Pectoralis and Serratus Nerves Block in Thoracic Surgery

• Sponsor: Soroka University Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03023982
• Collaborator: (none)
• Enrollment: 168
• Arms: 2
• Duration (Months): 24

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Surgery; Block; Thoracic Injury	Drug: Bupivacaine Hydrochloride; Device: Ultrasound; Procedure: Thoracotomy; Drug: Opioids; Drug: NSAID	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Ultrasound Guided PECs II (Pectoralis and Serratus Nerves) Block in Patients Undergoing a Thoracic Surgery
• Study Start Date: Feb 1, 2017
• Anticipated Primary Completion Date: Feb 1, 2019
• Anticipated Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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; Other Names: Marcaine ; Device: Ultrasound; All blocks will be done under ultrasound; Other Names: Sonosite ; Procedure: 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.; Drug: Opioids; standard pain control with opioids; Other Names: Morphine ; Drug: NSAID; standard pain control with NSAIDs; Other Names: Perfalgan
Active Comparator: Control group Patients in this group will receive standard pain control with opioids and NSAIDs	Procedure: 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.; Drug: Opioids; standard pain control with opioids; Other Names: Morphine ; Drug: NSAID; standard pain control with NSAIDs; Other Names: Perfalgan

Outcome Measures

Primary Outcome Measures

1. Comparison Visual Analog Score between groups [First 24 hours from the surgery]

   First VAS after admission in PACU

Secondary Outcome Measures

1. Total NSAIDs dosage (mg) in the PACU and department [First 24 hours from the surgery]

   While the patient is in PACU

2. Length of hospital stay [up to 21 days]

   Measuring time of at discharge from hospital

3. Total morphine dosage (mg) in the PACU and department [First 24 hours from the surgery]

   While the patient is in PACU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Soroka University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Semionov Michael, Primary Investigator, Soroka University Medical Center
• ClinicalTrials.gov Identifier: NCT03023982
• Other Study ID Numbers: SOR 34516 CTIL
• First Posted: Jan 18, 2017
• Last Update Posted: Jan 18, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Thoracic Injuries; Morphine; Bupivacaine

Study Results

No Results Posted as of Jan 18, 2017