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

NCT06917820 | Completed

• 1 other identifier: MD142/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (2)

• Time to first rescue analgesia

  The time to first rescue analgesia with time frame of 24 hours after the study block will be recorded.

  24 hours after injection

• Rescue analgesia consumed

  The total dose of rescue analgesia consumed within 24 hours after the block will be recorded.

  24 hours after injection

Secondary Outcomes (6)

• Incidence of hemi-diaphragmatic paralysis

  3 hours after block or 1 hour after recovery from anesthesia.

• Visual analogue scale (VAS)

  24 hours after injection

• Heart rate

  24 hours after injection

• Mean arterial blood pressure

  24 hours after injection.

• Motor function of the relevant upper limb

  3 hours after block or 1 hour after recovery from anesthesia.

Study Arms (2)

Interscalene brachial plexus block group

ACTIVE COMPARATOR

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.

Procedure: Interscalene brachial plexus block

Clavipectoral fascia plane block

ACTIVE COMPARATOR

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.

Procedure: Clavipectoral fascia plane block

Interventions

Interscalene brachial plexus block 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.

Interscalene brachial plexus block group

Clavipectoral fascia plane block PROCEDURE

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

Clavipectoral fascia plane block

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Moustafa K Reyad, Professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: April 9, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-01

Locations

EG (1)