Pectoralis and Serratus Nerves Block in Thoracic Surgery

NCT03023982 | Unknown Phase 2 DMC

• 1 other identifier: SOR 34516 CTIL
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves block) has been described for pain control after thoracic surgery, one of the indications to perform this method is analgesia for surgeries or procedures involving lateral chest wall

Conditions

Anesthesia; Surgery; Block; Thoracic Injury

Outcome Measures

Primary Outcomes (1)

• Comparison Visual Analog Score between groups

  First VAS after admission in PACU

  First 24 hours from the surgery

Secondary Outcomes (3)

• Total NSAIDs dosage (mg) in the PACU and department

  First 24 hours from the surgery

• Length of hospital stay

  up to 21 days

• Total morphine dosage (mg) in the PACU and department

  First 24 hours from the surgery

Study Arms (2)

Pectoralic block group

EXPERIMENTAL

After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.

Drug: Bupivacaine Hydrochloride; Device: Ultrasound; Procedure: Thoracotomy; Drug: Opioids; Drug: NSAID

Control group

ACTIVE COMPARATOR

Patients in this group will receive standard pain control with opioids and NSAIDs

Procedure: Thoracotomy; Drug: Opioids; Drug: NSAID

Interventions

Bupivacaine Hydrochloride DRUG

40 cc 0.25% of Bupivacaine Hydrochloride injection using ultrasound approach will be administered between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib

Also known as: Marcaine

Pectoralic block group

Ultrasound DEVICE

All blocks will be done under ultrasound

Also known as: Sonosite

Pectoralic block group

Thoracotomy PROCEDURE

The patient population will include patients that undergo either open thoracotomy or thoracoscopy for anatomic and non-anatomic lung resection. The standard thoracoscopy approach in our institute includes three holes technic. There are two incisions of 1 cm and utility incision of 4 cm. The standard thoracotomy is posterior- lateral thoracotomy which divided the latissimus dorsi muscle but spears the serratus anterior muscle.

Control group; Pectoralic block group

Opioids DRUG

standard pain control with opioids

Also known as: Morphine

Control group; Pectoralic block group

NSAID DRUG

standard pain control with NSAIDs

Also known as: Perfalgan

Control group; Pectoralic block group

Eligibility Criteria

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

You may qualify if:

• All patients undergoing thoracic surgery, older ≥18 years
• Patients who meet criteria of ASA I-II-III class.

You may not qualify if:

• Patients who will be unconscious or mentally incompetent
• Patients refusal to participate in the study
• ASA -IV -V
• Patient with coagulopathy
• Hemodynamically unstable (systolic BP \< 90, HR \> 100)
• Allergy to local anesthetic drugs or opioids
• Pregnant patient
• History of opioid abuse

Sponsors & Collaborators

• Soroka University Medical Center: lead

MeSH Terms

Conditions

Bites and Stings; Thoracic Injuries

Interventions

Bupivacaine; Ultrasonography; Thoracotomy; Analgesics, Opioid; Morphine; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Thoracic Surgical Procedures; Surgical Procedures, Operative; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 18, 2017
• Study Start: February 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 18, 2017

Record last verified: 2017-01