Erector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies

Post Operative Pain Clinical Trial

Official title:

Erector Spinae Catheter Versus Paravertebral Catheter for Pain Management in Modified Radical Mastectomy for Cancer Patients: A Randomized Double-Blind Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771116
• Other study ID #: AP2212-501-034
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: February 2023
• Source: National Cancer Institute, Egypt
• Contact: suzan adlan, lecturer
• Phone: 01111068300
• Email: dr_s.adlan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups .70 patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35) - All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving general anesthesia - Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic

Description:

- 70patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35) - All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving GA - Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic. - Random numbers were generated using a computer-generated randomization code and were sealed in an opaque envelope. Randomization was conducted by a person who was not involved in the study. - An independent observer who was blind to the group assignment checked the intraoperative and postoperative data. - VAS pain score immediately postoperative and at 2,4,6, 8,12,18,24,36 ,48hrs.postoperative.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

.Physical status ASA II. . Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia Exclusion Criteria: .History of psychological disorders.

• Known sensitivity or contraindication to local anesthetics.
• Localized infection at the site of block.
• patients with coagulopathy or an (INR = 2)

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:
catheter will be placed for ERECTOR SPINAE PLANE BLOCK
• PARAVERTEBRAL BLOCK:
catheter will be placed for PARAVERTEBRAL BLOCK

Locations

Country	Name	City	State
Egypt	NCIEgypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total 48 hours Post-operative opioid consumption to keep VAS score =4.	the VAS score rating, in which 0 = "no pain" and 10 = "worst possible pain". both during rest and movement	48 hours postoperative
Secondary	1st request of analgesia	1st request of analgesia , any hemodynamic instability and complications	48 hours postoperative