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

NCT04108715 | Completed DMC

• 1 other identifier: E-19-3943
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

MASTECTOMY

Outcome Measures

Primary Outcomes (10)

• Cumulative Opioid consumption in the first 24 hours.

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

  0 hours post- operative( 0 time is considered time to admission to post anesthesia care unit)

• Cumulative Opioid consumption in the first 24 hours.

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

  1 hour post-operative

• Cumulative Opioid consumption in the first 24 hours.

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

  4 hours post-operative

• Cumulative Opioid consumption in the first 24 hours.

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

  8 hours post-operative

• Cumulative Opioid consumption in the first 24 hours.

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

  24 hours post-operative

• Post-operative pain intensity

  pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

  pain at 0 hour, 0 time is considered time to admission to post anesthesia care unit

• Post-operative pain intensity

  pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

  pain at 1 hour post operative

• Post-operative pain intensity

  pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

  pain at 4 hours post operative

• Post-operative pain intensity

  pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

  pain at 8 hours post operative

• Post-operative pain intensity

  pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

  pain at 24 hours post operative

Secondary Outcomes (1)

• Time to patient mobilization

  First 24 hours post operative( 0 time is considered time to admission to post anesthesia care unit)

Study Arms (2)

ESPB GROUP

ACTIVE COMPARATOR

Erector spina plane block group

Procedure: Erector spina plain block for mastectomy analgesia

SAPB group

ACTIVE COMPARATOR

Deep Serratus anterior plane block group

Procedure: Deep serratus anterior plane block

Interventions

Erector spina plain block for mastectomy analgesia 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

ESPB GROUP

Deep serratus anterior plane block 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

SAPB group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, P.o.Box 7805, 11472, Saudi Arabia

Location

Study Officials

• Ahmed Thallaj

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor is not aware of the study type
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: September 30, 2019
• Study Start: July 7, 2019
• Primary Completion: February 2, 2020
• Study Completion: February 26, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)