Clavipectoral Block Versus Interscalene Block for Postoperative Analgesia in Midshaft Clavicular Surgery

NCT ID: NCT06917820

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-02-01

Brief Summary

The aim of this study is to compare between (ISBPB) and (CPB) as postoperative analgesic technique following midshaft clavicular fracture open reduction and internal fixation surgeries.

Detailed Description

The aim of this study is to compare between (ISBPB) and (CPB) as postoperative analgesic technique following midshaft clavicular fracture open reduction and internal fixation surgeries. Preoperative full precise medical history will be taken from patients. Routine investigations will be done to all patients including ECG and laboratory investigations as CBC, AST, ALT, INR, PT and PTT. Demographic data as age and weight will be recorded. All patients will be consented for every anesthetic and surgical procedure to be done. For all patients, on arrival to the operating room, ECG, heart rate (HR), non-invasive blood pressure, and pulse oximetry will be monitored. Patients will receive 0.03 mg/kg of IV midazolam as anxiolytic and 3 L/ min nasal oxygen.

Then, in supine position, the diaphragmatic excursion measurement will be performed on the hemidiaphragm at the same side of the study block. Excursion amplitude will be defined as the craniocaudal perpendicular distance from the minimum to the maximum point of diaphragm excursion. Diaphragmatic excursion measurements will be performed before induction of general anesthesia and performing the block technique and at 3 hours after the block or 1 hour after recovery from anesthesia if the surgery lasted more than 2 hours.

After that, induction of GA will be performed by injecting intravenous (IV) 1 mcg/kg fentanyl, 2 mg/kg propofol and 0.5 mg/kg atracurium.

Then, the patients will receive one of the study blocks as following:

Group A: This group will receive ultrasound-guided clavipectoral fascia plane block.

Group B: This group will receive ultrasound-guided interscalene plexus block.

Conditions

Post Operative Pain

Study Design

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

Study Groups

Interscalene brachial plexus block group

Peripheral nerve block Under sterile conditions, the high frequency probe will be positioned at the level of cricoid cartilage to visualize the brachial plexus between the anterior and middle scalene muscles. A total of 20 ml of local anesthetic (10 ml of bupivacaine 0.5% and 10 ml of normal saline) will be injected after negative aspiration, and needle will be adjusted to achieve its spread between the C5 and C6 nerve roots and between C6 and C7 nerve roots.

Group Type: ACTIVE_COMPARATOR

Interscalene brachial plexus block

Intervention Type: PROCEDURE

Ultrasound-guided peripheral nerve block that includes injection of local anesthetics between the C5 and C6 nerve roots and between C6 and C7 nerve roots.

Clavipectoral fascia plane block

Peripheral nerve block Under sterile conditions, a high frequency linear probe will be initially placed over the anterior surface of the clavicle in a sagittal orientation. Essentially, there will be one injection on each side of the fracture after negative aspiration. The first injection will be 4-5 cm from the acromial end of the clavicle and the second one will be 4-5 cm from the sternal end of the clavicle. An in-plane technique will be used to view the needle advancing in a caudad to cephalad direction until it will rest on the clavipectoral fascia. The total amount of local anesthetic (LA) mixture will be 20 ml (10 ml of bupivacaine 0.5% and 10 ml of normal saline), divided into 10 ml medially and 10 ml laterally.

Group Type: ACTIVE_COMPARATOR

Clavipectoral fascia plane block

Intervention Type: PROCEDURE

Ultrasound-guided peripheral nerve block that includes injection of local anesthetics between the periosteum of clavicle and the surrounding clavipectoral fascia.

Interventions

Interscalene brachial plexus block

Ultrasound-guided peripheral nerve block that includes injection of local anesthetics between the C5 and C6 nerve roots and between C6 and C7 nerve roots.

Intervention Type: PROCEDURE

Clavipectoral fascia plane block

Ultrasound-guided peripheral nerve block that includes injection of local anesthetics between the periosteum of clavicle and the surrounding clavipectoral fascia.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients aged from 21 to 60 years.
• American Society of Anesthesiologists (ASA) class I and II status.
• Of both sexes.
• Patients undergoing elective midshaft clavicle fracture open reduction and internal fixation surgery.

Exclusion Criteria

• Patient refusal.
• American Society of Anesthesiologists (ASA) class llI and IV status.
• Patients with bleeding disorders.
• A history of relevant drug allergy to any of the used drugs.
• Alcohol or drug abuse and opioid dependence.
• Pregnant female patients.
• Patients with BMI above 30 kg/m2.
• Patients with infection at site of the fracture or the block procedure.
• Patients with reduced pulmonary functions due to chronic obstructive pulmonary disease (COPD), uncontrolled asthma, pneumothorax or pleural effusion.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moustafa K Reyad, Professor

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Aya A El-Sayed, MSc

Role: CONTACT

aya.anwar@med.asu.edu.eg

01001999075

Ahmed I Nagy, MD

Role: CONTACT

01092575502

Facility Contacts

Aya A El-Sayed, MSc

Role: primary

aya.anwar@med.asu.edu.eg

01001999075

Other Identifiers

MD142/2024

Identifier Type: -

Identifier Source: org_study_id