Pectoralis and Serratus Nerves Block in Thoracic Surgery

Phase 2

• Conditions: Surgery; Anesthesia; Block; Thoracic Injury
• Interventions: Drug: Bupivacaine Hydrochloride; Device: Ultrasound; Procedure: Thoracotomy; Drug: Opioids; Drug: NSAID

• Registration Number: NCT03023982
• Lead Sponsor: Soroka University Medical Center

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

Detailed Description

The PECs I block was found to be very effective after breast cancer surgery and sub-pectoral prosthesis for pain control management.

This block is provided by injection into another myofascial plane, this time between pectoralis minor and serratus anterior muscle at the level of 3rd and 4th rib.PECs II block is simple in performance with a high success rate and minimal incidence of complications, especially, if used ultrasound approach that gives a good understanding of anatomy of the lateral thoracic wall.

In present clinical trial we are going to compare PECs block for pain control with traditional pain management techniques based on IV opioids and NSAIDs treatment in patient undergoing thoracic surgery in early postoperative period.

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-17
• Last Update Submitted: 2017-01-17
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-18
• Study Start: 2017-02
• Primary Completion: 2019-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pectoralic block group	Thoracotomy	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.
Pectoralic block group	Opioids	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.
Control group	Opioids	Patients in this group will receive standard pain control with opioids and NSAIDs
Pectoralic block group	Ultrasound	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.
Control group	Thoracotomy	Patients in this group will receive standard pain control with opioids and NSAIDs
Pectoralic block group	NSAID	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.
Control group	NSAID	Patients in this group will receive standard pain control with opioids and NSAIDs
Pectoralic block group	Bupivacaine Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Comparison Visual Analog Score between groups	First 24 hours from the surgery	First VAS after admission in PACU

Secondary Outcome Measures

Name	Time	Method
Total NSAIDs dosage (mg) in the PACU and department	First 24 hours from the surgery	While the patient is in PACU
Length of hospital stay	up to 21 days	Measuring time of at discharge from hospital
Total morphine dosage (mg) in the PACU and department	First 24 hours from the surgery	While the patient is in PACU