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

NCT05771116 | Unknown

• 1 other identifier: AP2212-501-034
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 1st request of analgesia

  48 hours postoperative

Study Arms (2)

Erecto Spinae Plane Block group

ACTIVE COMPARATOR

a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The skin will be anaesthetized using 3ml of 2% Lidocaine. A 20-gauge block needle will be inserted in-plane in a cephalad-to-caudad direction to place the tip into the fascial plane on the deep (anterior) aspect of erector spinaemuscle;20ml bupivacaine 0.25% will be injected. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process The needle will be removed and the catheter secured with adhesive.

Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:; Procedure: PARAVERTEBRAL BLOCK:

the paravertebral group

ACTIVE COMPARATOR

After identification of the transverse process, internal intercostal membrane (IIM), and pleura at the T3 and T6 levels, an out-of-plane needle guidance technique was used to perform the PVB.The success of both blocks will be confirmed by loss of pinprick sensation on the dermatomal site of the block •blocks will be activated ,After negative aspiration, 0.5 ml/kg 0.25% bupivacaine (max 20 ml) will be injected. Afterwards, a 20 gauge peripheral nerve catheter will be easily threaded into the space. The needle will be removed and the catheter secured with adhesive.

Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:; Procedure: PARAVERTEBRAL BLOCK:

Interventions

ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK: PROCEDURE

catheter will be placed for ERECTOR SPINAE PLANE BLOCK

Erecto Spinae Plane Block group; the paravertebral group

PARAVERTEBRAL BLOCK: PROCEDURE

catheter will be placed for PARAVERTEBRAL BLOCK

Erecto Spinae Plane Block group; the paravertebral group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: female post mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical status ASA II.
• Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

NCIEgypt

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• suzan adlan, lecturer

  National Cancer Institute, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

suzan adlan, lecturer

CONTACT

01111068300; dr_s.adlan@hotmail.com

Taher saed, lecturer

CONTACT

01225358877; dr.taherthabet@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: An independent observer who will be blind to the group assignment checked the intraoperative and postoperative data also patient will be be blinded also
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 16, 2023
• Study Start: January 1, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)