RISS Versus Lower Thoracic ESP Block for Analgesia After Laparoscopic Abdominal Surgery: A Randomized Trial
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?
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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:
I. 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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Emad LM Ahmed, Lecturer
- Telefoonnummer: +201006531896
- E-mail: emad.ahmmed@must.edu.eg
Studie Contact Back-up
- Naam: Mohamed M Ahmed, Resident
- Telefoonnummer: 0201147888382
- E-mail: Manmoh980@gmail.com
Studie Locaties
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypte, 15525
- Souad Kafafi University Hospital (SKUH), Faculty of Medicine, MUST
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group A (n=35): Ultrasound-guided RISS block.
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.
|
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.
|
|
Actieve vergelijker: Group B (n=35): Receiving ultrasound-guided lower thoracic ESP block
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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative analgesia
Tijdsspanne: 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
|
from 0 to 24 hours postoperative
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Total morphine consumption (mg) in 24 h.
Tijdsspanne: from 0 to 24 hours postoperative
|
Doses of morphine given intravenous postoperatively according to severity of pain (NRS > 6) during the first 24 hours postoperatively
|
from 0 to 24 hours postoperative
|
|
Intra-operative vital signs (HR)
Tijdsspanne: Before induction of anesthesia till the end of surgery
|
Measuring the patient's heart rate (HR) before induction of anesthesia and every 15 minutes during surgery.
|
Before induction of anesthesia till the end of surgery
|
|
• Intra-operative vital signs: Mean Blood Pressure (MBP)
Tijdsspanne: Before induction of anesthesia till the end of surgery
|
Measuring the patient's Mean Blood Pressure (MBP) before induction of anesthesia and every 15 minutes during surgery.
|
Before induction of anesthesia till the end of surgery
|
|
Possible complications
Tijdsspanne: Intra- and post-operatively for 24 hours.
|
pneumothorax, LAST, vascular puncture
|
Intra- and post-operatively for 24 hours.
|
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Manar M ElKholy, Profesor, Prof. of Anesth, Kasr Alainy hospital, Faculty of Medicine, Cairo University
- Studie directeur: Mohamed Abdelaziz Taha, Assist. Prof., Assist. Prof. of Anesth, Souad Kafafi University hospital, Faculty of Medicine, MUST
- Studie directeur: Ahmed SK Elkhodary, Lecturer, Lecturer of surgery at Souad Kafafi University hospital, Faculty of Medicine, MUST
Publicaties en nuttige links
Algemene publicaties
- 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.
- Wang 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.
- Elsharkawy 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.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2025/0124
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
Researchers:
Who: Academic researchers, industry scientists, and regulatory agencies. What: Full IPD, including demographic data, treatment assignments, and outcome measures.
How: Through data sharing platforms or repositories after submitting a research proposal and obtaining necessary approvals.
Regulatory Authorities:
Who: Agencies like the FDA or EMA. What: Full IPD and supporting documentation for oversight and review. How: Direct access during the review process of clinical trial applications.
Data Sharing Initiatives:
Who: Collaborating institutions and consortia. What: Aggregated or anonymized IPD for meta-analyses or systematic reviews. How: Via established partnerships and shared databases.
Public and Patient Advocacy Groups:
Who: Organizations seeking to promote transparency. What: Summary data and aggregated results, but not individual-level data. How: Through publicly available reports or dashboards.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .