Analgesic Effect of Erector Spinae Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy

A Comparative Study of the Analgesic Effect of Ultrasound-guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy Surgeries

• Thoracic incisions are painful and associated with chronic post-surgical pain and inadequate analgesia is associated with poorer postoperative outcomes. Recent progress has been made in the field of thoracic anesthesia by improving analgesic modalities such as PECS 1 and PECS 2, intercostal plane block, paravertebral regional anesthesia, ultrasound-guided erector spinae and serratus anterior plane block.
• Administered of the local anesthetic in erector spinae plane block is in the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces. It affects both the ventral and dorsal rami and leading to blockage of both visceral and somatic pain.
• Ultrasound-guided serratus anterior plane block is a facial plane block that provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle.
• We hypothesize that the ultrasound-guided erector spinae plane block may have better quality than the serratus anterior plane block for patients undergoing thoracoscopic sympathectomy as erector spinea plane blocks visceral and somatic pain.

Study Overview

• Status: Unknown
• Conditions: Thoracic Sympathectomy
• Intervention / Treatment: Procedure: Erector spinae plane block; Procedure: Serratus anterior plane block

Detailed Description

Primary palmar hyperhidrosis (PPH) refers to the excessive secretion of exocrine glands on the palms, which is often accompanied by the head, face, or plantar hyperhidrosis. PPH demonstrates no obvious organic cause; however, some patients may feel distressed because their palms sweat more than normal, and such a situation may lead to severe psychological, social, and occupational dysfunction.

Endoscopic thoracic sympathectomy abolishes eccrine sweating in all areas supplied by the postganglionic fibers with its complications which include post-sympathetic neuralgia which is the most important, wound infection, hemorrhage, pneumothorax, horner syndrome, no response to the operation and compensatory hyperhidrosis in non-denervated areas.

Forero described ultrasound-guided erector spinae plane block for treatment of thoracic neuropathic pain and explained it as a peri-paravertebral regional anesthesia technique that has been used for prevention of postoperative pain in various surgeries.

Ultrasound-guided serratus anterior plane block is a facial plane block which provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by serratus anterior plane block

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Recruiting
      • Mansoura University
      • Contact: Mohamed Y Makharita, MD; Phone Number: 00201284122800; Email: m_younis24@yahoo.com
      • Sub-Investigator: Ahmed M Abozeid, MD
      • Principal Investigator: Mohamed Y Abd-alla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists grade I or II physical status

Exclusion Criteria:

• Patients who had coagulopathies
• local infections
• neuropathies
• neuromuscular disease
• psychiatric disease
• history of thoracic surgery
• history of allergy to local anesthetics.
• receiving chronic analgesic therapy
• drug abusers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Erector spinae plane block (ESP); Patients would receive erector spinae plane block	Procedure: Erector spinae plane block; Erector Spinae Group (Group E) will receive bilateral ultrasound-guided erector spinae plane block using 30 ml hyperbaric bupivacaine 0.25% will be injected between erector spinae muscle and transverse process of T4
EXPERIMENTAL: Serratus anterior plane block (SAP); Patients would receive serratus anterior plane block	Procedure: Serratus anterior plane block; Serratus anterior Group (Group S) will undergo bilateral ultrasound-guided serratus anterior plane block with 30 ml hyperbaric bupivacaine 0.25% will be injected above or below serratus anterior muscle at the level of 4th and 5th rib on the midaxillary line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total analgesic consumption	cumulative consumption of opioids during the first postoperative day	1st 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative severity of the pain	Visual analogue scale (0-100),where 0 point is equal to no pain and 100 indicate the worst possible pain	every 2 hours for 12hours and then at 16, 20 and 24 hours postoperatively
The total amount of fentanyl consumption	cumulative consumption of fentanyl during the first postoperative day	1st 24 hours after surgery
The total amount of paracetamol consumption	cumulative consumption of paracetamol during the first post operative day	1st 24 hours after surgery
Duration of analgesia	from the end of block till the time for the first analgesic requirement (ketorolac)	within 24 hours after surgery
Nausea	number of patients with nausea	1st 24 hours after surgery
Vomiting	number of patients with vomiting	1st 24 hours after surgery
Patient Satisfaction	evaluated as 5:excellent, 4:very good, 3:good, 2: fair, 1:poor	After 12 and 24 hours after surgery
Heart rate	changes in heart rate	Intraoperative (every 10 minutes till the end of surgery)
Peripheral oxygen saturation	changes in Peripheral oxygen saturation as measured with pulse oximetry	Intraoperative (every 10 minutes till the end of surgery)
End-tidal carbon dioxide tension	changes in end-tidal carbon dioxide tension as measured with capnography	Intraoperative (every 10 minutes till the end of surgery)
systolic blood pressure	changes in systolic blood pressure	Intraoperative (every 10 minutes till the end of surgery)
diastolic blood pressures	changes in diastolic blood pressure	Intraoperative (every 10 minutes till the end of surgery)
mean blood pressures	changes in mean arterial blood pressure	Intraoperative (every 10 minutes till the end of surgery)

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mohamed Y Makharita, MD, Professor of Anesthesia and Surgical Intensive care,P; Study Director: Doaa G Diab, MD, Associate Professor of Anesthesia and Surgical Intensive care,

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (ACTUAL): July 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MD.20.04.307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
• IPD Sharing Time Frame: after completing the study and being accepted for publication.
• IPD Sharing Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No