Pain, AcuteNCT05176938
Effect of Ultrasound Guided Thoracic Interfascial Plane Block Versus Erector Spinae Plane Block After Mastectomy
A study testing Ultrasound guided Thoracic Interfascial plane Block (TIFB) and Ultrasound guided Erector Spinae plane Block (ESPB) in people with Pain, Acute and Erector Spinae Plane Block, run by Tanta University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain, Acute, Erector Spinae Plane Block, Mastectomy, Modified Radical
- What is being tested?
- Ultrasound guided Thoracic Interfascial plane Block (TIFB) and Ultrasound guided Erector Spinae plane Block (ESPB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2022to 24 Nov 2022
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients admitted for modified radical mastectomy surgery.
- American Society of Anesthesiologists (ASA) physical activity I, II
- Aged (18 - 65) years
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Pain, Acute, Erector Spinae Plane Block, Mastectomy, Modified Radical, Thoracic Interfascial Plane Block, Pain, Chronic
- Being tested
- Ultrasound guided Thoracic Interfascial plane Block (TIFB), Ultrasound guided Erector Spinae plane Block (ESPB)
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Thoracic Interfascial plane Block (TIFB)Procedure or surgery
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.
Ultrasound guided Erector Spinae plane Block (ESPB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided Thoracic Interfascial plane Block (TIFB) | Experimental | 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. Receives: Procedure: Ultrasound guided Thoracic Interfascial plane Block (TIFB) |
| Ultrasound guided Erector Spinae plane Block (ESPB) | Experimental | Patients will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the fourth thoracic segment (T4). Receives: Procedure: Ultrasound guided Erector Spinae plane Block (ESPB) |
| General anesthesia | No intervention | Patients will receive general anesthesia only without blocks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours postoperative
Secondary outcomes (3)
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.
Measured: 24 hours Postoperative
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)
Measured: 24 hours Postoperative
Complications occurrence (hypotension, pneumothorax, bradycardia)
Adverse events as Bradycardia, hypotension, drowsiness, and dizziness) will be recorded 24 hours Postoperatively.
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start10 Jan 2022 (estimated)
- Primary completion24 Nov 2022 (estimated)
- Study completion24 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areeg Kotb Ghalwash, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176938
- Sponsor's protocol ID
- 33645/1/20
- Status last verified
- Dec 2021
- First submitted
- 22 Nov 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The supporting data will be available upon a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05176938
- Acronym / sponsor ID
- 33645/1/20
- Conditions
- Pain, Acute, Erector Spinae Plane Block, Mastectomy, Modified Radical, Thoracic Interfascial Plane Block, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (estimated)
- Primary completion
- 24 Nov 2022 (estimated)
- Study completion
- 24 Nov 2022 (estimated)
- First posted
- 4 Jan 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided Thoracic Interfascial plane Block (TIFB) | Experimental | Procedure: Ultrasound guided Thoracic Interfascial plane Block (TIFB)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. |
| Ultrasound guided Erector Spinae plane Block (ESPB) | Experimental | Procedure: Ultrasound guided Erector Spinae plane Block (ESPB)Patients will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the fourth thoracic segment (T4). |
| General anesthesia | No intervention | –Patients will receive general anesthesia only without blocks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients admitted for modified radical mastectomy surgery.
- American Society of Anesthesiologists (ASA) physical activity I, II
- Aged (18 - 65) years
Key exclusion criteria (6 listed)
- Patient refusal.
- Patient with neurological deficit.
- Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant, and antiplatelet drugs).
- Uncooperative patient.
- Infection at the block injection site.
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 |
|---|---|---|
| Ultrasound guided Thoracic Interfascial plane Block (TIFB)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. | Procedure or surgery | Ultrasound guided Thoracic Interfascial plane Block (TIFB) |
| Ultrasound guided Erector Spinae plane Block (ESPB)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. | Procedure or surgery | Ultrasound guided Erector Spinae plane Block (ESPB) |
Primary outcome
Total analgesics consumption in the first 24h after surgery.
Time frame: 24 hours postoperative
Total analgesic consumption (fentanyl intraoperative) and (morphine 0.05 mg / kg per dose at the first 24 h after surgery).
3 secondary outcomes
Time to first analgesic request after surgery
Time frame: 24 hours Postoperative
Visual Analogue score (VAS)
Time frame: 24 hours Postoperative
Complications occurrence (hypotension, pneumothorax, bradycardia)
Time frame: 24 hours Postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: Yes. The supporting data will be available upon a reasonable request from the corresponding author.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided Thoracic Interfascial plane Block (TIFB) and Ultrasound guided Erector Spinae plane Block (ESPB) in people with Pain, Acute and Erector Spinae Plane Block, run by Tanta University.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Areeg K. Ghalwash, MD (1020103170 ext. +20, Areg.kotb@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total analgesics consumption in the first 24h after surgery. (time frame: 24 hours postoperative). 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 4 Jan 2022.