Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Sponsor

South Valley University (Other)

Overall Status

Completed

CT.gov ID

NCT04964180

Collaborator

(none)

Enrollment

Location

Arms

13.6

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Post-Operative Pain	Drug: Indomethacin suppository Drug: Lidocaine 2% Injectable Solution	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

May 30, 2021

Actual Study Completion Date :

Jun 20, 2021

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

VAS scores postoperative [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
postoperative opoiods analgesics requirements [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 Outcome Measures

Pain starting time after surgery and Pethidine required first time. [24 hours postoperative]
Pain starting time after surgery and Pethidine required first time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gad sayed Gad	Qinā	Qena	Egypt	83511

Sponsors and Collaborators

South Valley University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gad Sayed Gad, assisstant professor, South Valley University

ClinicalTrials.gov Identifier:

NCT04964180

Other Study ID Numbers:

analgesia LC

First Posted:

Jul 15, 2021

Last Update Posted:

Jul 15, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Indomethacin

Lidocaine

Study Results

No Results Posted as of Jul 15, 2021