Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-06-20

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

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Detailed Description

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Conditions

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Post-Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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indomethacin group

group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery

Group Type ACTIVE_COMPARATOR

Indomethacin suppository

Intervention Type DRUG

two 100 mg indomethacin rectal suppositories 2 hours prior to surgery

intraperitoneal lidocaine

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

Group Type ACTIVE_COMPARATOR

Lidocaine 2% Injectable Solution

Intervention Type DRUG

200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation

Interventions

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Indomethacin suppository

two 100 mg indomethacin rectal suppositories 2 hours prior to surgery

Intervention Type DRUG

Lidocaine 2% Injectable Solution

200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation

Intervention Type DRUG

Other Intervention Names

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Indocid suppository lidocaine HCL 2%

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No