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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMisr University for Science and Technology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/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 block

    Procedure/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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Group A (n=35): Ultrasound-guided RISS block.Experimental treatment 1 intervention
Group B: Group B (n=35): Receiving ultrasound-guided lower thoracic ESP blockActive comparator 1 intervention

Trial outcomes

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.

Time frame
from 0 to 24 hours postoperative

Secondary outcomes

1

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

Time frame
from 0 to 24 hours postoperative
2

Intra-operative vital signs (HR)

Measuring the patient's heart rate (HR) before induction of anesthesia and every 15 minutes during surgery.

Time frame
Before induction of anesthesia till the end of surgery
3

• 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.

Time frame
Before induction of anesthesia till the end of surgery
4

Possible complications

pneumothorax, LAST, vascular puncture

Time frame
Intra- and post-operatively for 24 hours.

Other outcomes

Sponsors and contacts

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