Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section

NCT ID: NCT04505644

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-05-30

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.

Detailed Description

The use of lidocaine as a local anesthetic is a common and widely used in practice. Lidocaine patches can be used for localized pain control and can be placed every 24 hours. The use of lidocaine patches in post-operative patients has been reported in one case report in obstetric literature. There is one study that reports decreased immediate postoperative pain when lidocaine patches were placed at laparoscopic port sites following gynecologic surgery as measured by visual analog scale score and the Prince Henry and 5-point verbal rating pain scale . There have been no studies looking at the impact of lidocaine patches in obstetric surgical procedures, specifically cesarean sections.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

lidocaine patch

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.

Group Type: EXPERIMENTAL

lidocaine patch

Intervention Type: DRUG

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.

IV lidocaine

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.

Group Type: ACTIVE_COMPARATOR

IV lidocaine

Intervention Type: DRUG

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 saline infusion +Sham patch

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.

Group Type: PLACEBO_COMPARATOR

IV saline infusion +Sham patch

Intervention Type: DRUG

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.

Interventions

lidocaine patch

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.

Intervention Type: DRUG

IV lidocaine

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.

Intervention Type: DRUG

IV saline infusion +Sham patch

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.

Intervention Type: DRUG

Other Intervention Names

;lidocaine patch; placebo

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 3 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

A Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

Aswan University Hospital

Aswān, , Egypt

Countries

Egypt

Central Contacts

hany f Sallam, md

Role: CONTACT

hany.farouk@aswu.edu.eg

+20102435461 ext. 002

Other Identifiers

aswu/279/6/18

Identifier Type: -

Identifier Source: org_study_id