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OpenTrials
Completed

NCT Number: NCT04964180

Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

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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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gad sayed Gad

Qina, Qena Governorate, 83511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indomethacin suppository

Drug

two 100 mg indomethacin rectal suppositories 2 hours prior to surgery

Other names: Indocid suppository

Lidocaine 2% Injectable Solution

Drug

200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation

Other names: lidocaine HCL 2%

Primary outcomes

  1. VAS scores postoperative

    Time frame: 24 hours posoperative

    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

  2. postoperative opoiods analgesics requirements

    Time frame: 24 hours postoperative

    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

Secondary outcomes

  1. Pain starting time after surgery and Pethidine required first time.

    Time frame: 24 hours postoperative

    Pain starting time after surgery and Pethidine required first time.

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Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2021
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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