Erector Spinae Block Versus PECS Block Type II for Breast Surgeries

NCT04284124 | Completed

• 1 other identifier: AP2001-50504
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized, controlled prospective study is to compare the analgesic effect of US-guided ESP block versus PECs block in patients undergoing breast surgery for breast cancer in the National Cancer Institute, Cairo University. We aim to evaluate the postoperative pain intensity and opioid consumption within 24 hours

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption for 24 hours post operatively

  The primary outcome measure of the study will be total morphine consumption during the first 24 postoperative hours.

  24 hours

Secondary Outcomes (3)

• duration of analgesia

  24 hours

• post operative pain scores using numerical rating scale

  24 hours

• post operative nausea and vomiting using nausea score

  24 hours

Study Arms (2)

Erector Spinae block

ACTIVE COMPARATOR

Done unilaterally with the patient in the prone position about 20 min before induction of general anesthesia. Skin is prepared by 10% povidone iodine. An ultrasound machine with a large bandwidth, multifrequency convex probe (1-8 MHz) will be used for block performance. A 22G, 50-mm, at the T4 level of the spine using an in-plane approach. Probe is placed 2-3 cm laterally to the spine using a sagittal approach. Once the erector spinae muscle and the transverse processes is identified, the needle will be inserted deep into the muscle. The needle will be directed from a cranial to a caudal direction. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of local anesthetic, 20 ml of 0.25% bupivacaine will be administered for block performance. Distribution of local anesthetic will be observed in both cranial and caudal directions.

Other: Erector Spinae block

PECS type II block

ACTIVE COMPARATOR

Done unilaterally, patient is put in the supine position with ipsilateral arm abducted and externally rotated with elbow flexed 90 degrees. High frequency probe is put in the ipsilateral clavipectoral triangle between the clavicle medially and above and the shoulder joint laterally. The pectoralis major and minor and the plane between them are identified guided by pulsating thoracoacromial artery or its pectoral branch. Needle is advanced in plane targeting the space where the artery is located, 2ml of normal saline is injected to confirm the location. Then, 10 ml of bupivacaine 0.25% is injected. Probe is moved laterally and caudally towards the anterior axillary fold parallel to the deltopectoral groove till the serratus muscle slips appear underneath the pec minor attached to the underlying ribs. Targeting the plane between pec minor and serratus at the level of the third rib, 2 ml of normal saline is injected for confirmation of the needle tip then 20 ml of bupivacaine 0.25%.

Other: Erector Spinae block

Interventions

Erector Spinae block OTHER

Patient in the prone position 20 min before induction of general anesthesia. Skin is sterilized by 10% povidone iodine. An US multifrequency convex probe (1-8 MHz) will be used for block. A 22G, 50-mm in length needle will be used and block will be performed at the T4 level of the spine using in-plane approach where a convex probe is placed 2-3 cm lateral to the spine using sagittal approach. Erector spinae muscle and the transverse processes are located and the needle will be inserted deep into the muscle. The needle is directed craniotomy-caudally. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic to monitor spread then 20 ml of 0.25% bupivacaine will be administered for block performance. Distribution of local anesthetic is monitored in both cranial and caudal directions

Erector Spinae block; PECS type II block

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study is performed on female patients undergoing breast surgeries after diagnosis with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II
• Adult patients (\>18 years old)
• Female sex
• Scheduled for breast surgeries at NCI, CU

You may not qualify if:

• Patient's refusal of the study procedures
• Allergy to drugs used in the study
• Patients with chronic pain and chronic use of opioids
• Patients with coagulopathies (INR \> 1.6 or platelets count \< 50,000 cc3)
• Hemodynamically unstable patients (e.g. BP \< 90/60)
• Patients with local or systemic infections concerning intervention sites and septic patients

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

NCI Egypt

Cairo, 02002, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Bakir, M.D

  NCI Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, Intensive care and Pain relief

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 25, 2020
• Study Start: March 19, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

EG (1)