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

Ultrasound-guided Clavipectoral Fascia Plane Block Versus Interscalene Brachial Plexus Block for Postoperative Analgesia in Midshaft Clavicular Surgery

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: Interscalene brachial plexus block; Procedure: Clavipectoral fascia plane block

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. Base line diaphragmatic excursion will be assessed in all patients in the induction room using a curvilinear low-frequency ultrasound probe (2-5 MHz; SonoSite Inc., Bothell, WA, USA), 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. Then, 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 and 3 L/ min nasal oxygen.

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 35 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS)	The VAS is psychometric measuring instrument designed to document the disease-related symptom severity in individual patients. It will be recorded at 4-hour intervals. A VAS score of 4 or more will be treated with pethidine 50 mg IM as rescue analgesia to be repeated if needed provided that the total 24-hour dosage will not exceed 150 mg.	24 hours after injection
Heart rate	The heart rate of patients will be recorded at baseline just after the block and at the same intervals as the VAS.	24 hours after injection
Mean arterial blood pressure	The mean arterial blood pressure of patients will be recorded at baseline just after the block and at the same intervals as the VAS.	24 hours after injection.
Motor function of the relevant upper limb	Motor function of the relevant upper limb will be evaluated 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 in the distribution of the axillary nerve (shoulder abduction), musculocutaneous nerve (elbow flexion), radial nerve (wrist extension), median nerve (wrist flexion), and ulnar nerve (thumb/finger adduction) using a 3-point scale (0 = normal strength, 1 = paresis, or 2 = paralysis), with maximal total motor block score of 10.	3 hours after block or 1 hour after recovery from anesthesia.
Other complications	Complications like postoperative nausea and vomiting, Horner's syndrome and pneumothorax will be recorded.	24 hours after injection
Incidence of hemi-diaphragmatic paresis	The incidence of hemi-diaphragmatic paresis at 3 hours after block or 1 hour after recovery from anesthesia if the surgery lasted more than 2 hours. Hemi-diaphragmatic paresis will be defined as greater than 50% reduction in diaphragmatic excursion compared with the pre block value during deep breathing.	3 hours after block or 1 hour after recovery from anesthesia.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Moustafa K Reyad, Professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): March 14, 2026
• Study Completion (Actual): March 14, 2026

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: MD142/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No