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

Not Applicable

Recruiting

• Conditions: Post Operative Pain

• Registration Number: NCT06917820
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to first rescue analgesia	24 hours after injection	The time to first rescue analgesia with time frame of 24 hours after the study block will be recorded.
Rescue analgesia consumed	24 hours after injection	The total dose of rescue analgesia consumed within 24 hours after the block will be recorded.

Secondary Outcome Measures

Name	Time	Method
Incidence of hemi-diaphragmatic paralysis	3 hours after block or 1 hour after recovery from anesthesia.	The incidence of hemi-diaphragmatic paralysis at 3 hours after block or 1 hour after recovery from anesthesia if the surgery lasted more than 2 hours. Hemi-diaphragmatic paralysis will be defined as greater than 50% reduction in diaphragmatic excursion compared with the pre block value during deep breathing.
Other complications	24 hours after injection	Complications like postoperative nausea and vomiting, Horner's syndrome and pneumothorax will be recorded.
Visual analogue scale (VAS)	24 hours after injection	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.
Motor function of the relevant upper limb	3 hours after block or 1 hour after recovery from anesthesia.	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.
Heart rate	24 hours after injection	The heart rate of patients will be recorded at baseline just after the block and at the same intervals as the VAS.
Mean arterial blood pressure	24 hours after injection.	The mean arterial blood pressure of patients will be recorded at baseline just after the block and at the same intervals as the VAS.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt