received in the first 24 hours following Cesarean

    The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.

    24 hours

  • Post-operative pain score at 24 hours post-operatively

    Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores

    24 hours

Secondary Outcomes (2)

  • Incidence of complications of lidocaine use

    72 hours

  • Return of bowel function

    72 hours

Study Arms (3)

lidocaine patch

EXPERIMENTAL

5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Drug: lidocaine patch

IV lidocaine

ACTIVE COMPARATOR

received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight \>70 kg or 1 mg/min if body weight \<70 kg.

Drug: IV lidocaine

IV saline infusion +Sham patch

PLACEBO COMPARATOR

received i.v. saline infusion +Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Drug: IV saline infusion +Sham patch

Interventions

lidocaine patchDRUG

Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Also known as: ;lidocaine patch
lidocaine patch
IV lidocaineDRUG

received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight \>70 kg or 1 mg/min if body weight \<70 kg.

IV lidocaine
IV saline infusion +Sham patchDRUG

received i.v. saline infusion +Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Also known as: placebo
IV saline infusion +Sham patch

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients need to be pregnant and undergoing a cesarean delivery
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Primary or secondary cesarean delivery
  • Able to consent to research study

You may not qualify if:

  • or more prior cesarean deliveries
  • History of abdominoplasty
  • History of abdominal hernia repair with mesh
  • Allergy to lidocaine
  • Allergy to adhesives in medical tape
  • Women who received general anesthesia for their cesarean delivery
  • Women with active substance abuse
  • Women methadone or suboxone for a history of opiate abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • nahla w Shady, md

    Aswan universirty

    STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461hany.farouk@aswu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind randomized controlled study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: double blind randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Professor

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

September 1, 2020

Primary Completion

March 30, 2021

Study Completion

May 30, 2021

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)