Post Operative PainNCT05452369
Postoperative Anelgesic Effect of Rhomboid Intercostal Nerve Block Versus Erector Spinae Plane Block
A study testing Rhomboid intercostal plane block in people with Post Operative Pain, run by ghada fouad at 2 sites in Egypt.
Trial summary
Despite of analgesic effect of intravenous analgesic medications at intraoperative and postoperative time , The regional anesthetic techniquehas more benefits suchbetter control of Acute pain and hence less chronic pain and decreases the need for opioids and analgesics to preserve immune function which responsible for… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Rhomboid intercostal plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2021to 1 Dec 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Female patients aged between 25-65 years.
- ASA physical status I or II.
- Scheduled for elective unilateral modified radical mastectomy
Who cannot join
- - Patient refusal.
- Infection at the site of injection.
- Hypersensitivity to the local anesthetic
- Bleeding disorders.
- Patients with cardiac, hepatic, and renal failure.
- BMI ≥40 kg/m2
- Patient with serum cr > 1.5
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Mansoura University
Al Mansurah
About this study
Official title: Ultrasound Guided Rhomboid Intercostal Nerve Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy:A Comparative Study
Despite of analgesic effect of intravenous analgesic medications at intraoperative and postoperative time , The regional anesthetic techniquehas more benefits suchbetter control of Acute pain and hence less chronic pain and decreases the need for opioids and analgesics to preserve immune function which responsible for higher rates of infection and local recurrence, even metastasis .
New regional anesthetic technique for modified radical mastectomy discovered recently called rhomboid intercostal nerve block that will compared against erector spinae plane block .
Read the detailed description
The aim of this study is to compare the post-operative analgesic effect of ultrasound-guided rhomboid intercostal nerve block versus erector spinae plane block as regard total analgesic requirements, duration of effective analgesia,postoperative visual analog score (VAS), peri-operative hemodynamics,peri-operative complications and incidence of chronic postmastectomy pain.The technique of rhomboid intercostal nerve block:
After induction of anesthesia, the patient will be positioned in lateral decubitus with the operated side above. After sterilization of the patient's back, A linear ultrasound transducer (6-12 MHz) will place medial to the lower border of the scapula with the orientation marker directed cranially. The ultrasound landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified. The tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection is administered at the T4-5. 80mm 21-gage needle will be inserted in the plane view of the ultrasound probe at the level of T4-5. After negative aspiration of blood or air, the rhomboid intercostal plane was hydro located with 2 mL of normal saline to confirm the correct needle tip position. A single injection of 30 ml of bupivacaine 0.25% will be applied into the interfacial plane between the rhomboid major and intercostal muscles. The spread of local anesthetic solution under the rhomboid muscle will be visualized by ultrasonography.
The technique of Erector spinae plane block (ESP):
After induction of anesthesia, the patient will be positioned in lateral decubitus with the operated side above. After sterilization of the patient's back, A linear ultrasound probe willplace 3-cm lateral to the midline at the level of T5 interspinous space and transverse process and three muscles willidentify: trapezius, rhomboid major, and erector spinae. A 10-cm needle was inserted craniocaudally in-plane, to reach the transverse process. After hydrodissection of the plane with 3 mL of normal saline, 30 ml of 0.25% bupivacainewilldeposit and thus erector spinae muscle will lift off the transverse process.
Block assessment will be performed using ice cube withtemperature of 4°C at midclavicular linein post anesthesia care unit after Full recovery which be confirmed when Aldrete's score ≥9 .
Block success means at least3 dermatomal segments should be having decreased sensation to cold.
Failed block will be excluded from the study and patient will replaced by another patient.
- Conditions
- Post Operative Pain
- Being tested
- Rhomboid intercostal plane block
- Keywords
- Modified Radical Mastectomy, Rhomboid Intercostal Nerve Block, Erector Spinae 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.
Rhomboid intercostal plane blockDrug
Also called fascial plane block
- 30 mL bupivacaine 0.25% will injected ultrasound-guided in rhomboid intercostal fascial plane .
| Study group | Role | What they receive |
|---|---|---|
| rhomboid intercostal plane block | Experimental | as in intervention description Receives: Drug: Rhomboid intercostal plane block |
| Erector spinae plane block | Experimental | As in intervention description Receives: Drug: Rhomboid intercostal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total analgesic requirements during the first 24 hours postoperative.
All patients will receive standard postoperative analgesia (1gm paracetamol every 8 hours IV).
Measured: 0,2,4,6,8,10,12,16,20,24 hours postoperatively
Secondary outcomes (1)
The duration of effective analgesia
time interval between the end of surgery and first analgesic request .
Measured: 0,2,4,6,8,10,12,16,20,24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Oct 2021
- Primary completion1 Aug 2022
- Study completion1 Dec 2022 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- \- Two arms: rhomboid intercostal plane block is the first group Erector spinae plane block is the second group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ghada fouad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ghada fouad, Mansoura University
- Investigators
- mohamed y makharita, MD, Study director, Professor OFanesthesia Mansoura universityghada f amer, MD, Study chair, Assistant professor of anesthesia Mansoura universityahmed E Kamal, resident, Principal investigator, resident of anesthesia mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452369
- Sponsor's protocol ID
- MFM-IRB,MS.21.09.1654
- Status last verified
- Oct 2022
- First submitted
- 6 Jul 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Rhomboid Intercostal Nerve Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy:A Comparative Study
- ClinicalTrials.gov ID
- NCT05452369
- Acronym / sponsor ID
- MFM-IRB,MS.21.09.1654
- Conditions
- Post Operative Pain
- Keywords
- Modified Radical Mastectomy, Rhomboid Intercostal Nerve Block, Erector Spinae Plane Block .
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- ghada fouadUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 11 Jul 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.
Despite of analgesic effect of intravenous analgesic medications at intraoperative and postoperative time , The regional anesthetic techniquehas more benefits suchbetter control of Acute pain and hence less chronic pain and decreases the need for opioids and analgesics to preserve immune function which responsible for higher rates of infection and local recurrence, even metastasis .
New regional anesthetic technique for modified radical mastectomy discovered recently called rhomboid intercostal nerve block that will compared against erector spinae plane block .
Detailed description
The aim of this study is to compare the post-operative analgesic effect of ultrasound-guided rhomboid intercostal nerve block versus erector spinae plane block as regard total analgesic requirements, duration of effective analgesia,postoperative visual analog score (VAS), peri-operative hemodynamics,peri-operative complications and incidence of chronic postmastectomy pain.The technique of rhomboid intercostal nerve block:
After induction of anesthesia, the patient will be positioned in lateral decubitus with the operated side above. After sterilization of the patient's back, A linear ultrasound transducer (6-12 MHz) will place medial to the lower border of the scapula with the orientation marker directed cranially. The ultrasound landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified. The tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection is administered at the T4-5. 80mm 21-gage needle will be inserted in the plane view of the ultrasound probe at the level of T4-5. After negative aspiration of blood or air, the rhomboid intercostal plane was hydro located with 2 mL of normal saline to confirm the correct needle tip position. A single injection of 30 ml of bupivacaine 0.25% will be applied into the interfacial plane between the rhomboid major and intercostal muscles. The spread of local anesthetic solution under the rhomboid muscle will be visualized by ultrasonography.
The technique of Erector spinae plane block (ESP):
After induction of anesthesia, the patient will be positioned in lateral decubitus with the operated side above. After sterilization of the patient's back, A linear ultrasound probe willplace 3-cm lateral to the midline at the level of T5 interspinous space and transverse process and three muscles willidentify: trapezius, rhomboid major, and erector spinae. A 10-cm needle was inserted craniocaudally in-plane, to reach the transverse process. After hydrodissection of the plane with 3 mL of normal saline, 30 ml of 0.25% bupivacainewilldeposit and thus erector spinae muscle will lift off the transverse process.
Block assessment will be performed using ice cube withtemperature of 4°C at midclavicular linein post anesthesia care unit after Full recovery which be confirmed when Aldrete's score ≥9 .
Block success means at least3 dermatomal segments should be having decreased sensation to cold.
Failed block will be excluded from the study and patient will replaced by another patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- - Two arms: rhomboid intercostal plane block is the first group Erector spinae plane block is the second group
| Arm | Type | Receives |
|---|---|---|
| rhomboid intercostal plane block | Experimental | Drug: Rhomboid intercostal plane blockas in intervention description |
| Erector spinae plane block | Experimental | Drug: Rhomboid intercostal plane blockAs in intervention description |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Female patients aged between 25-65 years.
- ASA physical status I or II.
- Scheduled for elective unilateral modified radical mastectomy
Key exclusion criteria (7 listed)
- - Patient refusal.
- Infection at the site of injection.
- Hypersensitivity to the local anesthetic
- Bleeding disorders.
- Patients with cardiac, hepatic, and renal failure.
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 |
|---|---|---|
| Rhomboid intercostal plane blockAlso: fascial plane block- 30 mL bupivacaine 0.25% will injected ultrasound-guided in rhomboid intercostal fascial plane . | Drug | Erector spinae plane block, rhomboid intercostal plane block |
Primary outcome
The total analgesic requirements during the first 24 hours postoperative.
Time frame: 0,2,4,6,8,10,12,16,20,24 hours postoperatively
All patients will receive standard postoperative analgesia (1gm paracetamol every 8 hours IV).
1 secondary outcome
The duration of effective analgesia
Time frame: 0,2,4,6,8,10,12,16,20,24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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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.
mohamed y makharita, MD study director
Professor OFanesthesia Mansoura university
ghada f amer, MD study chair
Assistant professor of anesthesia Mansoura university
ahmed E Kamal, resident principal investigator
resident of anesthesia mansoura university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhomboid intercostal plane block in people with Post Operative Pain, run by ghada fouad at 2 sites 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 3 inclusion and 7 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
The total analgesic requirements during the first 24 hours postoperative. (time frame: 0,2,4,6,8,10,12,16,20,24 hours postoperatively). 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 12 Oct 2022.