Pectoralis and Serratus Nerves Block in Thoracic Surgery

NCT ID: NCT03023982

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2019-02-28

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.

Conditions

Anesthesia; Surgery; Block; Thoracic Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Pectoralic block group

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.

Group Type: EXPERIMENTAL

Bupivacaine Hydrochloride

Intervention Type: 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

Ultrasound

Intervention Type: DEVICE

All blocks will be done under ultrasound

Thoracotomy

Intervention Type: 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

Intervention Type: DRUG

standard pain control with opioids

NSAID

Intervention Type: DRUG

standard pain control with NSAIDs

Control group

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

Group Type: ACTIVE_COMPARATOR

Thoracotomy

Intervention Type: 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

Intervention Type: DRUG

standard pain control with opioids

NSAID

Intervention Type: DRUG

standard pain control with NSAIDs

Interventions

Bupivacaine Hydrochloride

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

Intervention Type: DRUG

Ultrasound

All blocks will be done under ultrasound

Intervention Type: DEVICE

Thoracotomy

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.

Intervention Type: PROCEDURE

Opioids

standard pain control with opioids

Intervention Type: DRUG

NSAID

standard pain control with NSAIDs

Intervention Type: DRUG

Other Intervention Names

Marcaine; Sonosite; Morphine; Perfalgan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Semionov Michael

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SOR 34516 CTIL

Identifier Type: -

Identifier Source: org_study_id