Pain After SurgeryNCT07593300
RISS Versus Lower Thoracic ESP Block for Analgesia After Laparoscopic Abdominal Surgery: A Randomized Trial
A study testing Group A (n=35): Ultrasound-guided RISS block (RISS): and Group B (n=35): Ultrasound-guided lower thoracic ESP block in people with Pain After Surgery, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate the analgesic efficacy of ultrasound-guided Romboid Intercostal and Subserratus (RISS) block versus lower thoracic Erector Spinae Plane (ESP) block after laparoscopic abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain After Surgery
- What is being tested?
- Group A (n=35): Ultrasound-guided RISS block (RISS): and Group B (n=35): Ultrasound-guided lower thoracic ESP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2026to 31 Dec 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients scheduled for laparoscopic abdominal surgery (e.g., cholecystectomy, colectomy, sleeve gastrectomy, hernia repair, appendectomy).
- Age from 18 - 60 years old.
- Both sexes.
- American Society of Anesthesiology (ASA) classification I, II. (i.e., ASA I: a normal healthy patient; ASA II: patients with mild controlled systemic disease.
Who cannot join
- Patients who refuse the research consent.
- Allergy to local anesthetic drugs.
- Cardiac arrhythmia.
- Bleeding tendency (including pre-existing blood disease and patients on full anticoagulant therapy).
- Morbid obese patients (BMI>35 kg/m2)
- Vascular compromise of lower extremity (e.g., Burger disease, Raynaud's disease).
- Connective tissue disease (e.g., Scleroderma).
- Suspected malignancy or intra-abdominal infection.
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
Souad Kafafi University Hospital (SKUH), Faculty of Medicine, MUST
Giza, Giza Governorate, 15525
About this study
Official title: Analgesic Efficacy of Ultrasound-Guided Rhomboid Intercostal and Subserratus (RISS) Block Versus Lower Thoracic Erector Spinae Plane Block (ESPB) After Abdominal Laparoscopic Surgery
The goal of this clinical trial is to investigate the analgesic efficacy of ultrasound-guided Romboid Intercostal and Subserratus (RISS) block versus lower thoracic Erector Spinae Plane (ESP) block after laparoscopic abdominal surgery. The main questions it aims to answer are:
Does ultrasound-guided Romboid Intercostal and Subserratus (RISS) block is effective as the lower thoracic Erector Spinae Plane (ESP) block for intra and postoperative analgesia after laparoscopic abdominal surgery for the first 24 hours? What complications do participants have when doing these interventions?
Read more
Researchers will compare the analgesic efficacy of ultrasound-guided Romboid Intercostal and Subserratus (RISS) block with the lower thoracic Erector Spinae Plane (ESP) block after laparoscopic abdominal surgery.
Participants will:
Start general anesthesia and be given either block according to the randomization chart.
The blood pressure and heart rate will be measured at intervals to determine if the participants need extra intraoperative analgesics.
Numerical Rating Scale (NRS) will be used postoperatively to test pain severity.
Rescue morphine analgesia will be measured and compared in both groups.
Any complications will be reported.
Patient and surgeon satisfaction will be measured.
Read the detailed description
The aim of this study is to investigate the analgesic efficacy of ultrasound-guided Romboid Intercostal and Subserratus (RISS) block versus lower thoracic Erector Spinae Plane (ESP) block after laparoscopic abdominal surgery.
Hypothesis
This study hypothesize that both RISS and ESP blocks relieve somatic pain equally, but ESP block relieves visceral pain better than RISS block, thereby reducing opioid consumption and improving patient satisfaction.
Methodology using:
- Study design
Double-blinded randomized clinical trial study.
II. Study setting and location The study will be conducted at the operative theater of Souad Kafafi University Hospital (SKUH), Misr University for Science and Technology (MUST).
III. Study population:
Patients aged from 18 to 60 years old scheduled for laparoscopic abdominal surgery will be randomized in a 1:1 ratio after induction of general anesthesia, either:
Group A: Receiving ultrasound-guided RISS block. A solution composed of 20 ml mixed xylocaine 1% + 0.25% bupivacaine + 4 mg dexamethasone on each side.
Group B: Receiving ultrasound-guided lower thoracic ESP block (T8-T9) A solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side.
The infiltrative local anesthesia will be administered via a 22-gauge, 80-mm Echogenic block needle.
Postoperative analgesia:
The participants in both groups will receive analgesia in accordance with the following protocol:
- Pain will be assessed using a Numerical Rating Scale (NRS) 0-10.
- Mild pain (NRS 1-3) will be treated with 1 g paracetamol IV every six hours (maximum 4 g/day).
- Moderate pain (NRS 4-6) will receive the same paracetamol regimen plus ketorolac 30 mg IV every eight hours (maximum 120 mg/day).
- Severe pain (NRS 7-10) will receive the above plus 0.1 mg/kg IV morphine when indicated. Study outcomes: Primary Outcome Measure:
- Efficacy of postoperative analgesia for first 24 hours.
Secondary Outcome Measures:
- Total morphine equivalent consumption (mg) in 24 h.
- Surgeon satisfaction (ability to perform active movements, 1-5 scale).
- Patient satisfaction (1-5 scale).
- Onset time of analgesia (min).
- Duration of postoperative analgesia (time to first rescue).
- Pain intensity via NRS at 2, 6, 12, 18, and 24 h.
- Intraoperative vital signs (HR, NIBP).
- Possible complications (pneumothorax, LAST, and vascular puncture) intra- and post-operatively.
Sample size calculation The sample size calculation was performed using G. power 3.1.9.2 (Universität Kiel, Germany). The sample size was calculated according to the total morphine dose in 24hr (4.21 in RISS vs. 4.65 in ESP) according to previous studies (9, 10). Based on the following considerations: 0.05 α error and 80% power of the study. Four cases were added to overcome dropout. Therefore, 70 patients will be allocated.
Statistical Analysis Statistical analysis will be done by SPSS v26 (IBM Inc., Chicago, IL, USA). Shapiro-Wilks test and histograms will be used to evaluate the normality of the distribution of data. Quantitative parametric variables will be presented as mean and standard deviation (SD) and compared between the two groups utilizing unpaired Student's t- test. Quantitative non-parametric data will be presented as median and interquartile range (IQR) and will be analyzed by Mann Whitney-test. Qualitative variables will be presented as frequency and percentage (%) and will be analyzed utilizing the Chi-square test or Fisher's exact test when appropriate. A two tailed P value < 0.05 will be considered statistically significant.
- Conditions
- Pain After Surgery
- Being tested
- Group A (n=35): Ultrasound-guided RISS block (RISS):, Group B (n=35): Ultrasound-guided lower thoracic ESP block
- Keywords
- Erector Spine Plane Block, Laparoscopic surgery, Rhomboid Intercostal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (n=35): Ultrasound-guided RISS block (RISS):Procedure or surgery
The patient will be positioned in the lateral decubitus with the ipsilateral arm abducted to move the scapula laterally and open the intercostal and subscapular spaces. A high-frequency linear probe (10-14 MHz) will be applied 1-2 cm medial to the medial scapular border in an oblique-sagittal plane at the T5-T6 level. Using an in-plane approach, a 22 G, 80 mm block needle will be advanced from superomedial to inferolateral (cephalocaudal) until the tip lies between RM and ICM. After negative aspiration and hydrodissection with 1-2 ml saline, 10 ml of the prepared solution (1% lidocaine + 0.25% bupivacaine + 4 mg dexamethasone) will be injected in 5 ml aliquots, with real-time observation of spread deep to RM. The probe will then be slid caudally and laterally to the T8-T9 level to visualize the fascial plane at the mid-axillary line between the serratus anterior (SA) muscle and the external intercostal muscle to inject the other 10 ml of local anesthetic.
Group B (n=35): Ultrasound-guided lower thoracic ESP blockProcedure or surgery
The patient will be positioned laterally. A linear probe will be placed 3 cm lateral to the posterior midline at the T8-T9 level to identify the transverse process (TP) and erector spinae muscle (ESM). A 22 G, 80 mm Echogenic block needle will be advanced in-plane from cranial to caudal until the tip rests deep to ESM but superficial to the TP. After negative aspiration, 20 ml of the prepared solution (1% lidocaine + 0.25% bupivacaine + 4 mg dexamethasone) will be injected in 5 ml aliquots, with real-time ultrasound confirmation of longitudinal spread cranially and caudally along the fascial plane. The block will be performed bilaterally following the same stepsA solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side.
| Study group | Role | What they receive |
|---|---|---|
| Group A (n=35): Ultrasound-guided RISS block. | Experimental | The patient will be positioned in the lateral decubitus with the ipsilateral arm abducted to move the scapula laterally and open the intercostal and subscapular spaces. A high-frequency linear probe (10-14 MHz) will be applied 1-2 cm medial to the medial scapular border in an oblique-sagittal plane at the T5-T6 level. Using an in-plane approach, a 22 G, 80 mm block needle will be advanced from superomedial to inferolateral (cephalocaudal) until the tip lies between RM and ICM. After negative aspiration and hydrodissection with 1-2 ml saline, 10 ml of the prepared solution (1% lidocaine + 0.25% bupivacaine + 4 mg dexamethasone) will be injected in 5 ml aliquots, with real-time observation of spread deep to RM. The probe will then be slid caudally and laterally to the T8-T9 level to visualize the fascial plane at the mid-axillary line between the serratus anterior (SA) muscle and the external intercostal muscle to inject the other 10 ml of local anesthetic. Receives: Procedure: Group A (n=35): Ultrasound-guided RISS block (RISS): |
| Group B (n=35): Receiving ultrasound-guided lower thoracic ESP block | Active comparator | The patient will be positioned laterally. A linear probe will be placed 3 cm lateral to the posterior midline at the T8-T9 level to identify the transverse process (TP) and erector spinae muscle (ESM). A 22 G, 80 mm Echogenic block needle will be advanced in-plane from cranial to caudal until the tip rests deep to ESM but superficial to the TP. After negative aspiration, 20 ml of the prepared solution (1% lidocaine + 0.25% bupivacaine + 4 mg dexamethasone) will be injected in 5 ml aliquots, with real-time ultrasound confirmation of longitudinal spread cranially and caudally along the fascial plane. The block will be performed bilaterally following the same stepsA solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side. Receives: Procedure: Group B (n=35): Ultrasound-guided lower thoracic ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
Pain will be assessed using a Numerical Rating Scale (NRS) (0-10 scale).
Will be measured by NRS at 0, 6, 12, 18, and 24 hours postoperative
- Mild pain (NRS 1-3) will be treated with 1 g paracetamol IV every six hours (maximum 4 g/day).
- Moderate pain (NRS 4-6) will receive the same paracetamol regimen plus ketorolac 30 mg IV every eight hours (maximum 120 mg/day).
- Severe pain (NRS 7-10) will receive the above plus 0.1 mg/kg IV morphine when indicated.
Measured: from 0 to 24 hours postoperative
Secondary outcomes (4)
Total morphine consumption (mg) in 24 h.
Doses of morphine given intravenous postoperatively according to severity of pain (NRS > 6) during the first 24 hours postoperatively
Measured: from 0 to 24 hours postoperative
Intra-operative vital signs (HR)
Measuring the patient's heart rate (HR) before induction of anesthesia and every 15 minutes during surgery.
Measured: Before induction of anesthesia till the end of surgery
• Intra-operative vital signs: Mean Blood Pressure (MBP)
Measuring the patient's Mean Blood Pressure (MBP) before induction of anesthesia and every 15 minutes during surgery.
Measured: Before induction of anesthesia till the end of surgery
Possible complications
pneumothorax, LAST, vascular puncture
Measured: Intra- and post-operatively for 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start20 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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 Pain After SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: Receiving ultrasound-guided RISS block. A solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side. Group B: Receiving ultrasound-guided lower thoracic ESP block (T8-T9) A solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side. The infiltrative local anesthesia will be administered via a 22-gauge, 80-mm Echogenic block needle
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Lotfy Mohammed Ahmed, Misr University for Science and Technology
- Investigators
- Manar M ElKholy, Profesor, Study chair, Prof. of Anesth, Kasr Alainy hospital, Faculty of Medicine, Cairo UniversityMohamed Abdelaziz Taha, Assist. Prof., Study director, Assist. Prof. of Anesth, Souad Kafafi University hospital, Faculty of Medicine, MUSTAhmed SK Elkhodary, Lecturer, Study director, Lecturer of surgery at Souad Kafafi University hospital, Faculty of Medicine, MUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593300
- Sponsor's protocol ID
- 2025/0124
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic Information: Age, sex, race, and other relevant demographic details. Baseline Characteristics: Health status, medical history, and any pre-existing conditions prior to the trial. Treatment Assignment: Information on the intervention or treatment each participant received. Outcome Measures: Data on primary and secondary outcomes as defined in the trial protocol. Adverse Events: Reports of any side effects or adverse events experienced by participants during the trial. Follow-up Data: Information collected during follow-up periods, including long-term outcomes
Publications
Lin J, Wu H, Wen Z, Li Y, Jiang C, Lin B, Gu Y. Subserratus Anterior Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Laparoscopic Radical Nephrectomy: Protocol for a Randomized Controlled, Double-Blind, Non-Inferiority Clinical Trial. J Pain Res. 2025 Mar 25;18:1615-1625. doi: 10.2147/JPR.S506226. eCollection 2025.
PubMed 40161212Wang S, Wang H, Chen X, Li M, Xu D. Ultrasound-Guided Continuous Rhomboid Intercostal and Sub-Serratus Plane Block Comparison of Thoracoscopic Intercostal Nerve Block After Thoracoscopic Surgery: A Prospective Randomized Controlled Study. J Pain Res. 2024 Dec 21;17:4471-4481. doi: 10.2147/JPR.S484092. eCollection 2024.
PubMed 39726901Elsharkawy H, Maniker R, Bolash R, Kalasbail P, Drake RL, Elkassabany N. Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation. Reg Anesth Pain Med. 2018 Oct;43(7):745-751. doi: 10.1097/AAP.0000000000000824.
PubMed 30169476
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound-Guided Rhomboid Intercostal and Subserratus (RISS) Block Versus Lower Thoracic Erector Spinae Plane Block (ESPB) After Abdominal Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07593300
- Acronym / sponsor ID
- 2025/0124
- Conditions
- Pain After Surgery
- Keywords
- Erector Spine Plane Block, Laparoscopic surgery, Rhomboid Intercostal block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 May 2026 (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 goal of this clinical trial is to investigate the analgesic efficacy of ultrasound-guided Romboid Intercostal and Subserratus (RISS) block versus lower thoracic Erector Spinae Plane (ESP) block after laparoscopic abdominal surgery. The main questions it aims to answer are:
Does ultrasound-guided Romboid Intercostal and Subserratus (RISS) block is effective as the lower thoracic Erector Spinae Plane (ESP) block for intra and postoperative analgesia after laparoscopic abdominal surgery for the first 24 hours? What complications do participants have when doing these interventions?
Researchers will compare the analgesic efficacy of ultrasound-guided Romboid Intercostal and Subserratus (RISS) block with the lower thoracic Erector Spinae Plane (ESP) block after laparoscopic abdominal surgery.
Participants will:
Start general anesthesia and be given either block according to the randomization chart.
The blood pressure and heart rate will be measured at intervals to determine if the participants need extra intraoperative analgesics.
Numerical Rating Scale (NRS) will be used postoperatively to test pain severity.
Rescue morphine analgesia will be measured and compared in both groups.
Any complications will be reported.
Patient and surgeon satisfaction will be measured.
Detailed description
The aim of this study is to investigate the analgesic efficacy of ultrasound-guided Romboid Intercostal and Subserratus (RISS) block versus lower thoracic Erector Spinae Plane (ESP) block after laparoscopic abdominal surgery.
Hypothesis
This study hypothesize that both RISS and ESP blocks relieve somatic pain equally, but ESP block relieves visceral pain better than RISS block, thereby reducing opioid consumption and improving patient satisfaction.
Methodology using:
- Study design
Double-blinded randomized clinical trial study.
II. Study setting and location The study will be conducted at the operative theater of Souad Kafafi University Hospital (SKUH), Misr University for Science and Technology (MUST).
III. Study population:
Patients aged from 18 to 60 years old scheduled for laparoscopic abdominal surgery will be randomized in a 1:1 ratio after induction of general anesthesia, either:
Group A: Receiving ultrasound-guided RISS block. A solution composed of 20 ml mixed xylocaine 1% + 0.25% bupivacaine + 4 mg dexamethasone on each side.
Group B: Receiving ultrasound-guided lower thoracic ESP block (T8-T9) A solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side.
The infiltrative local anesthesia will be administered via a 22-gauge, 80-mm Echogenic block needle.
Postoperative analgesia:
The participants in both groups will receive analgesia in accordance with the following protocol:
- Pain will be assessed using a Numerical Rating Scale (NRS) 0-10.
- Mild pain (NRS 1-3) will be treated with 1 g paracetamol IV every six hours (maximum 4 g/day).
- Moderate pain (NRS 4-6) will receive the same paracetamol regimen plus ketorolac 30 mg IV every eight hours (maximum 120 mg/day).
- Severe pain (NRS 7-10) will receive the above plus 0.1 mg/kg IV morphine when indicated. Study outcomes: Primary Outcome Measure:
- Efficacy of postoperative analgesia for first 24 hours.
Secondary Outcome Measures:
- Total morphine equivalent consumption (mg) in 24 h.
- Surgeon satisfaction (ability to perform active movements, 1-5 scale).
- Patient satisfaction (1-5 scale).
- Onset time of analgesia (min).
- Duration of postoperative analgesia (time to first rescue).
- Pain intensity via NRS at 2, 6, 12, 18, and 24 h.
- Intraoperative vital signs (HR, NIBP).
- Possible complications (pneumothorax, LAST, and vascular puncture) intra- and post-operatively.
Sample size calculation The sample size calculation was performed using G. power 3.1.9.2 (Universität Kiel, Germany). The sample size was calculated according to the total morphine dose in 24hr (4.21 in RISS vs. 4.65 in ESP) according to previous studies (9, 10). Based on the following considerations: 0.05 α error and 80% power of the study. Four cases were added to overcome dropout. Therefore, 70 patients will be allocated.
Statistical Analysis Statistical analysis will be done by SPSS v26 (IBM Inc., Chicago, IL, USA). Shapiro-Wilks test and histograms will be used to evaluate the normality of the distribution of data. Quantitative parametric variables will be presented as mean and standard deviation (SD) and compared between the two groups utilizing unpaired Student's t- test. Quantitative non-parametric data will be presented as median and interquartile range (IQR) and will be analyzed by Mann Whitney-test. Qualitative variables will be presented as frequency and percentage (%) and will be analyzed utilizing the Chi-square test or Fisher's exact test when appropriate. A two tailed P value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A: Receiving ultrasound-guided RISS block. A solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side. Group B: Receiving ultrasound-guided lower thoracic ESP block (T8-T9) A solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side. The infiltrative local anesthesia will be administered via a 22-gauge, 80-mm Echogenic block needle
| Arm | Type | Receives |
|---|---|---|
| Group A (n=35): Ultrasound-guided RISS block. | Experimental | Procedure: Group A (n=35): Ultrasound-guided RISS block (RISS):The patient will be positioned in the lateral decubitus with the ipsilateral arm abducted to move the scapula laterally and open the intercostal and subscapular spaces. A high-frequency linear probe (10-14 MHz) will be applied 1-2 cm medial to the medial scapular border in an oblique-sagittal plane at the T5-T6 level. Using an in-plane approach, a 22 G, 80 mm block needle will be advanced from superomedial to inferolateral (cephalocaudal) until the tip lies between RM and ICM. After negative aspiration and hydrodissection with 1-2 ml saline, 10 ml of the prepared solution (1% lidocaine + 0.25% bupivacaine + 4 mg dexamethasone) will be injected in 5 ml aliquots, with real-time observation of spread deep to RM. The probe will then be slid caudally and laterally to the T8-T9 level to visualize the fascial plane at the mid-axillary line between the serratus anterior (SA) muscle and the external intercostal muscle to inject the other 10 ml of local anesthetic. |
| Group B (n=35): Receiving ultrasound-guided lower thoracic ESP block | Active comparator | Procedure: Group B (n=35): Ultrasound-guided lower thoracic ESP blockThe patient will be positioned laterally. A linear probe will be placed 3 cm lateral to the posterior midline at the T8-T9 level to identify the transverse process (TP) and erector spinae muscle (ESM). A 22 G, 80 mm Echogenic block needle will be advanced in-plane from cranial to caudal until the tip rests deep to ESM but superficial to the TP. After negative aspiration, 20 ml of the prepared solution (1% lidocaine + 0.25% bupivacaine + 4 mg dexamethasone) will be injected in 5 ml aliquots, with real-time ultrasound confirmation of longitudinal spread cranially and caudally along the fascial plane. The block will be performed bilaterally following the same stepsA solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients scheduled for laparoscopic abdominal surgery (e.g., cholecystectomy, colectomy, sleeve gastrectomy, hernia repair, appendectomy).
- Age from 18 - 60 years old.
- Both sexes.
- American Society of Anesthesiology (ASA) classification I, II. (i.e., ASA I: a normal healthy patient; ASA II: patients with mild controlled systemic disease.
Key exclusion criteria (8 listed)
- Patients who refuse the research consent.
- Allergy to local anesthetic drugs.
- Cardiac arrhythmia.
- Bleeding tendency (including pre-existing blood disease and patients on full anticoagulant therapy).
- Morbid obese patients (BMI>35 kg/m2)
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 |
|---|---|---|
| Group A (n=35): Ultrasound-guided RISS block (RISS):The patient will be positioned in the lateral decubitus with the ipsilateral arm abducted to move the scapula laterally and open the intercostal and subscapular spaces. A high-frequency linear probe (10-14 MHz) will be applied 1-2 cm medial to the medial scapular border in an oblique-sagittal plane at the T5-T6 level. Using an in-plane approach, a 22 G, 80 mm block needle will be advanced from superomedial to inferolateral (cephalocaudal) until the tip lies between RM and ICM. After negative aspiration and hydrodissection with 1-2 ml saline, 10 ml of the prepared solution (1% lidocaine + 0.25% bupivacaine + 4 mg dexamethasone) will be injected in 5 ml aliquots, with real-time observation of spread deep to RM. The probe will then be slid caudally and laterally to the T8-T9 level to visualize the fascial plane at the mid-axillary line between the serratus anterior (SA) muscle and the external intercostal muscle to inject the other 10 ml of local anesthetic. | Procedure or surgery | Group A (n=35): Ultrasound-guided RISS block. |
| Group B (n=35): Ultrasound-guided lower thoracic ESP blockThe patient will be positioned laterally. A linear probe will be placed 3 cm lateral to the posterior midline at the T8-T9 level to identify the transverse process (TP) and erector spinae muscle (ESM). A 22 G, 80 mm Echogenic block needle will be advanced in-plane from cranial to caudal until the tip rests deep to ESM but superficial to the TP. After negative aspiration, 20 ml of the prepared solution (1% lidocaine + 0.25% bupivacaine + 4 mg dexamethasone) will be injected in 5 ml aliquots, with real-time ultrasound confirmation of longitudinal spread cranially and caudally along the fascial plane. The block will be performed bilaterally following the same stepsA solution composed of 20 ml mixed xylocaine 1% + 0.25 % bupivacaine + 4 mg dexamethasone on each side. | Procedure or surgery | Group B (n=35): Receiving ultrasound-guided lower thoracic ESP block |
Primary outcome
Postoperative analgesia
Time frame: from 0 to 24 hours postoperative
Pain will be assessed using a Numerical Rating Scale (NRS) (0-10 scale). Will be measured by NRS at 0, 6, 12, 18, and 24 hours postoperative 1. Mild pain (NRS 1-3) will be treated with 1 g paracetamol IV every six hours (maximum 4 g/day). 2. Moderate pain (NRS 4-6) will receive the same paracetamol regimen plus ketorolac 30 mg IV every eight hours (maximum 120 mg/day). 3. Severe pain (NRS 7-10) will receive the above plus 0.1 mg/kg IV morphine when indicated.
4 secondary outcomes
Total morphine consumption (mg) in 24 h.
Time frame: from 0 to 24 hours postoperative
Intra-operative vital signs (HR)
Time frame: Before induction of anesthesia till the end of surgery
• Intra-operative vital signs: Mean Blood Pressure (MBP)
Time frame: Before induction of anesthesia till the end of surgery
Possible complications
Time frame: Intra- and post-operatively for 24 hours.
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 18 May 2026.
- Results publication: PubMed 40161212Lin J, Wu H, Wen Z, Li Y, Jiang C, Lin B, Gu Y. Subserratus Anterior Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Laparoscopic Radical Nephrectomy: Protocol for a Randomized Controlled, Double-Blind, Non-Inferiority Clinical Trial. J Pain Res. 2025 Mar 25;18:1615-1625. doi: 10.2147/JPR.S506226. eCollection 2025.
- Results publication: PubMed 39726901Wang S, Wang H, Chen X, Li M, Xu D. Ultrasound-Guided Continuous Rhomboid Intercostal and Sub-Serratus Plane Block Comparison of Thoracoscopic Intercostal Nerve Block After Thoracoscopic Surgery: A Prospective Randomized Controlled Study. J Pain Res. 2024 Dec 21;17:4471-4481. doi: 10.2147/JPR.S484092. eCollection 2024.
- Results publication: PubMed 30169476Elsharkawy H, Maniker R, Bolash R, Kalasbail P, Drake RL, Elkassabany N. Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation. Reg Anesth Pain Med. 2018 Oct;43(7):745-751. doi: 10.1097/AAP.0000000000000824.
- Individual participant dataSharing planned: Yes. Demographic Information: Age, sex, race, and other relevant demographic details. Baseline Characteristics: Health status, medical history, and any pre-existing conditions prior to the trial. Treatment Assignment: Information on the intervention or treatment each participant received. Outcome Measures: Data on primary and secondary outcomes as defined in the trial protocol. Adverse Events: Reports of any side effects or adverse events experienced by participants during the trial. Follow-up Data: Information collected during follow-up periods, including long-term outcomes
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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.
Manar M ElKholy, Profesor study chair
Prof. of Anesth, Kasr Alainy hospital, Faculty of Medicine, Cairo University
Mohamed Abdelaziz Taha, Assist. Prof. study director
Assist. Prof. of Anesth, Souad Kafafi University hospital, Faculty of Medicine, MUST
Ahmed SK Elkhodary, Lecturer study director
Lecturer of surgery at Souad Kafafi University hospital, Faculty of Medicine, MUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A (n=35): Ultrasound-guided RISS block (RISS): and Group B (n=35): Ultrasound-guided lower thoracic ESP block in people with Pain After Surgery, run by Misr University for Science and Technology 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 8 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: opening soon, as of the sponsor's last update on 18 May 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 Emad LM Ahmed, Lecturer (+201006531896, emad.ahmmed@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia (time frame: from 0 to 24 hours postoperative). 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 NCT07593300, 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 18 May 2026.