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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05771116
Enrollment
70
Registered
2023-03-16
Start date
2023-01-01
Completion date
2023-07-15
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

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.

Interventions

PROCEDUREERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:

catheter will be placed for ERECTOR SPINAE PLANE BLOCK

PROCEDUREPARAVERTEBRAL BLOCK:

catheter will be placed for PARAVERTEBRAL BLOCK

Sponsors

National Cancer Institute, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

An independent observer who will be blind to the group assignment checked the intraoperative and postoperative data also patient will be be blinded also

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.48 hours postoperativethe VAS score rating, in which 0 = no pain and 10 = worst possible pain. both during rest and movement

Secondary

MeasureTime frameDescription
1st request of analgesia48 hours postoperative1st request of analgesia , any hemodynamic instability and complications

Countries

Egypt

Contacts

Primary Contactsuzan adlan, lecturer
dr_s.adlan@hotmail.com01111068300
Backup ContactTaher saed, lecturer
dr.taherthabet@gmail.com01225358877

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026