Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Hospitals, Qena, Egypt in period between May 2020 to May 2021.eighty patients was scheduled to elective laparoscopic cholecystectomy , divided Into two groups randomly using closed envelop method. Group IP lidocaine(40 patients ) received 200 ml saline containing 200 mg 2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic space, left subdiaphragmatic space and around the cholecystectomy site , all patients were maintained in trendelenberg position. At the end of the laparoscopic procedure, group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery

Official Title
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Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Conditions
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Post-Operative Pain

Intervention / Treatment
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* Drug: Indomethacin suppository
* Drug: Lidocaine 2% Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: .ASA physical status 1-2 patients. 18-60 years old . Exclusion Criteria: using or allergic to nonsteroidal anti inflammatory drugs (NSAIDs) or aspirin . history of serious hepatic disease. renal or gastrointestinal disease. bleeding disorder. body mass index BMI <18 or ˃30 m2/kg. history of abdominal surgery or chronic pain disorder other than gallbladder. disease or allergy to lidocaine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: indomethacin group<br>group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery | Drug: Indomethacin suppository<br>* two 100 mg indomethacin rectal suppositories 2 hours prior to surgery<br>* Other names: Indocid suppository;|
| Active Comparator: intraperitoneal lidocaine<br>200 ml saline containing 200 mg 2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic space, left subdiaphragmatic space and around the cholecystectomy site , all patients were maintained in trendelenberg position | Drug: Lidocaine 2% Injectable Solution<br>* 200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation<br>* Other names: lidocaine HCL 2%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS scores postoperative | a standard 10-cm VAS was used, where one end of the scale represented no pain (0 cm), and the other end the most severe pain imaginable (10 cm), the distance in centimeters being taken as the pain score | 24 hours posoperative | 
| postoperative opoiods analgesics requirements | we used (iv pethidine )whenever the patient complained of pain. IV pethidine injection 25-50 mg was given as rescue analgesic whenever the patient experienced pain ≥ to 5 VAS | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain starting time after surgery and Pethidine required first time. | Pain starting time after surgery and Pethidine required first time. | 24 hours postoperative |