Pectoralis and Serratus Nerves Block in Thoracic Surgery

NCT03023982 — Phase 2, Unknown, 168 participants, Soroka University Medical Center

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Ultrasound Guided PECs II (Pectoralis and Serratus Nerves) Block in Patients Undergoing a Thoracic Surgery

Registry	NCT03023982
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, supportive care
Enrollment	168 (Estimated)
Sponsor	Soroka University Medical Center (Other)
Conditions	Anesthesia, Surgery, Block, Thoracic Injury
Interventions	Bupivacaine Hydrochloride, Ultrasound, Thoracotomy, Opioids, NSAID (Drug, device, procedure)
Dates	start 2017-02-01, primary completion 2019-02-01 (estimated), completion 2019-02-01 (estimated), first posted 2017-01-18, last updated 2017-01-18

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Pectoralic block group	Experimental	Drug: Bupivacaine Hydrochloride; Device: Ultrasound; Procedure: Thoracotomy; Drug: Opioids; Drug: 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	Active comparator	Procedure: Thoracotomy; Drug: Opioids; Drug: NSAID	Patients in this group will receive standard pain control with opioids and NSAIDs

Bupivacaine Hydrochloride (Drug), also known as Marcaine: 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
Ultrasound (Device), also known as Sonosite: All blocks will be done under ultrasound
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.
Opioids (Drug), also known as Morphine: standard pain control with opioids
NSAID (Drug), also known as Perfalgan: standard pain control with NSAIDs

+Outcome measures

Primary outcomes

Comparison Visual Analog Score between groups [First 24 hours from the surgery]: First VAS after admission in PACU

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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