Clinical trial NCT06917820: Clavipectoral Block Versus Interscalene Block for Postoperative Analgesia in Midshaft Clavicular Surgery
Official title: Ultrasound-guided Clavipectoral Fascia Plane Block Versus Interscalene Brachial Plexus Block for Postoperative Analgesia in Midshaft Clavicular Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Time to first rescue analgesia
timeFrame: 24 hours after injection
measure: Rescue analgesia consumed
timeFrame: 24 hours after injection
Secondary outcomes:
measure: Incidence of hemi-diaphragmatic paralysis
timeFrame: 3 hours after block or 1 hour after recovery from anesthesia.
measure: Visual analogue scale (VAS)
timeFrame: 24 hours after injection
measure: Heart rate
timeFrame: 24 hours after injection
measure: Mean arterial blood pressure
timeFrame: 24 hours after injection.
measure: Motor function of the relevant upper limb
timeFrame: 3 hours after block or 1 hour after recovery from anesthesia.
measure: Other complications
timeFrame: 24 hours after injection
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Moustafa K Reyad, Professor
role: STUDY_DIRECTOR
References: