RISS Versus Lower Thoracic ESP Block for Analgesia After Laparoscopic Abdominal Surgery: A Randomized Trial

NCT07593300 | Not Yet Recruiting DMC

• 1 other identifier: 2025/0124
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain After Surgery

Keywords

Erector Spine Plane Block; Laparoscopic surgery; Rhomboid Intercostal block

Outcome Measures

Primary Outcomes (1)

• 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 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.

  from 0 to 24 hours postoperative

Secondary Outcomes (4)

• Total morphine consumption (mg) in 24 h.

  from 0 to 24 hours postoperative

• Intra-operative vital signs (HR)

  Before induction of anesthesia till the end of surgery

• • Intra-operative vital signs: Mean Blood Pressure (MBP)

  Before induction of anesthesia till the end of surgery

• Possible complications

  Intra- and post-operatively for 24 hours.

Study Arms (2)

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.

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.

Procedure: Group B (n=35): Ultrasound-guided lower thoracic ESP block

Interventions

Group A (n=35): Ultrasound-guided RISS block (RISS): PROCEDURE

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 A (n=35): Ultrasound-guided RISS block.

Group B (n=35): Ultrasound-guided lower thoracic ESP block PROCEDURE

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.

Group B (n=35): Receiving ultrasound-guided lower thoracic ESP block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Souad Kafafi University Hospital (SKUH), Faculty of Medicine, MUST

Giza, Giza Governorate, 15525, Egypt

Location

Related Publications (3)

• 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.

  PMID: 40161212 RESULT

• 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.

  PMID: 39726901 RESULT

• 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.

  PMID: 30169476 RESULT

Study Officials

• Manar M ElKholy, Profesor

  Prof. of Anesth, Kasr Alainy hospital, Faculty of Medicine, Cairo University

  STUDY CHAIR

• Mohamed Abdelaziz Taha, Assist. Prof.

  Assist. Prof. of Anesth, Souad Kafafi University hospital, Faculty of Medicine, MUST

  STUDY DIRECTOR

• Ahmed SK Elkhodary, Lecturer

  Lecturer of surgery at Souad Kafafi University hospital, Faculty of Medicine, MUST

  STUDY DIRECTOR

Central Study Contacts

Emad LM Ahmed, Lecturer

CONTACT

+201006531896; emad.ahmmed@must.edu.eg

Mohamed M Ahmed, Resident

CONTACT

0201147888382; Manmoh980@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia, SICU and pain management, Faculty of medicine.

Model Details: 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

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 18, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: may 2026 to December 2026
• Access Criteria: 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.

Locations

EG (1)