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Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Primary Purpose

Post-Operative Pain

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Indomethacin suppository

Lidocaine 2% Injectable Solution

About this trial

This is an interventional prevention trial for Post-Operative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Gad sayed Gad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

indomethacin group

intraperitoneal lidocaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Pain starting time after surgery and Pethidine required first time.

Full Information

NCT ID

NCT04964180

First Posted

July 1, 2021

Last Updated

July 13, 2021

Sponsor

South Valley University

1. Study Identification

Unique Protocol Identification Number

NCT04964180

Brief Title

Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Official Title

Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

May 30, 2021 (Actual)

Study Completion Date

June 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Operative Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

indomethacin group

Arm Type

Active Comparator

Arm Description

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

Arm Title

intraperitoneal lidocaine

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Indomethacin suppository

Other Intervention Name(s)

Indocid suppository

Intervention Description

two 100 mg indomethacin rectal suppositories 2 hours prior to surgery

Intervention Type

Drug

Intervention Name(s)

Lidocaine 2% Injectable Solution

Other Intervention Name(s)

lidocaine HCL 2%

Intervention Description

200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation

Primary Outcome Measure Information:

Title

VAS scores postoperative

Description

Time Frame

24 hours posoperative

Title

postoperative opoiods analgesics requirements

Description

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

Time Frame

24 hours postoperative

Secondary Outcome Measure Information:

Title

Pain starting time after surgery and Pethidine required first time.

Description

Pain starting time after surgery and Pethidine required first time.

Time Frame

24 hours postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Gad sayed Gad

City

Qinā

State/Province

Qena

ZIP/Postal Code

83511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

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