Back to resultsLidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lidocaine patches
IV lidocaine
IV saline infusion
Sponsored by
About this trial
This is an interventional prevention trial for Infertility
Eligibility Criteria
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
Sites / Locations
- Aswan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
lidocaine patches
IV lidocaine
IV saline infusion
Arm 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.
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.
Outcomes
Primary Outcome Measures
Pain VAS scores at rest and during coughing were recorded postoperatively
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT04506034
First Posted
August 6, 2020
Last Updated
August 7, 2020
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04506034
Brief Title
Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy
Official Title
Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Laparoscopic Gynecologic Surgery? A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Participant
Masking Description
randomized controlled trial
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lidocaine patches
Arm Type
Experimental
Arm 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.
Arm Title
IV lidocaine
Arm Type
Active Comparator
Arm 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.
Arm Title
IV saline infusion
Arm Type
Placebo Comparator
Arm Description
received i.v. saline infusion.
Intervention Type
Drug
Intervention Name(s)
lidocaine patches
Other Intervention Name(s)
lidocaine patch
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
IV lidocaine
Other Intervention Name(s)
lidocaine infusion
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
IV saline infusion
Other Intervention Name(s)
placebo
Intervention Description
received i.v. saline infusion.
Primary Outcome Measure Information:
Title
Pain VAS scores at rest and during coughing were recorded postoperatively
Description
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".
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female for laparoscopic gynecology
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f Sallam, md
Phone
+20102435461
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
nahla w Shady, md
Phone
+201022336052
Ext
002
Email
hanygyne@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nahla w Shady, md
Organizational Affiliation
Aswan universirty
Official's Role
Study Chair
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy
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