Infertility
Conditions
Brief summary
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.
Detailed 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.
Interventions
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.
DRUGIV 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.
received i.v. saline infusion.
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
randomized controlled trial
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain VAS scores at rest and during coughing were recorded postoperatively | 24 hours | To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=no pain and 100=the worst pain you have ever felt. |
Countries
Egypt
Contacts
Primary Contacthany f Sallam, md
Backup Contactnahla w Shady, md
Outcome results
None listed