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

Not Applicable

Recruiting

• Conditions: Post Operative Pain

• Registration Number: NCT05771116
• Lead Sponsor: National Cancer Institute, Egypt

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-04
• Study First Posted: 2023-03-16
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.	48 hours postoperative	the VAS score rating, in which 0 = "no pain" and 10 = "worst possible pain". both during rest and movement

Secondary Outcome Measures

Name	Time	Method
1st request of analgesia	48 hours postoperative	1st request of analgesia , any hemodynamic instability and complications

Trial Locations

Locations (1)

NCIEgypt; 🇪🇬 Cairo, Egypt