Postoperative PainNCT05661279
Rhomboid Intercostal Block Versus Serratus Anterior Plane Block
A study testing general anesthesia, general anesthesia plus Rhomboid intercostal block and Serratus anterior plane block in people with Postoperative Pain, run by Zagazig University at 1 site in Egypt.
Trial summary
evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- general anesthesia, general anesthesia plus Rhomboid intercostal block and Serratus anterior 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
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2022to 30 Oct 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients aged between 21 to 60 years
- Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia
- Informed consents
- ASA I \& II
- Body mass index 25-30 kg/m2.
Who cannot join
- patients on anti-platelet, anticoagulant or B blocker drugs
- Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function
- history of allergy to local anesthesia or opioid analgesia,
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Heba M Fathi
Zagazig, 44519
Heba M Fathi, M.D, heba_elgendi@yahoo.com
About this study
Official title: Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Analgesia After Thoracodorsal Artery Perforator Flap Following Partial Mastectomy
evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy
Read the detailed description
- To assess and compare quality of post- operative analgesia in each group.
- Time of performance of block in both groups.
- To assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension.
- Conditions
- Postoperative Pain
- Being tested
- general anesthesia, general anesthesia plus Rhomboid intercostal block, Serratus anterior plane block
- Keywords
- rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaProcedure or surgery
general anesthesia
general anesthesia plus Rhomboid intercostal blockProcedure or surgery
the patients will be positioned in lateral decubitus with moving the scapula laterally by abducting the ipsilateral arm across the chest. under complete aseptic situations A high-frequency (6-12 MHz) linear US probe will be put medial to the medial border of the scapula in an oblique sagittal plane with the orientation marker directed cranially.at the T6-7 level, the tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection of 25mL of bupivacaine (0.25%) will be administered via 18-gauge Tuohy advanced in plane from a superomedial to an inferolateral direction, followed by general anesthesia
Serratus anterior plane blockProcedure or surgery
The patient will be positioned supine with his arm abducts at 90°. the US high frequency (6-12 MHz) linear probe of sonosite M turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be put in sagittal plane at the midaxillary line. identification of the fascial plane between the serratus anterior muscle and external intercostal muscles will be performed between the fourth and fifth ribs in the midaxillary area . At this point the18-gauge Tuohy needle will be advanced in plane with injection of 25mL of 0.25 %, bupivacaine. followed by general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group C: | Active comparator | control group who will be given general anesthesia only Receives: Procedure: general anesthesia |
| Group R: | Active comparator | Rhomboid intercostal block then general anesthesia Receives: Procedure: general anesthesia; Procedure: general anesthesia plus Rhomboid intercostal block |
| group S | Active comparator | Serratus anterior plane block then general anesthesia Receives: Procedure: general anesthesia; Procedure: Serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
tramadol consumption
The amount of tramadol consumption
Measured: at 24 hours postoperative
Secondary outcomes (4)
Time of performance of block
Time needed to performance the block
Measured: time from positioning of ultrasound porbe till the end of block procedure.
Time to first dose of rescue analgesia
the first time that the patients need analgesia when VAS ≥ 3
Measured: during the first 24 hours postoperatively
Anticipated side effect
nausea, vomiting, local anesthesia toxicity, needle injury
Measured: at 24 hous post operative
Post operative patient's satisfaction
Post operative patient's satisfaction using 3 point scale (1= satisfied ,2=neutral, 3=not satisfied)
Measured: at 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start30 Dec 2022
- Primary completion2 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heba M Fathi, Zagazig University
- Investigators
- Heba M Fathi, Principal investigator, faculty of human medicine ,zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661279
- Sponsor's protocol ID
- zu-IRB # 10060
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Analgesia After Thoracodorsal Artery Perforator Flap Following Partial Mastectomy
- ClinicalTrials.gov ID
- NCT05661279
- Acronym / sponsor ID
- zu-IRB # 10060
- Conditions
- Postoperative Pain
- Keywords
- rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 2 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 22 Dec 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.
evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy
Detailed description
- To assess and compare quality of post- operative analgesia in each group.
- Time of performance of block in both groups.
- To assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C: | Active comparator | Procedure: general anesthesiacontrol group who will be given general anesthesia only |
| Group R: | Active comparator | Procedure: general anesthesia, Procedure: general anesthesia plus Rhomboid intercostal blockRhomboid intercostal block then general anesthesia |
| group S | Active comparator | Procedure: general anesthesia, Procedure: Serratus anterior plane blockSerratus anterior plane block then general anesthesia |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients aged between 21 to 60 years
- Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia
- Informed consents
- ASA I \& II
- Body mass index 25-30 kg/m2.
Key exclusion criteria (4 listed)
- patients on anti-platelet, anticoagulant or B blocker drugs
- Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function
- history of allergy to local anesthesia or opioid analgesia,
- pregnancy.
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 |
|---|---|---|
| general anesthesiageneral anesthesia | Procedure or surgery | Group C:, Group R:, group S |
| general anesthesia plus Rhomboid intercostal blockthe patients will be positioned in lateral decubitus with moving the scapula laterally by abducting the ipsilateral arm across the chest. under complete aseptic situations A high-frequency (6-12 MHz) linear US probe will be put medial to the medial border of the scapula in an oblique sagittal plane with the orientation marker directed cranially.at the T6-7 level, the tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection of 25mL of bupivacaine (0.25%) will be administered via 18-gauge Tuohy advanced in plane from a superomedial to an inferolateral direction, followed by general anesthesia | Procedure or surgery | Group R: |
| Serratus anterior plane blockThe patient will be positioned supine with his arm abducts at 90°. the US high frequency (6-12 MHz) linear probe of sonosite M turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be put in sagittal plane at the midaxillary line. identification of the fascial plane between the serratus anterior muscle and external intercostal muscles will be performed between the fourth and fifth ribs in the midaxillary area . At this point the18-gauge Tuohy needle will be advanced in plane with injection of 25mL of 0.25 %, bupivacaine. followed by general anesthesia | Procedure or surgery | group S |
Primary outcome
tramadol consumption
Time frame: at 24 hours postoperative
The amount of tramadol consumption
4 secondary outcomes
Time of performance of block
Time frame: time from positioning of ultrasound porbe till the end of block procedure.
Time to first dose of rescue analgesia
Time frame: during the first 24 hours postoperatively
Anticipated side effect
Time frame: at 24 hous post operative
Post operative patient's satisfaction
Time frame: at 24 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Heba M Fathi principal investigator
faculty of human medicine ,zagazig 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 general anesthesia, general anesthesia plus Rhomboid intercostal block and Serratus anterior plane block in people with Postoperative Pain, run by Zagazig 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 5 inclusion and 4 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 6 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba M Fathi, M.D (01000143938, heba_elgendi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tramadol consumption (time frame: at 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 6 Sep 2023.