Patient SatisfactionNCT07311525
Ultrasound-Guided RSCTL vs EOIP Block for Analgesia in Sleeve Gastrectomy
A study testing ultrasound-guided Retro superior costotransverse ligament space block and ultrasound-guided External Oblique Intercostal Plane Block in people with Patient Satisfaction, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effect of ultrasound-guided retro-SCTL space block and EOI block on opioid consumption within 24 hours after LSG. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- ultrasound-guided Retro superior costotransverse ligament space block and ultrasound-guided External Oblique Intercostal Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Feb 2027
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged between 18 to 65 years
- Both genders
- American Society of Anesthesiologists (ASA) physical status I-II
- Body mass index (BMI) > 40 kg m-2,
Who cannot join
- Obesity secondary to an endocrine disorder
- known allergic diathesis to any drugs used in the study
- Presence of serious systemic illness (e.g., severe cardiac, pulmonary, renal, or hepatic dysfunction),
- Coagulation dysfunction
- Pre-existing psychological disorders
- Current use of analgesic or psychotropic medications
Show all 9Show fewer
- Infection at a potential injection site
- Ahistory of chronic pain
- Conversion to laparotomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University hospital
Banī Suwayf, Beni Suweif Governorate, 62511
Dina M Fakhry, MD, 01289998680, drdina.mahmoud@med.bsu.edu.eg
About this study
Official title: Efficacy of Ultrasound-guided Retro Superior Costotransverse Ligament Space Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Study
The aim of this study is to compare the effect of ultrasound-guided retro-SCTL space block and EOI block on opioid consumption within 24 hours after LSG.
Read the detailed description
Obesity is ranked as the 5th cause of preventable death and is associated with certain diseases, e.g., type 2 diabetes mellitus, hypertension, ischemic heart disease, hyperlipidemia, and sleep apnea. Egypt has the world's 18th highest obesity prevalence, according to the World Health Organization (WHO). Bariatric surgery is the most effective treatment for weight loss, reducing obesity-related comorbidities and mortality. This surgery has been shown to improve quality of life. Bariatric surgery is now universally performed laparoscopically and is the most performed elective surgery in patients with morbid obesity. Laparoscopic sleeve gastrectomy (LSG) has been shown to be related to lower complication rates, shorter hospital stays, and earlier re-engagement in normal activities than open procedures. However, postoperative pain is common. Pain often originates from port sites in the abdominal wall. As LSG requires removal of the relatively large resected gastric segment, this often requires enlargement of the trocar site and the fascial incision, which adds to the pain. Postoperative pain may be significant and has a negative impact on recovery, respiration, hemodynamics, mentation, ambulation, bowel function, and length of hospital stay. Also, opioid analgesia in obese patients is associated with serious adverse effects such as hypopnoea, hypoxaemia, drowsiness, ileus, vomiting, delayed ambulation, and mortality. These complications are compounded by pre-existing obstructive sleep apnea (OSA), cardiorespiratory insufficiency, psychiatric disorders, and chronic opioid use, which may be present in obese patients. Although epidural anesthesia is effective in pain control, positioning is extremely difficult in obese patients. Some regional anesthesia techniques such as transverse abdominis plane (TAP) block, quadratus lumborum (QL) block, and erector spinae plane (ESP) block may be used as a part of a multimodal analgesic regimen to reduce opioid consumption
. However, technical challenges such as difficulty in identifying the structures and limitations in needle movement may be experienced due to the deep anatomical location of structures when performing these blocks in patients with obesity.
Intertransverse process block (ITPB) is a paraspinal thoracic nerve block technique where the local anesthetic (LA) is injected into the thoracic "intertransverse tissue complex", behind the superior costotransverse ligament (SCTL). The retro superior costotransverse ligament space (retro-SCTL space) block is a novel ITPB, targeting the fat-filled space in the retro-SCTL space. ITPB may be technically simpler and safer to avoid pleural puncture than a thoracic paravertebral block (TPVB) since it does not require direct needle access to the thoracic paravertebral space.
External oblique intercostal plane (EOI) block, a nerve block , has an efficacy range of T6-10. EOI block is one of the novel interfascial plane blocks. EOI block can be performed as part of multimodal analgesia for upper abdominal surgeries. In addition, easy visualization of the application area with ultrasound guidance is an advantage for obese patients. While both retro-SCTL and EOI blocks are emerging techniques, a direct comparison of their analgesic efficacy and opioid-sparing effects in the context of LSG has not yet been performed. This study aims to directly address this gap.
- Conditions
- Patient Satisfaction
- Being tested
- ultrasound-guided Retro superior costotransverse ligament space block, ultrasound-guided External Oblique Intercostal Plane Block
- Keywords
- Sleeve Gastrectomy, Postoperative Analgesia, External Oblique Intercostal Plane Block, Retro superior costotransverse ligament space block
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided Retro superior costotransverse ligament space blockProcedure or surgery
Participants will receive ultrasound-guided Retro superior costotransverse ligament space block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.
ultrasound-guided External Oblique Intercostal Plane BlockProcedure or surgery
Participants will receive ultrasound-guided External Oblique Intercostal Plane Block after intubation.Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.
| Study group | Role | What they receive |
|---|---|---|
| retro-SCTL block | Active comparator | Participants in the (group retro-SCTL) will receive ultrasound-guided retro-SCTL space block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side. Receives: Procedure: ultrasound-guided Retro superior costotransverse ligament space block |
| EOI block | Active comparator | Participants in the (group EOI) will receive ultrasound-guided EOI block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side. Receives: Procedure: ultrasound-guided External Oblique Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative morphine consumption within the first 24 hours.
cumulative morphine consumption within the first 24 hours.
Measured: 24 hours post operative
Secondary outcomes (2)
Visual analogue scale (VAS) score for pain
The VAS is a pain rating scale. Scores are based onself-reported measures of symptoms that are recorded witha single handwritten mark placed at one point along thelength of a 10-cm line that represents a continuum betweenthe two ends of the scale-"no pain" on the left end (0 cm) ofthe scale and the "worst pain" on the right end of the scale(10 cm).Visual analogue scale (VAS) score: will be assessed at rest and during movement at 30 min, 1, 3, 6, 12, 24 h postoperatively. A score ≤ 3 will be considered acceptable for pain relief. Supplementary rescue analgesia will be administered in the form of morphine IV 2 mg (at VAS ≥ 4), which may be repeated after 20 minutes.
Measured: 30 minutes, 1, 3, 6, 12, 24 hours postoperatively
A Sedation scale
A Sedation scale will be applied to determine the sedation scores (0 = awake, 1 = drowsy, 2 = asleep but arousable, and 3 = deeply asleep). A sedation score of > 0 indicates being sedated at any time throughout the initial postoperative 24 hours
Measured: Initial 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mahmoud Fakhry, Beni-Suef University
- Investigators
- Dina M Fakhry, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311525
- Sponsor's protocol ID
- FMBSUREC/05102025/Fakhry
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-guided Retro Superior Costotransverse Ligament Space Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07311525
- Acronym / sponsor ID
- FMBSUREC/05102025/Fakhry
- Conditions
- Patient Satisfaction
- Keywords
- Sleeve Gastrectomy, Postoperative Analgesia, External Oblique Intercostal Plane Block, Retro superior costotransverse ligament space block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 31 Dec 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 this study is to compare the effect of ultrasound-guided retro-SCTL space block and EOI block on opioid consumption within 24 hours after LSG.
Detailed description
Obesity is ranked as the 5th cause of preventable death and is associated with certain diseases, e.g., type 2 diabetes mellitus, hypertension, ischemic heart disease, hyperlipidemia, and sleep apnea. Egypt has the world's 18th highest obesity prevalence, according to the World Health Organization (WHO). Bariatric surgery is the most effective treatment for weight loss, reducing obesity-related comorbidities and mortality. This surgery has been shown to improve quality of life. Bariatric surgery is now universally performed laparoscopically and is the most performed elective surgery in patients with morbid obesity. Laparoscopic sleeve gastrectomy (LSG) has been shown to be related to lower complication rates, shorter hospital stays, and earlier re-engagement in normal activities than open procedures. However, postoperative pain is common. Pain often originates from port sites in the abdominal wall. As LSG requires removal of the relatively large resected gastric segment, this often requires enlargement of the trocar site and the fascial incision, which adds to the pain. Postoperative pain may be significant and has a negative impact on recovery, respiration, hemodynamics, mentation, ambulation, bowel function, and length of hospital stay. Also, opioid analgesia in obese patients is associated with serious adverse effects such as hypopnoea, hypoxaemia, drowsiness, ileus, vomiting, delayed ambulation, and mortality. These complications are compounded by pre-existing obstructive sleep apnea (OSA), cardiorespiratory insufficiency, psychiatric disorders, and chronic opioid use, which may be present in obese patients. Although epidural anesthesia is effective in pain control, positioning is extremely difficult in obese patients. Some regional anesthesia techniques such as transverse abdominis plane (TAP) block, quadratus lumborum (QL) block, and erector spinae plane (ESP) block may be used as a part of a multimodal analgesic regimen to reduce opioid consumption
. However, technical challenges such as difficulty in identifying the structures and limitations in needle movement may be experienced due to the deep anatomical location of structures when performing these blocks in patients with obesity.
Intertransverse process block (ITPB) is a paraspinal thoracic nerve block technique where the local anesthetic (LA) is injected into the thoracic "intertransverse tissue complex", behind the superior costotransverse ligament (SCTL). The retro superior costotransverse ligament space (retro-SCTL space) block is a novel ITPB, targeting the fat-filled space in the retro-SCTL space. ITPB may be technically simpler and safer to avoid pleural puncture than a thoracic paravertebral block (TPVB) since it does not require direct needle access to the thoracic paravertebral space.
External oblique intercostal plane (EOI) block, a nerve block , has an efficacy range of T6-10. EOI block is one of the novel interfascial plane blocks. EOI block can be performed as part of multimodal analgesia for upper abdominal surgeries. In addition, easy visualization of the application area with ultrasound guidance is an advantage for obese patients. While both retro-SCTL and EOI blocks are emerging techniques, a direct comparison of their analgesic efficacy and opioid-sparing effects in the context of LSG has not yet been performed. This study aims to directly address this gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retro-SCTL block | Active comparator | Procedure: ultrasound-guided Retro superior costotransverse ligament space blockParticipants in the (group retro-SCTL) will receive ultrasound-guided retro-SCTL space block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side. |
| EOI block | Active comparator | Procedure: ultrasound-guided External Oblique Intercostal Plane BlockParticipants in the (group EOI) will receive ultrasound-guided EOI block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 to 65 years
- Both genders
- American Society of Anesthesiologists (ASA) physical status I-II
- Body mass index (BMI) > 40 kg m-2,
Key exclusion criteria (9 listed)
- Obesity secondary to an endocrine disorder
- known allergic diathesis to any drugs used in the study
- Presence of serious systemic illness (e.g., severe cardiac, pulmonary, renal, or hepatic dysfunction),
- Coagulation dysfunction
- Pre-existing psychological 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 |
|---|---|---|
| ultrasound-guided Retro superior costotransverse ligament space blockParticipants will receive ultrasound-guided Retro superior costotransverse ligament space block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side. | Procedure or surgery | retro-SCTL block |
| ultrasound-guided External Oblique Intercostal Plane BlockParticipants will receive ultrasound-guided External Oblique Intercostal Plane Block after intubation.Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side. | Procedure or surgery | EOI block |
Primary outcome
cumulative morphine consumption within the first 24 hours.
Time frame: 24 hours post operative
cumulative morphine consumption within the first 24 hours.
2 secondary outcomes
Visual analogue scale (VAS) score for pain
Time frame: 30 minutes, 1, 3, 6, 12, 24 hours postoperatively
A Sedation scale
Time frame: Initial 24 hours postoperatively
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 6 Jan 2026.
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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.
Dina M Fakhry, MD principal investigator
Beni-Suef 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 ultrasound-guided Retro superior costotransverse ligament space block and ultrasound-guided External Oblique Intercostal Plane Block in people with Patient Satisfaction, run by Beni-Suef 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 9 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: looking for participants now, as of the sponsor's last update on 6 Jan 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?
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?
Contact Dina M Fakhry, MD (00201289998680, dina_fakhry_91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative morphine consumption within the first 24 hours. (time frame: 24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.