Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia

NCT ID: NCT04108715

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-07
• Study Completion Date: 2020-02-26

Brief Summary

Breast cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Respiratory depression, Ileus, sedation, nausea and vomiting are some of the potential side effect of opioid treatment which prolonged hospital length of stay and increase the coast. Recent advance in ultrasound guided regional anesthesia has led to the development of two novel regional anesthesia techniques specific to chest wall analgesia; Erector spina plain block and Serratus anterior plain block, with its potential to reduce or eliminate the need for opioids to manage post-operative pain.

Detailed Description

Experimental: erector spinae plain block After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, and prepping para-spinous area with antiseptic solution. Ultrasound high frequency linear transducer is positioned in a para-sagittal plane at the level of fifth thoracic vertebra. Scanning of interested structures from superficial to deep planes, Trapezius muscle, Rhomboid major muscle, Erector spina muscle and transverse process of fifth thoracic vertebra.

Comparator: serratus anterior plane block After giving general anesthesia, patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. Under sterile aseptic technique, a linear ultrasound transducer (6-15 MHz) is placed in a sagittal oblique plane over the fourth and fifth ribs at the mid-axillary line. The following muscles are identified overlying the fourth/ fifth rib: the latissimus dorsi (superficial) and serratus anterior muscle (deep) overlying the ribs.

Conditions

MASTECTOMY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESPB GROUP

Erector spina plane block group

Group Type: ACTIVE_COMPARATOR

Erector spina plain block for mastectomy analgesia

Intervention Type: PROCEDURE

After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, An erector Spina plain block is performed with inserting block needle (Pajunk, Geisingen, Germany) in-plane under ultrasound control until needle tip hits the transverse process, a volume of 0.3 ml/kg of bupivacaine 0.25% (Marcaine, Astra Zeneca Pharmaceuticals) is injected. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia (PCA) for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10) and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to post-anesthesia care unit PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented

SAPB group

Deep Serratus anterior plane block group

Group Type: ACTIVE_COMPARATOR

Deep serratus anterior plane block

Intervention Type: PROCEDURE

After giving general anesthesia, the patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. A block needle is introduced in-plane, targeting the plane deep to the serratus anterior muscle, and a bolus of 0.3 ml/kg bupivacaine 0.25% is injected through ultrasound guidance. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia PCA for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10), and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented

Interventions

Erector spina plain block for mastectomy analgesia

After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, An erector Spina plain block is performed with inserting block needle (Pajunk, Geisingen, Germany) in-plane under ultrasound control until needle tip hits the transverse process, a volume of 0.3 ml/kg of bupivacaine 0.25% (Marcaine, Astra Zeneca Pharmaceuticals) is injected. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia (PCA) for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10) and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to post-anesthesia care unit PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented

Intervention Type: PROCEDURE

Deep serratus anterior plane block

After giving general anesthesia, the patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. A block needle is introduced in-plane, targeting the plane deep to the serratus anterior muscle, and a bolus of 0.3 ml/kg bupivacaine 0.25% is injected through ultrasound guidance. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia PCA for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10), and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ASA I-III patients age 18 to 75 years undergoing unilateral breast surgery

Exclusion Criteria

• Patients refusal
• History of amide local anesthetics allergy
• Alcohol or drug abuse
• Chronic opioid intake
• Language barriers
• Patient with psychiatric disorders
• Contraindications for regional anesthesia
• BMI > 40 Kg/m2
• Obstructive sleep apnea that preclude PCA opioids

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Khaled Thallaj

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Thallaj

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Locations

King Saud University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

E-19-3943

Identifier Type: -

Identifier Source: org_study_id