- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936852
Ultrasound Guided Serratus Posterior Superior Intercostal Plane Versus PECS II Block In Breast Surgeries
Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Pectoral Nerve (PECS II) Block For Pain Control In Breast Surgeries: A Randomized Comparative Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients will be seen in the anesthesia clinic, optimization of general condition and all required investigations will be done before surgery. Patients will be premedicated with 1.5 mg midazolam and 4 mg granisetron. Standard basic monitoring will be applied to all patients then after adequate preoxygenation, induction of general anesthesia will be done through wide bore cannula using 1 mic/kg fentanyl, 1-2 mg/kg titration of propofol, 0.5mg/kg atracurium. Patients were mechanically ventilated using volume-controlled ventilation (VCV) with adjustment of end tidal carbon dioxide (ETCO2) to be 32-35 mmHg, 50% inspired oxygen in air and sevoflurane concentration to be 1MAC. The patients will receive either block before skin incision that will be done 20 minutes after the block. 0.5 mic/kg fentanyl will be injected when heart rate or blood pressure increases more than 20% of baseline. By the end of the surgery, 1gm paracetamol will be administered with fully reversal of muscle relaxants at the end of the surgery.
SPSIP group After induction of anesthesia, patients will be placed in lateral decubitus position, the affected arm will be adducted and medially rotated. Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The structures from superficial to deep are skin, subcutaneous, trapezius, rhomboid, serratus posterior superior and intercostal muscles. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.
PECS II group With the patient in supine position, the ipsilateral upper arm will be abducted and externally rotated. Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.
After extubation, the patients will be transferred to PACU (Post-Anesthesia Care Unit) for monitoring. Numerical rating scale (NRS) will be used for pain assessment while 0 is no pain and 10 is severe agonizing pain. Patients will be given a rescue analgesia of 0.05 mg / kg morphine if NRS ≥ 4 and repeated if needed. Intravenous 1 gm paracetamol every 8 h and 30 mg ketorolac (if not contraindicated) every 12 h will be given regularly.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Select
-
Tanta, Select, Egypt, 1234
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 21 to 70 years.
- American Society of Anesthesiologists (ASA) Physical Status Classification System I-II.
Exclusion Criteria:
- Any patient refuses to participate.
- Bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases.
- Chronic opioid use.
- Patients with pulmonary diseases.
- History of allergy to local anesthetics.
- Infection at the needle entry point will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SPSIP Group
Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs.
The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.
|
Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs.
The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.
|
|
Active Comparator: PECS II group
Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep.
The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.
|
. Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep.
The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: first postoperative 24 hour
|
Total morphine consumption in first postoperative twenty four hour
|
first postoperative 24 hour
|
|
Bedside forced vital capacity at 2 hours after surgery
Time Frame: Two hours after surgery
|
Three measurements were taken and the highest one was recorded
|
Two hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first rescue opioid dose
Time Frame: 24 hours after surgery
|
Morphine given for pain scores more than or equal to 4
|
24 hours after surgery
|
|
Incidence of chronic pain at 3 and 6 months after surgery
Time Frame: 6 months after surgery
|
Any pain with score more than 3 is considered positive for chronic pain
|
6 months after surgery
|
|
Block related complications and side effects
Time Frame: 24 hours after surgery
|
Vomiting, bradycardia, hypotension, and pneumothorax will be recorded
|
24 hours after surgery
|
|
Bedside forced vital capacity at 6 and 24 hours after surgery
Time Frame: 24 hours after surgery
|
Three measurements were taken and the highest one was recorded
|
24 hours after surgery
|
|
NRS pain scores for breast and axilla when reaching recovery room arrival, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour at rest and during arm movement
Time Frame: when reaching recovery room (average 10 minutes after surgery), after two, six, twelve, eighteen, twenty four hour
|
NRS when reaching recovery room, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour
|
when reaching recovery room (average 10 minutes after surgery), after two, six, twelve, eighteen, twenty four hour
|
|
Additional intraoperative fentanyl consumption
Time Frame: during surgery
|
Additional intraoperative fentanyl consumption which not used during induction
|
during surgery
|
|
Heart rate and mean arterial blood pressure
Time Frame: baseline and during surgery
|
• Heart rate and mean arterial blood pressure
|
baseline and during surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36264PR1097/2/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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