Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy

Aswan University Hospital

Status: Unknown

Conditions: Infertility

Treatments: Drug: lidocaine patches; Drug: IV lidocaine; Drug: IV saline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04506034

aswu/277/7/18

Details and patient eligibility

About

To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo.

Full description

Postoperative pain after gynecologic surgery is a challenging problem associated with increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory properties that may be beneficial in preventing ileus added to its analgesic actions. The lidocaine patch evaluated in many types of pain with promising results. The study try to evaluate the patch in perioperative field as a more simple and safe technique than the intravenous route.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female undergoing elective gynecologic surgery

Exclusion criteria

• known allergy to lidocaine,
• respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs,
• inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• hepatic, renal
• chronic use of analgesics or corticosteroids

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

lidocaine patches

Experimental group

Description:

for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.

Treatment:

Drug: lidocaine patches

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

Placebo Comparator group

Description:

received i.v. saline infusion.

Treatment:

Drug: IV saline infusion