Open Nephrectomy SurgeryNephrectomyNCT06983249
Rhomboid Intercostal and Subserratus Plane Block Versus Quadratus Lumborum Block in Management of Postoperative Pain After Open Nephrectomy
A study testing Rhomboid intercostal and Sub-serratus nerve block in nephrectomy and Quadratus lumborum nerve block in nephrectomy in people with Open Nephrectomy Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
Rhomboid intercostal block (RIB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after abdominal surgeries. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Open Nephrectomy Surgery
- What is being tested?
- Rhomboid intercostal and Sub-serratus nerve block in nephrectomy and Quadratus lumborum nerve block in nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 1 Sep 2026
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing open nephrectomy.
- ASA physical status II, III
- Sex (males and females)
- Age 40-70 years
Who cannot join
- Patient refusal or with difficulties in comprehending visual analogue scale (VAS) pain scores
- Any contraindications for regional anesthesia. (eg: coagulopathy, use of anticoagulants or antiplatelets...)
- Hypersensitivity to local anesthetics.
- Infection near site of injection.
Trial locations and contacts
1 site in 1 country.
About this study
Rhomboid intercostal block (RIB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after abdominal surgeries.
For achieving proper postoperative analgesia, multimodal regimens have been described for patients undergoing abdominal procedures like cholecystectomy. These multimodal regimens could include opioid medications, non-opioid analgesics (e.g., acetaminophen and ketorolac), and regional blocks. These modalities could be used alone or in combination. This prospective randomised controlled trial was performed to analyse the postoperative analgesic effects of ultrasound guided Quadratus lumborum block and RISS block in managing post operative pain in patients undergoing open nephrectomy.
Read the detailed description
Open nephrectomy is an important surgery in treatment of patients with renal cancer, ultrasound guidance is rapidly becoming the gold standard for regional anesthesia. There is an evidence matched with improving technology to show that the use of ultrasound has significant benefits over conventional techniques, such as nerve stimulation and loss of resistance. The improved safety and efficacy that ultrasound brings to regional anesthesia helped promote its use and realize the benefits that regional anesthesia has over general anesthesia, such as decreased morbidity and mortality, superior post-operative analgesia, cost-effectiveness, decreased postoperative complications and an improved postoperative course .
The Rhomboid intercostal and subserratus plane block (RISS) is a relatively newer block technique described by Elsharkawy et al.
The RISS provides analgesia for the regions supplied by T3 - T6 thoracic nerves, analgesia of the RISS block may be due to two different mechanisms. First, the block mainly affects the thoracic intercostal dorsal rami emerging under the erector spinae muscle at the level of T3-T9, where it is attached to the transverse spinal processes. Second, the injected local anesthetic may extend to the paravertebral space under the erector spinae muscle Quadratus lumborum block (QLB) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen.
Although the concept of the block is similar to that of lateral transverses-abdominis plane block (TAPB), the extent of the effect has been suggested to be greater because the point of injection is more dorsal. Local anesthetics are administered into the space between the quadratus lumborum muscle and the medial layer of the thoracolumbar fascia to achieve QLB, which can spread to the paravertebral space .
- Conditions
- Open Nephrectomy Surgery
- Being tested
- Rhomboid intercostal and Sub-serratus nerve block in nephrectomy, Quadratus lumborum nerve block in nephrectomy
- Keywords
- Rhomboid intercostal subserratus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid intercostal and Sub-serratus nerve block in nephrectomyProcedure or surgery
Also called Rhomboid intercostal and subserratus nerve block
That block was performed when the patient was in the lateral position. A high frequency linear ultrasound transducer was placed longitudinally on the patient's back, just 2 cm medial to the medial scapular border. Then, the probe was slightly rotated to obtain an oblique parasagittal plane. The following landmarks were identified: the trapezius muscle, rhomboid major muscle, intercostal muscles, pleura, and lungs (from superficial to deep in order of appearance). Under ultrasound guidance, a 22 mm gauge spinal needle was directed to the plane by using high frequency ultrasound guidence (Sono SiteTM, Inc., Bothell, WA 98021, USA) between the rhomboid major and the underlying intercostal muscles and 15 ml bupivacaine (0.25%) was delivered into that plane (after repeated negative aspiration of blood), and its spread was manifested by the hydrodissection and widening of the plane visualized by ultrasound
Quadratus lumborum nerve block in nephrectomyProcedure or surgery
Also called QLB
Ultrasound guided posterior quadrates lumborum block was done in lateral decubitus position and linear probe according to the depth was placed in the midaxillary line in the transverse plane immediately above the iliac crest and then it was slided dorsally until the "Shamrock sign" was clearly identified. In "Shamrock sign" The quadratus lumborum (QL) muscle is seen as a superior leaf of the Shamrock at the apex of the transverse process (TP) of L4
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum nerve block in nephrectomy | Experimental | Qudaratus lumborum nerve block ultrasound guided in nephrectomy Receives: Procedure: Quadratus lumborum nerve block in nephrectomy |
| Rhomboid intercostal and Sub-serratus nerve block in nephrectomy | Experimental | Rhomboid intercostal and subserratus nerve block ultrasound guided Receives: Procedure: Rhomboid intercostal and Sub-serratus nerve block in nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Primary outcome:
Time of first post operative analgesic demand
Measured: One year
Secondary outcomes (1)
Secondary outcome
-Total analgesic requirement with a rescue analgesic (IV fentanyl 0.5 mic\kg) was given if the patient had a VAS of 4 or more over 0-24, 24-48, and 48-72 h after surgery.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jul 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Open Nephrectomy SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The eligible patients will be enrolled in this double blinded study and randomly allocated into one of two parrallel equal groups (25 patients in each group) according to sample size by computer generated random number list. The allocation will be concealed, the data will blind to the study group. Two persons should be blinded; the patient and the investigator who will monitor the patients. Groups: Patients will be assigned randomly into two equal groups: Group (A): patients will receive RISS block under ultrasound guide 30 ml bupivacaine 0.25%. Group B "Quadratus lumborum block": patients will Receive ultra sound guided Quadratus Lumborum block using 20 ml Bupivacaine 0.25% on operated side.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983249
- Sponsor's protocol ID
- MD186/2024
- Acronym
- Nephrectomy
- Status last verified
- Sep 2024
- First submitted
- 28 Nov 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Compare between RISS nerve block versus QLB nerve block in management of post operative pain after nephrectomy
Publications
Elsharkawy H, Hamadnalla H, Altinpulluk EY, Gabriel RA. Rhomboid intercostal and subserratus plane block -a case series. Korean J Anesthesiol. 2020 Dec;73(6):550-556. doi: 10.4097/kja.19479. Epub 2020 Feb 12.
PubMed 32046475West D. Evaluation of rhomboid intercostal and subserratus plane block under direct vision for postoperative analgesia in thoracic surgeries: a prospective, randomized controlled trial, thoracic non-oncologic. Eur J Cardiothorac Surg. 2022 Nov 3;62(6):ezac532. doi: 10.1093/ejcts/ezac532. No abstract available.
PubMed 36367247Kozanhan B, Semerkant T, Esme H, Canitez A, Iyisoy MS. Evaluation of rhomboid intercostal and subserratus plane block under direct vision for postoperative analgesia in thoracic surgeries: a prospective, randomized controlled trial. Eur J Cardiothorac Surg. 2022 Nov 3;62(6):ezac498. doi: 10.1093/ejcts/ezac498.
PubMed 36218395
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhomboid Intercostal and Subserratus Plane Block Versus Quadratus Lumborum Block in Management of Postoperative Pain After Open Nephrectomy
- ClinicalTrials.gov ID
- NCT06983249
- Acronym / sponsor ID
- Nephrectomy / MD186/2024
- Conditions
- Open Nephrectomy Surgery
- Keywords
- Rhomboid intercostal subserratus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 21 May 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.
Rhomboid intercostal block (RIB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after abdominal surgeries.
For achieving proper postoperative analgesia, multimodal regimens have been described for patients undergoing abdominal procedures like cholecystectomy. These multimodal regimens could include opioid medications, non-opioid analgesics (e.g., acetaminophen and ketorolac), and regional blocks. These modalities could be used alone or in combination. This prospective randomised controlled trial was performed to analyse the postoperative analgesic effects of ultrasound guided Quadratus lumborum block and RISS block in managing post operative pain in patients undergoing open nephrectomy.
Detailed description
Open nephrectomy is an important surgery in treatment of patients with renal cancer, ultrasound guidance is rapidly becoming the gold standard for regional anesthesia. There is an evidence matched with improving technology to show that the use of ultrasound has significant benefits over conventional techniques, such as nerve stimulation and loss of resistance. The improved safety and efficacy that ultrasound brings to regional anesthesia helped promote its use and realize the benefits that regional anesthesia has over general anesthesia, such as decreased morbidity and mortality, superior post-operative analgesia, cost-effectiveness, decreased postoperative complications and an improved postoperative course .
The Rhomboid intercostal and subserratus plane block (RISS) is a relatively newer block technique described by Elsharkawy et al.
The RISS provides analgesia for the regions supplied by T3 - T6 thoracic nerves, analgesia of the RISS block may be due to two different mechanisms. First, the block mainly affects the thoracic intercostal dorsal rami emerging under the erector spinae muscle at the level of T3-T9, where it is attached to the transverse spinal processes. Second, the injected local anesthetic may extend to the paravertebral space under the erector spinae muscle Quadratus lumborum block (QLB) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen.
Although the concept of the block is similar to that of lateral transverses-abdominis plane block (TAPB), the extent of the effect has been suggested to be greater because the point of injection is more dorsal. Local anesthetics are administered into the space between the quadratus lumborum muscle and the medial layer of the thoracolumbar fascia to achieve QLB, which can spread to the paravertebral space .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The eligible patients will be enrolled in this double blinded study and randomly allocated into one of two parrallel equal groups (25 patients in each group) according to sample size by computer generated random number list. The allocation will be concealed, the data will blind to the study group. Two persons should be blinded; the patient and the investigator who will monitor the patients. Groups: Patients will be assigned randomly into two equal groups: Group (A): patients will receive RISS block under ultrasound guide 30 ml bupivacaine 0.25%. Group B "Quadratus lumborum block": patients will Receive ultra sound guided Quadratus Lumborum block using 20 ml Bupivacaine 0.25% on operated side.
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum nerve block in nephrectomy | Experimental | Procedure: Quadratus lumborum nerve block in nephrectomyQudaratus lumborum nerve block ultrasound guided in nephrectomy |
| Rhomboid intercostal and Sub-serratus nerve block in nephrectomy | Experimental | Procedure: Rhomboid intercostal and Sub-serratus nerve block in nephrectomyRhomboid intercostal and subserratus nerve block ultrasound guided |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing open nephrectomy.
- ASA physical status II, III
- Sex (males and females)
- Age 40-70 years
Key exclusion criteria (4 listed)
- Patient refusal or with difficulties in comprehending visual analogue scale (VAS) pain scores
- Any contraindications for regional anesthesia. (eg: coagulopathy, use of anticoagulants or antiplatelets...)
- Hypersensitivity to local anesthetics.
- Infection near site of injection.
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 and Sub-serratus nerve block in nephrectomyAlso: Rhomboid intercostal and subserratus nerve blockThat block was performed when the patient was in the lateral position. A high frequency linear ultrasound transducer was placed longitudinally on the patient's back, just 2 cm medial to the medial scapular border. Then, the probe was slightly rotated to obtain an oblique parasagittal plane. The following landmarks were identified: the trapezius muscle, rhomboid major muscle, intercostal muscles, pleura, and lungs (from superficial to deep in order of appearance). Under ultrasound guidance, a 22 mm gauge spinal needle was directed to the plane by using high frequency ultrasound guidence (Sono SiteTM, Inc., Bothell, WA 98021, USA) between the rhomboid major and the underlying intercostal muscles and 15 ml bupivacaine (0.25%) was delivered into that plane (after repeated negative aspiration of blood), and its spread was manifested by the hydrodissection and widening of the plane visualized by ultrasound | Procedure or surgery | Rhomboid intercostal and Sub-serratus nerve block in nephrectomy |
| Quadratus lumborum nerve block in nephrectomyAlso: QLBUltrasound guided posterior quadrates lumborum block was done in lateral decubitus position and linear probe according to the depth was placed in the midaxillary line in the transverse plane immediately above the iliac crest and then it was slided dorsally until the "Shamrock sign" was clearly identified. In "Shamrock sign" The quadratus lumborum (QL) muscle is seen as a superior leaf of the Shamrock at the apex of the transverse process (TP) of L4 | Procedure or surgery | Quadratus lumborum nerve block in nephrectomy |
Primary outcome
Primary outcome
Time frame: One year
Primary outcome: Time of first post operative analgesic demand
1 secondary outcome
Secondary outcome
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 32046475Elsharkawy H, Hamadnalla H, Altinpulluk EY, Gabriel RA. Rhomboid intercostal and subserratus plane block -a case series. Korean J Anesthesiol. 2020 Dec;73(6):550-556. doi: 10.4097/kja.19479. Epub 2020 Feb 12.
- Background: PubMed 36367247West D. Evaluation of rhomboid intercostal and subserratus plane block under direct vision for postoperative analgesia in thoracic surgeries: a prospective, randomized controlled trial, thoracic non-oncologic. Eur J Cardiothorac Surg. 2022 Nov 3;62(6):ezac532. doi: 10.1093/ejcts/ezac532. No abstract available.
- Background: PubMed 36218395Kozanhan B, Semerkant T, Esme H, Canitez A, Iyisoy MS. Evaluation of rhomboid intercostal and subserratus plane block under direct vision for postoperative analgesia in thoracic surgeries: a prospective, randomized controlled trial. Eur J Cardiothorac Surg. 2022 Nov 3;62(6):ezac498. doi: 10.1093/ejcts/ezac498.
- Individual participant dataSharing planned: No. Compare between RISS nerve block versus QLB nerve block in management of post operative pain after nephrectomy
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Sub-serratus nerve block in nephrectomy and Quadratus lumborum nerve block in nephrectomy in people with Open Nephrectomy Surgery, run by Ain Shams 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 4 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 11 Sep 2025. 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?
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?
Primary outcome (time frame: One year). 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 NCT06983249, which also lists 3 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 11 Sep 2025.