Analgesia , Open Renal SurgeriesNCT06778707
External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block in Open Nephrectomy
A study testing External Oblique Intercostal Block and Subcostal Transversus Abdominis Plane Block in people with Analgesia , Open Renal Surgeries, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the study is to compare the analgesic efficacy of external oblique intercostal block vs subcostal transversus abdominis plane block in patients undergoing open nephrectomy. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia , Open Renal Surgeries
- What is being tested?
- External Oblique Intercostal Block and Subcostal Transversus Abdominis 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
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2025to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients who will be included in the study age from 21 to 60 years, both male and female, with American Society of Anesthesiologists (ASA) Physical Status Classification System I-III.
Who cannot join
- Any patient refuses to participate, has bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases, on chronic opioid use, with history of allergy to local anesthetics and has infection at the needle entry point will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block for Adequate Analgesia in Open Nephrectomy
The aim of the study is to compare the analgesic efficacy of external oblique intercostal block vs subcostal transversus abdominis plane block in patients undergoing open nephrectomy.
Read the detailed description
This randomized controlled double blinded study will be done on 80 patients (40 in each group), patients will be randomly classified by computer generated numbers. Through a sealed opaque envelope technique, a blinded nurse who will not participate in the study or data collection, will read the number contained in the envelope and make group assignments.
All patients will be seen in the anesthesia clinic, optimization of general condition and all required investigations will be done before surgery. Patients will be premedicated with 1.5 mg midazolam and 4 mg granisetron. Basic monitoring will be applied to the patients such as Pulse oximetry (SPO2), Non-invasive blood pressure (NIBP), Electrocardiogram (ECG), Capnogram and temperature probe.
After adequate preoxygenation, induction of general anesthesia will be done through wide bore cannula using 1 mic/kg fentanyl, 1-2 mg/kg titration of propofol, 0.5mg/kg atracurium. Patients were mechanically ventilated using volume-controlled ventilation (VCV) with adjustment of end tidal carbon dioxide (ETCO2) to be 32-35 mmHg, 50% inspired oxygen in air and sevoflurane concentration to be 1MAC. The patients will receive either block before skin incision that will be done 20 minutes after the block. 0.5 mic/kg fentanyl will be injected when heart rate or blood pressure increases more than 20% of baseline. By the end of the surgery, 1gm paracetamol will be administered with fully reversal of muscle relaxants at the end of the surgery.
Group E This group of patients will receive external oblique intercostal block in supine position. A high-frequency linear transducer will be placed in sagittal plane between the midclavicular and anterior axillary line at the level of the 6 to 8th rib. The pointing mark of the probe will be directed cranially and may be slightly tilted medially for better identification of external oblique muscle and intercostal muscles.
After sterilization of skin and through the in-plane technique directing from cranial to caudal, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.
Group T Subcostal transversus abdominis plane block will be applied to this group and patients will be supine. A high-frequency linear transducer will be placed directly below and along costal margin. After sterilization of skin, with in-plane technique and from lateral to medial, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.
After extubation, the patients will be transferred to PACU (Post-Anesthesia Care Unit) for monitoring. Numerical rating scale (NRS) will be used for pain assessment while 0 is no pain and 10 is severe agonizing pain. Patients will be given a rescue analgesia of 0.05 mg / kg morphine if NRS ≥ 4 and repeated if needed after 20 minutes. 1 gm paracetamol every 8 h and 30 mg ketorolac (if not contraindicated) every 12 h will be given regularly.
- Conditions
- Analgesia , Open Renal Surgeries
- Being tested
- External Oblique Intercostal Block, Subcostal Transversus Abdominis Plane Block
- Keywords
- External Oblique Intercostal Block, Subcostal Transversus Abdominis Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Oblique Intercostal BlockProcedure or surgery
In group E, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.
Subcostal Transversus Abdominis Plane BlockProcedure or surgery
In group T, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.
| Study group | Role | What they receive |
|---|---|---|
| group E | Active comparator | This group of patients will receive external oblique intercostal block in supine position. A high-frequency linear transducer will be placed in sagittal plane between the midclavicular and anterior axillary line at the level of the 6 to 8th rib. The pointing mark of the probe will be directed cranially and may be slightly tilted medially for better identification of external oblique muscle and intercostal muscles.
After sterilization of skin and through the in-plane technique directing from cranial to caudal, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it. Receives: Procedure: External Oblique Intercostal Block |
| group T | Active comparator | Subcostal transversus abdominis plane block will be applied to this group and patients will be supine. A high-frequency linear transducer will be placed directly below and along costal margin. After sterilization of skin, with in-plane technique and from lateral to medial, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle. Receives: Procedure: Subcostal Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption in the first postoperative 24 hour
Total morphine consumption in the first postoperative 24 hour
Measured: first postoperative 24 hour
Secondary outcomes (2)
NRS when patient reach recovery room and at 2 hour, 6 hour, 12 hour, 18 hour and 24 hour
NRS when patient reach recovery room and at 2 hour, 6 hour, 12 hour, 18 hour and 24 hour
Measured: when patient reach recovery room and at 2 hour, 6 hour, 12 hour, 18 hour and 24 hour
Total intraoperative fentanyl consumption with exclusion of fentanyl used in induction
Total intraoperative fentanyl consumption with exclusion of fentanyl used in induction
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start5 Jan 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia , Open Renal SurgeriesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Wahed Ali, Tanta University
- Investigators
- Ahmed A Abdelwahed, lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778707
- Sponsor's protocol ID
- 36264PR998/12/24
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing abstract and final paper on a medical journal
Publications
1.Bansal P, Sultania N, Mittal T. External oblique intercostal block in open nephrectomy patients-A zenith in analgesia for anterolateral upper abdominal surgeries: A case series. Asian Journal of Medical Sciences. 2024;15(2):264-8.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block for Adequate Analgesia in Open Nephrectomy
- ClinicalTrials.gov ID
- NCT06778707
- Acronym / sponsor ID
- 36264PR998/12/24
- Conditions
- Analgesia , Open Renal Surgeries
- Keywords
- External Oblique Intercostal Block, Subcostal Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 16 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.
The aim of the study is to compare the analgesic efficacy of external oblique intercostal block vs subcostal transversus abdominis plane block in patients undergoing open nephrectomy.
Detailed description
This randomized controlled double blinded study will be done on 80 patients (40 in each group), patients will be randomly classified by computer generated numbers. Through a sealed opaque envelope technique, a blinded nurse who will not participate in the study or data collection, will read the number contained in the envelope and make group assignments.
All patients will be seen in the anesthesia clinic, optimization of general condition and all required investigations will be done before surgery. Patients will be premedicated with 1.5 mg midazolam and 4 mg granisetron. Basic monitoring will be applied to the patients such as Pulse oximetry (SPO2), Non-invasive blood pressure (NIBP), Electrocardiogram (ECG), Capnogram and temperature probe.
After adequate preoxygenation, induction of general anesthesia will be done through wide bore cannula using 1 mic/kg fentanyl, 1-2 mg/kg titration of propofol, 0.5mg/kg atracurium. Patients were mechanically ventilated using volume-controlled ventilation (VCV) with adjustment of end tidal carbon dioxide (ETCO2) to be 32-35 mmHg, 50% inspired oxygen in air and sevoflurane concentration to be 1MAC. The patients will receive either block before skin incision that will be done 20 minutes after the block. 0.5 mic/kg fentanyl will be injected when heart rate or blood pressure increases more than 20% of baseline. By the end of the surgery, 1gm paracetamol will be administered with fully reversal of muscle relaxants at the end of the surgery.
Group E This group of patients will receive external oblique intercostal block in supine position. A high-frequency linear transducer will be placed in sagittal plane between the midclavicular and anterior axillary line at the level of the 6 to 8th rib. The pointing mark of the probe will be directed cranially and may be slightly tilted medially for better identification of external oblique muscle and intercostal muscles.
After sterilization of skin and through the in-plane technique directing from cranial to caudal, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.
Group T Subcostal transversus abdominis plane block will be applied to this group and patients will be supine. A high-frequency linear transducer will be placed directly below and along costal margin. After sterilization of skin, with in-plane technique and from lateral to medial, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.
After extubation, the patients will be transferred to PACU (Post-Anesthesia Care Unit) for monitoring. Numerical rating scale (NRS) will be used for pain assessment while 0 is no pain and 10 is severe agonizing pain. Patients will be given a rescue analgesia of 0.05 mg / kg morphine if NRS ≥ 4 and repeated if needed after 20 minutes. 1 gm paracetamol every 8 h and 30 mg ketorolac (if not contraindicated) every 12 h will be given regularly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group E | Active comparator | Procedure: External Oblique Intercostal BlockThis group of patients will receive external oblique intercostal block in supine position. A high-frequency linear transducer will be placed in sagittal plane between the midclavicular and anterior axillary line at the level of the 6 to 8th rib. The pointing mark of the probe will be directed cranially and may be slightly tilted medially for better identification of external oblique muscle and intercostal muscles. After sterilization of skin and through the in-plane technique directing from cranial to caudal, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it. |
| group T | Active comparator | Procedure: Subcostal Transversus Abdominis Plane BlockSubcostal transversus abdominis plane block will be applied to this group and patients will be supine. A high-frequency linear transducer will be placed directly below and along costal margin. After sterilization of skin, with in-plane technique and from lateral to medial, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who will be included in the study age from 21 to 60 years, both male and female, with American Society of Anesthesiologists (ASA) Physical Status Classification System I-III.
Key exclusion criteria (1 listed)
- Any patient refuses to participate, has bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases, on chronic opioid use, with history of allergy to local anesthetics and has infection at the needle entry point will be excluded.
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 |
|---|---|---|
| External Oblique Intercostal BlockIn group E, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it. | Procedure or surgery | group E |
| Subcostal Transversus Abdominis Plane BlockIn group T, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle. | Procedure or surgery | group T |
Primary outcome
Total morphine consumption in the first postoperative 24 hour
Time frame: first postoperative 24 hour
Total morphine consumption in the first postoperative 24 hour
2 secondary outcomes
NRS when patient reach recovery room and at 2 hour, 6 hour, 12 hour, 18 hour and 24 hour
Time frame: when patient reach recovery room and at 2 hour, 6 hour, 12 hour, 18 hour and 24 hour
Total intraoperative fentanyl consumption with exclusion of fentanyl used in induction
Time frame: intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background1.Bansal P, Sultania N, Mittal T. External oblique intercostal block in open nephrectomy patients-A zenith in analgesia for anterolateral upper abdominal surgeries: A case series. Asian Journal of Medical Sciences. 2024;15(2):264-8.
- https://ajmsjournal.info/index.php/AJMS/article/view/382?articlesBySimilarityPage=15Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. sharing abstract and final paper on a medical journal
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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.
Ahmed A Abdelwahed, lecturer principal investigator
Tanta 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 External Oblique Intercostal Block and Subcostal Transversus Abdominis Plane Block in people with Analgesia , Open Renal Surgeries, run by Tanta 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
Total morphine consumption in the first postoperative 24 hour (time frame: first postoperative 24 hour). 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 NCT06778707, which also lists 1 linked publication.
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 16 Jan 2025.