Comparaison of ESP Block and TAP Block

Post Operative Pain Clinical Trial

Official title:

ESP Versus TAP for Analgesia After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04176770
• Other study ID #: ESP in cholecystectomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2019
• Source: Mongi Slim Hospital
• Contact: Mhamed Sami Mebazaa, professor
• Phone: 0021622252589
• Email: msmebazaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aim to compare the efficiency and the analgesic effect of Erector Spinal Plane Block versus TAP Block after laparoscopic cholecystectomy.

Description:

This study will include patients scheduled for laparoscopic cholecystectomy, ASA status 1 or

2. patients will be randomized in 2 groups to recieve post operative analgesia with -ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.

or

-TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adult patients

• ASA status I or II

• scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

• laparotomy

• unplanned ICU admission

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• ESP Block
ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.
• TAP Block
TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%

Locations

Country	Name	City	State
Tunisia	Mongi Slim Hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative analgesia	Post operative analgesia assessed with Numerical rating scale (0=minimum, 10= Maximum)	24 hours after intervention
Secondary	post operative analgesic consumption	Amount of Morphin needed for analgesia	24 hours after intervention