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.

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.

  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.

     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.

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.

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

may 2026 to December 2026

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.