Effect of Ultrasound Guided Thoracic Interfascial Plane Block Versus Erector Spinae Plane Block After Mastectomy
Primary Purpose
Pain, Acute, Erector Spinae Plane Block, Mastectomy, Modified Radical
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound guided Thoracic Interfascial plane Block (TIFB)
Ultrasound guided Erector Spinae plane Block (ESPB)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- Female patients admitted for modified radical mastectomy surgery.
- American Society of Anesthesiologists (ASA) physical activity I, II
- Aged (18 - 65) years
Exclusion Criteria:
- Patient refusal.
- Patient with neurological deficit.
- Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant, and antiplatelet drugs).
- Uncooperative patient.
- Infection at the block injection site.
- Patients with a history of allergy to drugs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Ultrasound guided Thoracic Interfascial plane Block (TIFB)
Ultrasound guided Erector Spinae plane Block (ESPB)
General anesthesia
Arm Description
Patients will receive (20ml) (plain bupivacaine 0.25% injected in the serratus intercostal space at 6 ribs midaxillary line and (20ml) in pecto-intercostal space at 2 ribs parasternal.
Patients will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the fourth thoracic segment (T4).
Patients will receive general anesthesia only without blocks.
Outcomes
Primary Outcome Measures
Total analgesics consumption in the first 24h after surgery.
Total analgesic consumption (fentanyl intraoperative) and (morphine 0.05 mg / kg per dose at the first 24 h after surgery).
Secondary Outcome Measures
Time to first analgesic request after surgery
Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg) If VAS ≥ 4 all patient will receive paracetamol 1gm /6h.
Visual Analogue score (VAS)
Pain will be assessed after surgery over 24 hour using VAS score where (0 = no pain and 10 = severe pain) at (T 30 min, 2, 4, 6, 12, 18, 24 h), if less than 4 non-steroidal anti-inflammatory will be given (ketorolac 30mg) and if more than 4 intra venous morphine (0.05mg / kg)
Complications occurrence (hypotension, pneumothorax, bradycardia)
Adverse events as Bradycardia, hypotension, drowsiness, and dizziness) will be recorded 24 hours Postoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05176938
Brief Title
Effect of Ultrasound Guided Thoracic Interfascial Plane Block Versus Erector Spinae Plane Block After Mastectomy
Official Title
Effect of Preoperative Ultrasound Guided Thoracic Interfascial Plane Block Versus Preoperative Thoracic Erector Spinae Plane Block on Acute and Chronic Pain After Modified Radical Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 10, 2022 (Anticipated)
Primary Completion Date
November 24, 2022 (Anticipated)
Study Completion Date
November 24, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will be conducted to compare the efficacy of ultrasound guided thoracic interfascial plane block versus ultrasound guided erector spinae plane block on acute and chronic pain after modified radical mastectomy surgery.
Detailed Description
Various thoracic nerve blocks performed for pain control after breast cancer surgery provide superior analgesic effect and reduce postoperative nausea and vomiting as a result of the decreased use of opioid analgesics.
Ultrasound-guided erector spinae block (ESB) is a regional anesthesia technique; recently described by Forero et al, in management of thoracic neuropathic pain. It became popular because it is much safer and easily administered than other alternative regional techniques as paravertebral and thoracic epidural block.
ESB leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery, and T 7 level for abdominal surgeries. Spread of local anesthetic following ESB in the cephalic and caudal directions can lead to analgesia from C7 to L2-3.
There have been several reports that thoracic interfascial plane block is useful for multimodal analgesia in patients undergoing mastectomy, Thoracic interfascial plane block including pecto-intercostal fascial plane block (PIFB) and serratus intercostal fascial plane block (SIFB).
Thoracic interfascial plane block is the peripheral nerve block that targets the intercostal nerves branches distributed in the chest and axilla, Although PIFB and SIFB are thought to be relatively easy to perform there have been no reports of the simultaneous performance of the two blocks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Erector Spinae Plane Block, Mastectomy, Modified Radical, Thoracic Interfascial Plane Block, Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound guided Thoracic Interfascial plane Block (TIFB)
Arm Type
Experimental
Arm Description
Patients will receive (20ml) (plain bupivacaine 0.25% injected in the serratus intercostal space at 6 ribs midaxillary line and (20ml) in pecto-intercostal space at 2 ribs parasternal.
Arm Title
Ultrasound guided Erector Spinae plane Block (ESPB)
Arm Type
Experimental
Arm Description
Patients will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the fourth thoracic segment (T4).
Arm Title
General anesthesia
Arm Type
No Intervention
Arm Description
Patients will receive general anesthesia only without blocks.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided Thoracic Interfascial plane Block (TIFB)
Intervention Description
Patients of the group will be placed supine and elevate arm to the head, Serratus intercostal plane block will be with the probe in the midaxillary line, The subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction after giving 3 ml lidocaine locally. In-plane technique was used until the tip of the needle placed between the serratus anterior muscle and the external intercostals muscle a volume of 20 ml plain bupivacaine will be injected.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided Erector Spinae plane Block (ESPB)
Intervention Description
The patient will be placed in setting position and a superficial (5-12 MHz) ultrasound transducer will be placed in a longitudinal orientation, 3 cm lateral to the T4 spinous process. An 8-cm 22-gauge spinal needle will be inserted in cephalic direction after giving 3 ml lidocaine locally until the needle tip hit the transverse process of T4 under ultrasound image visualization, then the needle will be withdrawn slowly to be within the interfacial plane below the erector spinae muscle, then the anesthetic mixture will be injected here. Successful injection will be evidenced by visible linear free spread (cranially and caudally) of injectate below the muscle.
Primary Outcome Measure Information:
Title
Total analgesics consumption in the first 24h after surgery.
Description
Total analgesic consumption (fentanyl intraoperative) and (morphine 0.05 mg / kg per dose at the first 24 h after surgery).
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Time to first analgesic request after surgery
Description
Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg) If VAS ≥ 4 all patient will receive paracetamol 1gm /6h.
Time Frame
24 hours Postoperative
Title
Visual Analogue score (VAS)
Description
Pain will be assessed after surgery over 24 hour using VAS score where (0 = no pain and 10 = severe pain) at (T 30 min, 2, 4, 6, 12, 18, 24 h), if less than 4 non-steroidal anti-inflammatory will be given (ketorolac 30mg) and if more than 4 intra venous morphine (0.05mg / kg)
Time Frame
24 hours Postoperative
Title
Complications occurrence (hypotension, pneumothorax, bradycardia)
Description
Adverse events as Bradycardia, hypotension, drowsiness, and dizziness) will be recorded 24 hours Postoperatively.
Time Frame
24 hours Postoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients admitted for modified radical mastectomy surgery.
American Society of Anesthesiologists (ASA) physical activity I, II
Aged (18 - 65) years
Exclusion Criteria:
Patient refusal.
Patient with neurological deficit.
Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant, and antiplatelet drugs).
Uncooperative patient.
Infection at the block injection site.
Patients with a history of allergy to drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Areeg K. Ghalwash, MD
Phone
1020103170
Ext
+20
Email
Areg.kotb@med.tanta.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The supporting data will be available upon a reasonable request from the corresponding author.
IPD Sharing Time Frame
one year after the end of the study
Learn more about this trial
Effect of Ultrasound Guided Thoracic Interfascial Plane Block Versus Erector Spinae Plane Block After Mastectomy
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