Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Post-Operative Pain Clinical Trial

Official title:

Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964180
• Other study ID #: analgesia LC
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: July 2021
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 20, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-Operative Pain

Intervention

Drug:
• Indomethacin suppository
two 100 mg indomethacin rectal suppositories 2 hours prior to surgery
• Lidocaine 2% Injectable Solution
200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation

Locations

Country	Name	City	State
Egypt	Gad sayed Gad	Qina	Qena

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain starting time after surgery and Pethidine required first time.	Pain starting time after surgery and Pethidine required first time.	24 hours postoperative