Clinical trial NCT04486014: Analgesic Effect of Erector Spinae Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Sympathectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The total analgesic consumption
timeFrame: 1st 24 hours after surgery
Secondary outcomes:
measure: Postoperative severity of the pain
timeFrame: every 2 hours for 12hours and then at 16, 20 and 24 hours postoperatively
measure: The total amount of fentanyl consumption
timeFrame: 1st 24 hours after surgery
measure: The total amount of paracetamol consumption
timeFrame: 1st 24 hours after surgery
measure: Duration of analgesia
timeFrame: within 24 hours after surgery
measure: Nausea
timeFrame: 1st 24 hours after surgery
measure: Vomiting
timeFrame: 1st 24 hours after surgery
measure: Patient Satisfaction
timeFrame: After 12 and 24 hours after surgery
measure: Heart rate
timeFrame: Intraoperative (every 10 minutes till the end of surgery)
measure: Peripheral oxygen saturation
timeFrame: Intraoperative (every 10 minutes till the end of surgery)
measure: End-tidal carbon dioxide tension
timeFrame: Intraoperative (every 10 minutes till the end of surgery)
measure: systolic blood pressure
timeFrame: Intraoperative (every 10 minutes till the end of surgery)
measure: diastolic blood pressures
timeFrame: Intraoperative (every 10 minutes till the end of surgery)
measure: mean blood pressures
timeFrame: Intraoperative (every 10 minutes till the end of surgery)
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive care,P
name: Mohamed Y Makharita, MD
role: STUDY_CHAIR
affiliation: Associate Professor of Anesthesia and Surgical Intensive care,
name: Doaa G Diab, MD
role: STUDY_DIRECTOR
References: