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

Status:

Completed

Sponsors

King Saud University

Abstract:

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.

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.

Last Verified:	January/31/2020
First Submitted:	July/6/2019
Estimated Enrollment Submitted:	September/26/2019
First Posted:	September/29/2019
Last Update Submitted:	February/28/2020
Last Update Posted:	March/2/2020
Actual Study Start Date:	July/6/2019
Estimated Primary Completion Date:	February/1/2020
Estimated Study Completion Date:	February/25/2020

Condition or disease:MASTECTOMY

Intervention/treatment:

Procedure: ESPB GROUP

Procedure: SAPB group

Phase:-

Study design:

Study Type:	Interventional
Allocation:	Randomized
Primary Purpose:	Treatment
Masking:	Single (Outcomes Assessor)
:	The outcome assessor is not aware of the study type

Arm group:

Arm	Intervention/treatment
Active Comparator: ESPB GROUP Erector spina plane block group	Procedure: ESPB GROUP 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
Active Comparator: SAPB group Deep Serratus anterior plane block group	Procedure: SAPB group 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

Arm

Intervention/treatment

Active Comparator: ESPB GROUP

Erector spina plane block group

Procedure: ESPB GROUP

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

Active Comparator: SAPB group

Deep Serratus anterior plane block group

Procedure: SAPB group

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

Eligibility Criteria:

Ages Eligible for Study:	18 Years to 18 Years
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
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

Outcome:

Primary Outcome Measures

1. Cumulative Opioid consumption in the first 24 hours. [0 hours post- operative( 0 time is considered time to admission to post anesthesia care unit)]

Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

2. Cumulative Opioid consumption in the first 24 hours. [1 hour post-operative]

Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

3. Cumulative Opioid consumption in the first 24 hours. [4 hours post-operative]

Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

4. Cumulative Opioid consumption in the first 24 hours. [8 hours post-operative]

Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

5. Cumulative Opioid consumption in the first 24 hours. [24 hours post-operative]

Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

6. Post-operative pain intensity [pain at 0 hour, 0 time is considered time to admission to post anesthesia care unit]