Post Operative PainNCT06917820
Clavipectoral Block Versus Interscalene Block for Postoperative Analgesia in Midshaft Clavicular Surgery
A study testing Interscalene brachial plexus block and Clavipectoral fascia plane block in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Interscalene brachial plexus block and Clavipectoral fascia plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 14 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Operative Pain
- Being tested
- Interscalene brachial plexus block, Clavipectoral fascia plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
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 blockProcedure or surgery
Ultrasound-guided peripheral nerve block that includes injection of local anesthetics between the periosteum of clavicle and the surrounding clavipectoral fascia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Clavipectoral fascia plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
The time to first rescue analgesia with time frame of 24 hours after the study block will be recorded.
Measured: 24 hours after injection
Rescue analgesia consumed
The total dose of rescue analgesia consumed within 24 hours after the block will be recorded.
Measured: 24 hours after injection
Secondary outcomes (6)
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.
Measured: 3 hours after block or 1 hour after recovery from anesthesia.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 May 2025
- Primary completion14 Mar 2026
- Study completion14 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moustafa K Reyad, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917820
- Sponsor's protocol ID
- MD142/2024
- Status last verified
- May 2026
- First submitted
- 14 Feb 2025
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Clavipectoral Fascia Plane Block Versus Interscalene Brachial Plexus Block for Postoperative Analgesia in Midshaft Clavicular Surgery
- ClinicalTrials.gov ID
- NCT06917820
- Acronym / sponsor ID
- MD142/2024
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 14 Mar 2026 (actual)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene brachial plexus block group | Active comparator | Procedure: Interscalene brachial plexus blockPeripheral 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. |
| Clavipectoral fascia plane block | Active comparator | Procedure: Clavipectoral fascia plane blockPeripheral 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene brachial plexus blockUltrasound-guided peripheral nerve block that includes injection of local anesthetics between the C5 and C6 nerve roots and between C6 and C7 nerve roots. | Procedure or surgery | Interscalene brachial plexus block group |
| Clavipectoral fascia plane blockUltrasound-guided peripheral nerve block that includes injection of local anesthetics between the periosteum of clavicle and the surrounding clavipectoral fascia. | Procedure or surgery | Clavipectoral fascia plane block |
Primary outcome
Time to first rescue analgesia
Time frame: 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
Time frame: 24 hours after injection
The total dose of rescue analgesia consumed within 24 hours after the block will be recorded.
6 secondary outcomes
Incidence of hemi-diaphragmatic paresis
Time frame: 3 hours after block or 1 hour after recovery from anesthesia.
Visual analogue scale (VAS)
Time frame: 24 hours after injection
Heart rate
Time frame: 24 hours after injection
Mean arterial blood pressure
Time frame: 24 hours after injection.
Motor function of the relevant upper limb
Time frame: 3 hours after block or 1 hour after recovery from anesthesia.
Other complications
Time frame: 24 hours after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moustafa K Reyad, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene brachial plexus block and Clavipectoral fascia plane block in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue analgesia (time frame: 24 hours after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.