Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

NCT04964180 | Completed

• 1 other identifier: analgesia LC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-Operative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  24 hours postoperative

Study Arms (2)

indomethacin group

ACTIVE COMPARATOR

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

Drug: Indomethacin suppository

intraperitoneal lidocaine

ACTIVE COMPARATOR

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

Interventions

Indomethacin suppository DRUG

two 100 mg indomethacin rectal suppositories 2 hours prior to surgery

Also known as: Indocid suppository

indomethacin group

Lidocaine 2% Injectable Solution DRUG

200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation

Also known as: lidocaine HCL 2%

intraperitoneal lidocaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status 1-2 patients.
• years old .

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Gad sayed Gad

Qina, Qena Governorate, 83511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant professor

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 15, 2021
• Study Start: May 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: June 20, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

EG (1)