Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Cesarean Section? A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04505644
• Other study ID #: aswu/279/6/18
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: August 2020
• Source: Aswan University Hospital
• Contact: hany f Sallam, md
• Phone: +20102435461
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: May 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incidence of complications of lidocaine use	Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.; Definition: Patient reported side effects which will be reported as frequencies of occurrence	72 hours
Secondary	Return of bowel function	Return of bowel function (measured in hours from completion of surgery to passage of flatus) Measured in hours from completion of surgery to passage of flatus. This will be reported as a continuous variable for the number of hours following surgery to flatus	72 hours