AnalgesiaNCT06225895
Bilateral Rhomboid Intercostal Block for Perioperative Analgesia in Patients Undergoing Bilateral Reduction Mammoplasty
A study testing general anesthesia, Erector spinae plane block and a rhomboid intercostal nerve block in people with Analgesia, run by Zagazig University at 2 sites in Egypt.
Trial summary
Bilateral reduction mammoplasty is one of the most commonly performed breast surgery. The Postoperative pain following it should be minimized. Opioid administration for acute pain after reduction mammoplasty surgery has many side effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- general anesthesia, Erector spinae plane block and a rhomboid intercostal nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2024to 1 Sep 2024
- 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
- Patient acceptance.
- Age 18-65 years old.
- BMI ≤ 35 kg/m2
- ASA I - II.
- Elective bilateral reduction mammoplasty surgery under general anesthesia.
- Duration of surgery within five hours
Who cannot join
- Patients on anti-platelet, anticoagulant, or B blocker drugs.
- Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma
- History of allergy to the local anesthetics (LA) agents used in this study,
- Skin lesion at the needle insertion site,
- Those with bleeding disorders, sepsis, liver disease, psychiatric disorders, and pregnancy.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of medicine, zagazig university
Zagazig, Alsharqia, 4115
Shereen E Abd Ellatif
Zagazig, Alsharqia, 4115
About this study
Official title: Bilateral Rhomboid Intercostal Block Versus Erector Spinae Plane Block for Perioperative Analgesia in Patients Undergoing Bilateral Reduction Mammoplasty
Bilateral reduction mammoplasty is one of the most commonly performed breast surgery. The Postoperative pain following it should be minimized.
Opioid administration for acute pain after reduction mammoplasty surgery has many side effects. Regional block techniques such as paravertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.
The new alternative regional techniques such as erector spinae plane block and rhomboid intercostal plane block are clinical trials for providing a safe, easy, and painless anesthetic procedure with adequate postoperative analgesia for a large section of patients undergoing thoracic surgeries.
Read the detailed description
Reduction mammoplasty is the gold standard procedure for symptomatic breast hypertrophy and it is also used for contralateral breast symmetrisation following breast cancer surgery. Symptomatic hypermastia affects the quality of life of millions of women worldwide. The most frequent symptoms shown by more than two-thirds of patients are shoulder grooving, and back, shoulder, and neck pain. Reduction mammoplasty proved to be an effective treatment, both aesthetically and functionally, with a demonstrated consistently high patient satisfaction.
Optimal pain management is an essential component of enhanced recovery after surgery protocols that are becoming standard of care because they have been shown to reduce postoperative complications and expedite recovery. However, postoperative pain is still inadequately managed. Opioids remain the mainstay of perioperative pain management, despite well-recognized adverse events including nausea, vomiting, pruritus, and respiratory depression.
Regional anesthesia has been believed as one of the formats for effective perioperative pain control. Plane blocks such as the serratus anterior plane (SAP) block, pectoral nerve block, and erector spinae plane block have gained popularity during multimodal analgesia after various surgical procedures.
The erector spinae plane block (ESPB) was initially introduced by Forero et al. in 2016 and offers extensive analgesia in thoracic surgery. It can be used as a substitute for PVB because it is less intrusive, simpler, and safer to apply plane blocks that are applied in the plane of the spine's erector muscles.
Rhomboid intercostal block (RIB) was described in 2016 as an alternative to thoracic epidural analgesia. The local anesthetic agent is delivered into the plane between the rhomboid major and intercostal muscles. That provides good analgesia for the anterior and posterior hemithorax.
- Conditions
- Analgesia
- Being tested
- general anesthesia, Erector spinae plane block, a rhomboid intercostal nerve block, Bupivacaine
- Keywords
- Rhomboid Intercostal Block, Erector Spinae Plane Block, Reduction Mammoplasty, Analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaProcedure or surgery
patients will receive general anesthesia.
Erector spinae plane blockProcedure or surgery
patients will receive Erector spinae plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.
a rhomboid intercostal nerve blockProcedure or surgery
patients will receive a rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.
BupivacaineDrug
20 ml of bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | patients will receive general anesthesia Receives: Procedure: general anesthesia |
| E group | Active comparator | patients will receive Erector spinae plane block Receives: Procedure: general anesthesia; Procedure: Erector spinae plane block; Drug: Bupivacaine |
| R group | Active comparator | patients will receive rhomboid intercostal nerve block Receives: Procedure: general anesthesia; Procedure: a rhomboid intercostal nerve block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first dose of rescue analgesia
is the time from the end of operation to patient reporting VAS ≥ 3. Thereafter, rescue analgesia in the form of 0.1mg/kg IV of nalbuphine will be injected.
Measured: in the first postoperative 24 hours
Total nalbuphine consumption
total dose of nalbuphine rescue analgesic that the patient required postoperatively
Measured: in the first 24 hours postoperatively
Secondary outcomes (2)
changes of pain assessment
visual analogue scale will be recorded at rest and movement
Measured: at 1hour, 3,6,12, 24 hours postoperatively
non invasive blood pressure
changes of hemodynamics
Measured: immediately prior to surgery, immediately after skin incision, 15,30,60,120,180,240 min intraoperatively and at end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Model description
- computer generating random numbers, the patients will be allocated into three equal groups: Group C: (control group) patients will receive general anesthesia. Group E: patients will receive an Erector spinea plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia. Group R: patients will receive rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shereen Elsayed Abd Ellatif, Zagazig University
- Investigators
- Shereen E Abd Ellatif, M.D., Principal investigator, Faculty of medicine, zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225895
- Sponsor's protocol ID
- 11408//15-1-2024
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Gad M, Abdelwahab K, Abdallah A, Abdelkhalek M, Abdelaziz M. Ultrasound-Guided Erector Spinae Plane Block Compared to Modified Pectoral Plane Block for Modified Radical Mastectomy Operations. Anesth Essays Res. 2019 Apr-Jun;13(2):334-339. doi: 10.4103/aer.AER_77_19.
PubMed 31198256Viscardi JA, Oranges CM, Schaefer DJ, Kalbermatten DF. Reduction Mammoplasty: A Ten-Year Retrospective Review of the Omega Resection Pattern Technique. J Clin Med. 2021 Sep 27;10(19):4418. doi: 10.3390/jcm10194418.
PubMed 34640438Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.
PubMed 27291611Tunay DL, Ilginel MT, Karacaer F, Biricik E, Tabakan I, Ozmete O. Bilateral Ultrasound-Guided Erector Spinae Plane Block for Perioperative Analgesia in Breast Reduction Surgery: A Prospective Randomized and Controlled Trial. Aesthetic Plast Surg. 2023 Aug;47(4):1279-1288. doi: 10.1007/s00266-023-03315-0. Epub 2023 Mar 16.
PubMed 36928313Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.
PubMed 30851503Abd Ellatif SE, Wahdan RA, Wahdan RA, Ibrahim ES, Galal Eldin AM. Rhomboid intercostal block versus erector spinae plane block for perioperative analgesia in patients undergoing reduction mammoplasty: a prospective randomized study. BMC Anesthesiol. 2026 Feb 6;26(1):138. doi: 10.1186/s12871-025-03567-0.
PubMed 41652322
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Rhomboid Intercostal Block Versus Erector Spinae Plane Block for Perioperative Analgesia in Patients Undergoing Bilateral Reduction Mammoplasty
- ClinicalTrials.gov ID
- NCT06225895
- Acronym / sponsor ID
- 11408//15-1-2024
- Conditions
- Analgesia
- Keywords
- Rhomboid Intercostal Block, Erector Spinae Plane Block, Reduction Mammoplasty, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 26 Jan 2024 (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.
Bilateral reduction mammoplasty is one of the most commonly performed breast surgery. The Postoperative pain following it should be minimized.
Opioid administration for acute pain after reduction mammoplasty surgery has many side effects. Regional block techniques such as paravertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.
The new alternative regional techniques such as erector spinae plane block and rhomboid intercostal plane block are clinical trials for providing a safe, easy, and painless anesthetic procedure with adequate postoperative analgesia for a large section of patients undergoing thoracic surgeries.
Detailed description
Reduction mammoplasty is the gold standard procedure for symptomatic breast hypertrophy and it is also used for contralateral breast symmetrisation following breast cancer surgery. Symptomatic hypermastia affects the quality of life of millions of women worldwide. The most frequent symptoms shown by more than two-thirds of patients are shoulder grooving, and back, shoulder, and neck pain. Reduction mammoplasty proved to be an effective treatment, both aesthetically and functionally, with a demonstrated consistently high patient satisfaction.
Optimal pain management is an essential component of enhanced recovery after surgery protocols that are becoming standard of care because they have been shown to reduce postoperative complications and expedite recovery. However, postoperative pain is still inadequately managed. Opioids remain the mainstay of perioperative pain management, despite well-recognized adverse events including nausea, vomiting, pruritus, and respiratory depression.
Regional anesthesia has been believed as one of the formats for effective perioperative pain control. Plane blocks such as the serratus anterior plane (SAP) block, pectoral nerve block, and erector spinae plane block have gained popularity during multimodal analgesia after various surgical procedures.
The erector spinae plane block (ESPB) was initially introduced by Forero et al. in 2016 and offers extensive analgesia in thoracic surgery. It can be used as a substitute for PVB because it is less intrusive, simpler, and safer to apply plane blocks that are applied in the plane of the spine's erector muscles.
Rhomboid intercostal block (RIB) was described in 2016 as an alternative to thoracic epidural analgesia. The local anesthetic agent is delivered into the plane between the rhomboid major and intercostal muscles. That provides good analgesia for the anterior and posterior hemithorax.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- computer generating random numbers, the patients will be allocated into three equal groups: Group C: (control group) patients will receive general anesthesia. Group E: patients will receive an Erector spinea plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia. Group R: patients will receive rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Procedure: general anesthesiapatients will receive general anesthesia |
| E group | Active comparator | Procedure: general anesthesia, Procedure: Erector spinae plane block, Drug: Bupivacainepatients will receive Erector spinae plane block |
| R group | Active comparator | Procedure: general anesthesia, Procedure: a rhomboid intercostal nerve block, Drug: Bupivacainepatients will receive rhomboid intercostal nerve block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient acceptance.
- Age 18-65 years old.
- BMI ≤ 35 kg/m2
- ASA I - II.
- Elective bilateral reduction mammoplasty surgery under general anesthesia.
Key exclusion criteria (5 listed)
- Patients on anti-platelet, anticoagulant, or B blocker drugs.
- Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma
- History of allergy to the local anesthetics (LA) agents used in this study,
- Skin lesion at the needle insertion site,
- Those with bleeding disorders, sepsis, liver disease, psychiatric disorders, and 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 anesthesiapatients will receive general anesthesia. | Procedure or surgery | E group, R group, control group |
| Erector spinae plane blockpatients will receive Erector spinae plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia. | Procedure or surgery | E group |
| a rhomboid intercostal nerve blockpatients will receive a rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia. | Procedure or surgery | R group |
| Bupivacaine20 ml of bupivacaine 0.25% | Drug | E group, R group |
Primary outcome
Time to first dose of rescue analgesia
Time frame: in the first postoperative 24 hours
is the time from the end of operation to patient reporting VAS ≥ 3. Thereafter, rescue analgesia in the form of 0.1mg/kg IV of nalbuphine will be injected.
Total nalbuphine consumption
Time frame: in the first 24 hours postoperatively
total dose of nalbuphine rescue analgesic that the patient required postoperatively
2 secondary outcomes
changes of pain assessment
Time frame: at 1hour, 3,6,12, 24 hours postoperatively
non invasive blood pressure
Time frame: immediately prior to surgery, immediately after skin incision, 15,30,60,120,180,240 min intraoperatively and at end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 31198256Gad M, Abdelwahab K, Abdallah A, Abdelkhalek M, Abdelaziz M. Ultrasound-Guided Erector Spinae Plane Block Compared to Modified Pectoral Plane Block for Modified Radical Mastectomy Operations. Anesth Essays Res. 2019 Apr-Jun;13(2):334-339. doi: 10.4103/aer.AER_77_19.
- Background: PubMed 34640438Viscardi JA, Oranges CM, Schaefer DJ, Kalbermatten DF. Reduction Mammoplasty: A Ten-Year Retrospective Review of the Omega Resection Pattern Technique. J Clin Med. 2021 Sep 27;10(19):4418. doi: 10.3390/jcm10194418.
- Background: PubMed 27291611Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.
- Background: PubMed 36928313Tunay DL, Ilginel MT, Karacaer F, Biricik E, Tabakan I, Ozmete O. Bilateral Ultrasound-Guided Erector Spinae Plane Block for Perioperative Analgesia in Breast Reduction Surgery: A Prospective Randomized and Controlled Trial. Aesthetic Plast Surg. 2023 Aug;47(4):1279-1288. doi: 10.1007/s00266-023-03315-0. Epub 2023 Mar 16.
- Background: PubMed 30851503Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.
- Derived from this study: PubMed 41652322Abd Ellatif SE, Wahdan RA, Wahdan RA, Ibrahim ES, Galal Eldin AM. Rhomboid intercostal block versus erector spinae plane block for perioperative analgesia in patients undergoing reduction mammoplasty: a prospective randomized study. BMC Anesthesiol. 2026 Feb 6;26(1):138. doi: 10.1186/s12871-025-03567-0.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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.
Shereen E Abd Ellatif, M.D. principal investigator
Faculty of medicine, zagazig 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 general anesthesia, Erector spinae plane block and a rhomboid intercostal nerve block in people with Analgesia, run by Zagazig University 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first dose of rescue analgesia (time frame: in the first postoperative 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06225895, which also lists 6 linked publications.
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 17 Jul 2025.