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

Study Overview

• Status: Completed
• Conditions: Post-Operative Pain
• Intervention / Treatment: Drug: Indomethacin suppository; Drug: Lidocaine 2% Injectable Solution

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qena
    • Qinā, Qena, Egypt, 83511
      • Gad sayed Gad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: indomethacin group; group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery	Drug: Indomethacin suppository; two 100 mg indomethacin rectal suppositories 2 hours prior to surgery; Other Names: Indocid suppository
Active Comparator: 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	Drug: Lidocaine 2% Injectable Solution; 200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation; Other Names: lidocaine HCL 2%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Lidocaine; Indomethacin
• Other Study ID Numbers: analgesia LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No