Pain, PostoperativeNCT06781346
Rhomboid Intercostal Block Compared With Thoracic Paravertebral Block in Breast Cancer Surgeries
A study testing Rhomboid Intercostal Block and Thoracic Paravertebral Block in people with Pain, Postoperative, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Postoperative pain is a significant problem following breast surgery . If not treated in time, it may lead to delayed wound healing, respiratory depression, hemodynamic disorders, anxiety,other complications, and finally lead to difficult recovery of patients . Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Rhomboid Intercostal Block and Thoracic Paravertebral Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2025to 15 Dec 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older .
- American Society of Anesthesiologists (ASA) II-lll Scheduled for elective breast surgery for modified radical mastectomy, simple mastectomy, breast conservative surgery.
Who cannot join
- Patient refusal.
- Significant renal, hepatic and cardiovascular diseases.
- History of allergy to one of the study drugs.
- Any contraindication to regional anesthesia such as local infection or bleeding disorders.
- Chronic opioid use, history of chronic pain and cognitive disorders.
- Emergent surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Rhomboid Intercostal Block Compared With Thoracic Paravertebral Block in Adult Patients Undergoing Breast Cancer Surgeries: A Randomized Controlled Double-blinded Study
Postoperative pain is a significant problem following breast surgery . If not treated in time, it may lead to delayed wound healing, respiratory depression, hemodynamic disorders, anxiety,other complications, and finally lead to difficult recovery of patients . Therefore, the prevention of postoperative pain is of great importance for patients.
Opioids, while effective in pain management, are linked to a spectrum of adverse effects, including respiratory depression, post-operative nausea and vomiting, pruritus and constipation. The adoption of multimodal analgesia following breast cancer surgery emerges as a pivotal strategy to mitigate the complications associated with opioid use in the postoperative period.[4] US-guided rhomboid intercostal block (US-RIB) is a new fascial block technique discovered by Elsharkawy et al in 2016.
Read more
Injection of local anaesthetic into the fascial plane between rhomboid major and intercostal muscles provided analgesia for both the anterior and posterior hemithorax,targets the lateral cutaneous branches of the ventral rami of the thoracic intercostal nerves from T2 to T9.
Some clinical studies have reported that RIB can effectively reduce postoperative pain, reduce opioid consumption and improve the quality of recovery in patients with breast cancer surgeries .
The ultrasound guided Thoracic paravertebral (TPV) block in the context of breast cancer surgery has been reported to decrease postoperative pain score up to 72 hours, reduce opioid consumption, improve the quality of recovery, and suppress the development or decrease the severity of chronic pain by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL).
In our study investigators hypothesized that the Rhomboid Intercostal block (RIB) can provide an effective analgesia comparable with thoracic paravertebral (TPV) block without the necessity to approach the pleura and the attendant risks in adult patients undergoing Breast cancer surgeries.
Read the detailed description
After approval of the local institutional ethics committee and local institutional review board. Patients who are scheduled for elective breast cancer surgeries and fulfilling the inclusion criteria in Fayoum university hospital starting from june 2024 will be enrolled in this randomized controlled study until fulfilling sample size. A detailed informed consent will be signed by the eligible participants before recruitment.
The patients will be randomized into two groups: RI block group and TPV block group in a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided Rl and TPV block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection will be blinded from the group assignments.
ANESTHETIC TECHNIQUE In this study,. All patients will be monitored using electrocardiography, pulse-oximetry, capnography,Non invasive Blood Pressure for blood pressure monitoring in the operating room.
After pre-oxygenation, general anesthesia will be induced with intravenous propofol (2 mg/kg) and fentanyl (1 μg/kg). After muscle relaxation with atracurium (0.5mg/kg), tracheal intubation will be performed by a cuffed endotracheal tube ,mechanical ventilation will be adjusted to maintain the end-tidal Carbon dioxide between 30 and 35 mmHg. Maintenance of anesthesia will be made using IV atracurium and inhalational anesthesia (isoflurane) starting at one minimal alveolar concentration (MAC) and will be adjusted to obtain an adequate level of anesthesia by titrating the concentration according to the BIS monitoring (BIS Complete Monitoring System P/N 185-0151 Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048 USA) to keep the BIS value between 40 and 60.
After induction , the patient will be placed in the lateral decubitus position. The same anesthesiologist will perform the block.
In both groups, the T1-T12 thoracic spinal levels will be sonographically identified using a high frequency linear US probe (HFL_50, 15_6MHz). Then the probe will be placed vertically and nearly 3 cm lateral to the spinous process at the thoracic level T4/T5. The paraspinal muscles (erector spinae, trapezius, rhomboid), transverse processes , superior costo-transverse ligament (SCTL) and parietal pleura will be all identified under parasagittal scanning.
In RI block group, A 22 G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique. The intravascular injection should be confirmed negative through aspiration, and 1-3 ml of normal saline was injected to divide the rhomboid and intercostal muscle, and a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected After negative aspiration of blood or air, injected into the deep layer of the rhomboid muscle.
In the TPV block group , the transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards.
After 15 min , an incision will be made to perform the surgical procedure. . Continuous hemodynamic monitoring of blood pressure and heart rate will be done . If the systolic blood pressure decreased to a 20% below the baseline, 5 mg of ephedrine will be injected IV. Moreover, if the heart rate reduced to a 50 beat per minute or less , 0.5 mg of atropine will be injected IV.
Intraoperative if blood pressure increases over 20% of baseline and BIS value is between 40-60 we will give fentanyl (1 μg/kg)
At the end of the surgery, isoflurane will be discontinued and the muscle relaxant will be antagonized with neostigmine (0.04-0.08 mg/kg) and atropine (0.01 mg/kg) and will be extubated when the patient meets the following criteria: awake or arousable, hemodynamically stable, no ongoing active bleeding and warm extremities , after the return of spontaneous respiration.
At post anesthesia care unit all patients will be monitored blood pressure , heart rate and oxygen saturation , The patient's pain will be evaluated using a Visual Analog Scale (VAS) Both during rest and with cough (0: no pain, 10: worst pain ever) at time zero (postoperative when patient is fully conscious and can assess and evaluate pain) if there is pain patient will receive ketorolac 30mg IV and Paracetamol 1 gm IV
After admission at ward at the end of surgery, all patients will receive IV fentanyl via patient controlled analgesia (PCA) with concentration 10 μg/ml , with bolus 15 μg and lockout interval 10 minutes and maximum dose of 90 μg/hr with no background dose for 24 hours. Paracetamol 1 gm IV will be given every 8 hours.. The patient's pain will be evaluated using a Visual Analog Scale (VAS) (0: no pain, 10: worst pain ever) at time intervals: Time zero (when patient is fully conscious and can assess and evaluate the pain) then 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24h postoperative.
- Conditions
- Pain, Postoperative
- Being tested
- Rhomboid Intercostal Block, Thoracic Paravertebral Block
- Keywords
- Rhomboid Intercostal block, Breast surgery
- 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 BlockProcedure or surgery
In RI block group, A 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique. The intravascular injection should be confirmed negative through aspiration, and 1-3 ml of normal saline was injected to divide the rhomboid and intercostal muscle, and a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected After negative aspiration of blood or air, injected into the deep layer of the rhomboid muscle.
Thoracic Paravertebral BlockProcedure or surgery
In the TPV block group , the transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards.
| Study group | Role | What they receive |
|---|---|---|
| Rhomboid intercostal block | Experimental | A 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique. Receives: Procedure: Rhomboid Intercostal Block |
| Thoracic paravertebral block | Active comparator | the transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. Receives: Procedure: Thoracic Paravertebral Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total postoperative fentanyl consumption in the first 24 hours. (μg)
The total postoperative fentanyl consumption in the first 24 hours. (μg)
Measured: in the first 24 hours.
Secondary outcomes (8)
Total intraoperative fentanyl
Total intraoperative fentanyl
Measured: Intraoperative
Blood pressure
Blood pressure intraoperative
Measured: 24 hours postoperative
Time to first analgesic request
Postoperative
Measured: 24 hours postoperative
VAS score
Both during rest and with cough (score 0 =no pain and 10 =worst pain ever) in the two groups of the study
Measured: 24 hours postoperative
Complications related to the block : pleural puncture , vascular puncture and local anesthesia systemic toxicity.
Intraoperative
Measured: Intraoperative
Complications related to IV opioids
nausea and vomiting (0 = no symptoms, 1 = only nausea, 2 = nausea and vomiting), respiratory depression (respiratory rate less than 10), sedation (0 = awake and alert, 1 = quietly awake, 2 = asleep but easily arousable, 3 = deep sleep, responding to painful stimulus), pruritus(0=no symptoms, 1=mild pruritus, 2 moderate pruritus, 3 sever pruritus)
Measured: 24 hours postoperative
Hospital length of stay
Postoperative
Measured: 24 hours Postoperative
Participant satisfaction will be assessed on a 4-point scale (1:excellent , 2: good 3: fair, 4: poor).
Postoperative
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 posted17 Jan 2025
- Study start15 Feb 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahdy Ahmed Abd Elhady, Fayoum University Hospital
- Investigators
- Mahdy A Abd El-hady, MD, Principal investigator, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781346
- Sponsor's protocol ID
- M 729
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsharkawy 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 27291611Tulgar S, Selvi O, Thomas DT, Manukyan M, Ozer Z. Rhomboid intercostal block in a modified radical mastectomy and axillary curettage patient; A new indication for novel interfascial block. J Clin Anesth. 2019 May;54:158-159. doi: 10.1016/j.jclinane.2018.12.006. Epub 2018 Dec 13. No abstract available.
PubMed 30553225Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.
PubMed 31176954Tulgar S, Kiziltunc B, Thomas DT, Manukyan MN, Ozer Z. The combination of modified pectoral nerves block and rhomboid intercostal block provides surgical anesthesia in breast surgery. J Clin Anesth. 2019 Dec;58:44. doi: 10.1016/j.jclinane.2019.04.040. Epub 2019 May 7. No abstract available.
PubMed 31075623Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.
PubMed 26431130
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Rhomboid Intercostal Block Compared With Thoracic Paravertebral Block in Adult Patients Undergoing Breast Cancer Surgeries: A Randomized Controlled Double-blinded Study
- ClinicalTrials.gov ID
- NCT06781346
- Acronym / sponsor ID
- M 729
- Conditions
- Pain, Postoperative
- Keywords
- Rhomboid Intercostal block, Breast surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 17 Jan 2025 (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.
Postoperative pain is a significant problem following breast surgery . If not treated in time, it may lead to delayed wound healing, respiratory depression, hemodynamic disorders, anxiety,other complications, and finally lead to difficult recovery of patients . Therefore, the prevention of postoperative pain is of great importance for patients.
Opioids, while effective in pain management, are linked to a spectrum of adverse effects, including respiratory depression, post-operative nausea and vomiting, pruritus and constipation. The adoption of multimodal analgesia following breast cancer surgery emerges as a pivotal strategy to mitigate the complications associated with opioid use in the postoperative period.[4] US-guided rhomboid intercostal block (US-RIB) is a new fascial block technique discovered by Elsharkawy et al in 2016.
Injection of local anaesthetic into the fascial plane between rhomboid major and intercostal muscles provided analgesia for both the anterior and posterior hemithorax,targets the lateral cutaneous branches of the ventral rami of the thoracic intercostal nerves from T2 to T9.
Some clinical studies have reported that RIB can effectively reduce postoperative pain, reduce opioid consumption and improve the quality of recovery in patients with breast cancer surgeries .
The ultrasound guided Thoracic paravertebral (TPV) block in the context of breast cancer surgery has been reported to decrease postoperative pain score up to 72 hours, reduce opioid consumption, improve the quality of recovery, and suppress the development or decrease the severity of chronic pain by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL).
In our study investigators hypothesized that the Rhomboid Intercostal block (RIB) can provide an effective analgesia comparable with thoracic paravertebral (TPV) block without the necessity to approach the pleura and the attendant risks in adult patients undergoing Breast cancer surgeries.
Detailed description
After approval of the local institutional ethics committee and local institutional review board. Patients who are scheduled for elective breast cancer surgeries and fulfilling the inclusion criteria in Fayoum university hospital starting from june 2024 will be enrolled in this randomized controlled study until fulfilling sample size. A detailed informed consent will be signed by the eligible participants before recruitment.
The patients will be randomized into two groups: RI block group and TPV block group in a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided Rl and TPV block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection will be blinded from the group assignments.
ANESTHETIC TECHNIQUE In this study,. All patients will be monitored using electrocardiography, pulse-oximetry, capnography,Non invasive Blood Pressure for blood pressure monitoring in the operating room.
After pre-oxygenation, general anesthesia will be induced with intravenous propofol (2 mg/kg) and fentanyl (1 μg/kg). After muscle relaxation with atracurium (0.5mg/kg), tracheal intubation will be performed by a cuffed endotracheal tube ,mechanical ventilation will be adjusted to maintain the end-tidal Carbon dioxide between 30 and 35 mmHg. Maintenance of anesthesia will be made using IV atracurium and inhalational anesthesia (isoflurane) starting at one minimal alveolar concentration (MAC) and will be adjusted to obtain an adequate level of anesthesia by titrating the concentration according to the BIS monitoring (BIS Complete Monitoring System P/N 185-0151 Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048 USA) to keep the BIS value between 40 and 60.
After induction , the patient will be placed in the lateral decubitus position. The same anesthesiologist will perform the block.
In both groups, the T1-T12 thoracic spinal levels will be sonographically identified using a high frequency linear US probe (HFL_50, 15_6MHz). Then the probe will be placed vertically and nearly 3 cm lateral to the spinous process at the thoracic level T4/T5. The paraspinal muscles (erector spinae, trapezius, rhomboid), transverse processes , superior costo-transverse ligament (SCTL) and parietal pleura will be all identified under parasagittal scanning.
In RI block group, A 22 G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique. The intravascular injection should be confirmed negative through aspiration, and 1-3 ml of normal saline was injected to divide the rhomboid and intercostal muscle, and a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected After negative aspiration of blood or air, injected into the deep layer of the rhomboid muscle.
In the TPV block group , the transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards.
After 15 min , an incision will be made to perform the surgical procedure. . Continuous hemodynamic monitoring of blood pressure and heart rate will be done . If the systolic blood pressure decreased to a 20% below the baseline, 5 mg of ephedrine will be injected IV. Moreover, if the heart rate reduced to a 50 beat per minute or less , 0.5 mg of atropine will be injected IV.
Intraoperative if blood pressure increases over 20% of baseline and BIS value is between 40-60 we will give fentanyl (1 μg/kg)
At the end of the surgery, isoflurane will be discontinued and the muscle relaxant will be antagonized with neostigmine (0.04-0.08 mg/kg) and atropine (0.01 mg/kg) and will be extubated when the patient meets the following criteria: awake or arousable, hemodynamically stable, no ongoing active bleeding and warm extremities , after the return of spontaneous respiration.
At post anesthesia care unit all patients will be monitored blood pressure , heart rate and oxygen saturation , The patient's pain will be evaluated using a Visual Analog Scale (VAS) Both during rest and with cough (0: no pain, 10: worst pain ever) at time zero (postoperative when patient is fully conscious and can assess and evaluate pain) if there is pain patient will receive ketorolac 30mg IV and Paracetamol 1 gm IV
After admission at ward at the end of surgery, all patients will receive IV fentanyl via patient controlled analgesia (PCA) with concentration 10 μg/ml , with bolus 15 μg and lockout interval 10 minutes and maximum dose of 90 μg/hr with no background dose for 24 hours. Paracetamol 1 gm IV will be given every 8 hours.. The patient's pain will be evaluated using a Visual Analog Scale (VAS) (0: no pain, 10: worst pain ever) at time intervals: Time zero (when patient is fully conscious and can assess and evaluate the pain) then 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24h postoperative.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhomboid intercostal block | Experimental | Procedure: Rhomboid Intercostal BlockA 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique. |
| Thoracic paravertebral block | Active comparator | Procedure: Thoracic Paravertebral Blockthe transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older .
- American Society of Anesthesiologists (ASA) II-lll Scheduled for elective breast surgery for modified radical mastectomy, simple mastectomy, breast conservative surgery.
Key exclusion criteria (6 listed)
- Patient refusal.
- Significant renal, hepatic and cardiovascular diseases.
- History of allergy to one of the study drugs.
- Any contraindication to regional anesthesia such as local infection or bleeding disorders.
- Chronic opioid use, history of chronic pain and cognitive disorders.
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 BlockIn RI block group, A 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique. The intravascular injection should be confirmed negative through aspiration, and 1-3 ml of normal saline was injected to divide the rhomboid and intercostal muscle, and a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected After negative aspiration of blood or air, injected into the deep layer of the rhomboid muscle. | Procedure or surgery | Rhomboid intercostal block |
| Thoracic Paravertebral BlockIn the TPV block group , the transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards. | Procedure or surgery | Thoracic paravertebral block |
Primary outcome
The total postoperative fentanyl consumption in the first 24 hours. (μg)
Time frame: in the first 24 hours.
The total postoperative fentanyl consumption in the first 24 hours. (μg)
8 secondary outcomes
Total intraoperative fentanyl
Time frame: Intraoperative
Blood pressure
Time frame: 24 hours postoperative
Time to first analgesic request
Time frame: 24 hours postoperative
VAS score
Time frame: 24 hours postoperative
Complications related to the block : pleural puncture , vascular puncture and local anesthesia systemic toxicity.
Time frame: Intraoperative
Complications related to IV opioids
Time frame: 24 hours postoperative
Hospital length of stay
Time frame: 24 hours Postoperative
Participant satisfaction will be assessed on a 4-point scale (1:excellent , 2: good 3: fair, 4: poor).
Time frame: 24 hours postoperative
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 9 Sep 2026.
- 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 30553225Tulgar S, Selvi O, Thomas DT, Manukyan M, Ozer Z. Rhomboid intercostal block in a modified radical mastectomy and axillary curettage patient; A new indication for novel interfascial block. J Clin Anesth. 2019 May;54:158-159. doi: 10.1016/j.jclinane.2018.12.006. Epub 2018 Dec 13. No abstract available.
- Background: PubMed 31176954Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.
- Background: PubMed 31075623Tulgar S, Kiziltunc B, Thomas DT, Manukyan MN, Ozer Z. The combination of modified pectoral nerves block and rhomboid intercostal block provides surgical anesthesia in breast surgery. J Clin Anesth. 2019 Dec;58:44. doi: 10.1016/j.jclinane.2019.04.040. Epub 2019 May 7. No abstract available.
- Background: PubMed 26431130Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.
- Individual participant dataSharing planned: No
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Recruiting
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
Pain After Surgery, Pain and Anxiety
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.
Mahdy A Abd El-hady, MD principal investigator
Faculty of medicine, Fayoum 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 Rhomboid Intercostal Block and Thoracic Paravertebral Block in people with Pain, Postoperative, run by Fayoum University Hospital 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 2 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: finished, as of the sponsor's last update on 9 Sep 2026. 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?
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?
The total postoperative fentanyl consumption in the first 24 hours. (μg) (time frame: in the first 24 hours.). 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 NCT06781346, which also lists 5 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 9 Sep 2026.