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

Thoracic Sympathectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486014
• Other study ID #: MD.20.04.307
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: January 2022

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: Mohamed Y Makharita, MD
• Phone: 00201284122800
• Email: m_younis24[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Sympathectomy

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total analgesic consumption	cumulative consumption of opioids during the first postoperative day	1st 24 hours after surgery
Secondary	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
Secondary	The total amount of fentanyl consumption	cumulative consumption of fentanyl during the first postoperative day	1st 24 hours after surgery
Secondary	The total amount of paracetamol consumption	cumulative consumption of paracetamol during the first post operative day	1st 24 hours after surgery
Secondary	Duration of analgesia	from the end of block till the time for the first analgesic requirement (ketorolac)	within 24 hours after surgery
Secondary	Nausea	number of patients with nausea	1st 24 hours after surgery
Secondary	Vomiting	number of patients with vomiting	1st 24 hours after surgery
Secondary	Patient Satisfaction	evaluated as 5:excellent, 4:very good, 3:good, 2: fair, 1:poor	After 12 and 24 hours after surgery
Secondary	Heart rate	changes in heart rate	Intraoperative (every 10 minutes till the end of surgery)
Secondary	Peripheral oxygen saturation	changes in Peripheral oxygen saturation as measured with pulse oximetry	Intraoperative (every 10 minutes till the end of surgery)
Secondary	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)
Secondary	systolic blood pressure	changes in systolic blood pressure	Intraoperative (every 10 minutes till the end of surgery)
Secondary	diastolic blood pressures	changes in diastolic blood pressure	Intraoperative (every 10 minutes till the end of surgery)
Secondary	mean blood pressures	changes in mean arterial blood pressure	Intraoperative (every 10 minutes till the end of surgery)