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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03023982
Other study ID # SOR 34516 CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received January 3, 2017
Last updated January 17, 2017
Start date February 2017
Est. completion date February 2019

Study information

Verified date January 2017
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 168
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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
Device:
Ultrasound
All blocks will be done under ultrasound
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
NSAID
standard pain control with NSAIDs

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Soroka University Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison Visual Analog Score between groups First VAS after admission in PACU First 24 hours from the surgery
Secondary Total NSAIDs dosage (mg) in the PACU and department While the patient is in PACU First 24 hours from the surgery
Secondary Length of hospital stay Measuring time of at discharge from hospital up to 21 days
Secondary Total morphine dosage (mg) in the PACU and department While the patient is in PACU First 24 hours from the surgery
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