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

NCT04486014 | Unknown DMC

• 1 other identifier: MD.20.04.307
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Thoracic Sympathectomy

Outcome Measures

Primary Outcomes (1)

• The total analgesic consumption

  cumulative consumption of opioids during the first postoperative day

  1st 24 hours after surgery

Secondary Outcomes (13)

• Postoperative severity of the pain

  every 2 hours for 12hours and then at 16, 20 and 24 hours postoperatively

• The total amount of fentanyl consumption

  1st 24 hours after surgery

• The total amount of paracetamol consumption

  1st 24 hours after surgery

• Duration of analgesia

  within 24 hours after surgery

• Nausea

  1st 24 hours after surgery

Study Arms (2)

Erector spinae plane block (ESP)

EXPERIMENTAL

Patients would receive erector spinae plane block

Procedure: Erector spinae plane block

Serratus anterior plane block (SAP)

EXPERIMENTAL

Patients would receive serratus anterior plane block

Procedure: Serratus anterior plane block

Interventions

Erector spinae plane block PROCEDURE

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

Erector spinae plane block (ESP)

Serratus anterior plane block PROCEDURE

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

Serratus anterior plane block (SAP)

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists grade I or II physical status

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

RECRUITING

Study Officials

• Mohamed Y Makharita, MD

  Professor of Anesthesia and Surgical Intensive care,P

  STUDY CHAIR

• Doaa G Diab, MD

  Associate Professor of Anesthesia and Surgical Intensive care,

  STUDY DIRECTOR

Central Study Contacts

Mohamed Y Makharita, MD

CONTACT

00201284122800; m_younis24@yahoo.com

Doaa G Diab, MD

CONTACT

00201069507088; basmalg@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind (participant) study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 24, 2020
• Study Start: September 14, 2020
• Primary Completion: July 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 8, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after completing the study and being accepted for publication.
• Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients

Locations

EG (1)