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Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

S

South Valley University

Status

Completed

Conditions

Post-Operative Pain

Treatments

Drug: Lidocaine 2% Injectable Solution
Drug: Indomethacin suppository

Study type

Interventional

Funder types

Other

Identifiers

NCT04964180
analgesia LC

Details and patient eligibility

About

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

Enrollment

80 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

indomethacin group
Active Comparator group
Description:
group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery
Treatment:
Drug: Indomethacin suppository
intraperitoneal lidocaine
Active Comparator group
Description:
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
Treatment:
Drug: Lidocaine 2% Injectable Solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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