Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section

Aswan University Hospital

Status: Unknown

Conditions: Cesarean Section Complications

Treatments: Drug: lidocaine patch; Drug: IV lidocaine; Drug: IV saline infusion +Sham patch

Study type: Interventional

Funder types: Other

Identifiers

NCT04505644

aswu/279/6/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

lidocaine patch

Experimental group

Description:

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.

Treatment:

Drug: lidocaine patch

IV lidocaine

Active Comparator group

Description:

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.

Treatment:

Drug: IV lidocaine

IV saline infusion +Sham patch

Placebo Comparator group

Description:

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.

Treatment:

Drug: IV saline infusion +Sham patch