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Recruiting NCT06621472

Retrolaminar Block Versus Subcostal Transversus Abdominis Plane Block in Liver Resection Surgery

No phase Interventional Cancer Liver

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Retrolaminar block group, subcostal TAP technique, thoracic Epidural.
Who it may be relevant to
Registry conditions: Cancer Liver. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Retrolaminar Block Versus Subcostal Transversus Abdominis Plane Block in Patients Undergoing Open Liver Resection Surgery

Overview

Adequate pain control improves postoperative outcomes and is imperative for enhanced recovery after surgery (ERAS) . Open liver resection surgery is associated with intraoperative blood loss, hypotension, coagulopathy, pulmonary complications, liver impairment, and renal impairment, making perioperative pain management challenging . Multimodal analgesic strategies employing regional techniques decrease postoperative pain and opioid consumption following liver resections. Thoracic epidural analgesia (TEA) is considered the 'gold standard' for open thoracic and abdominal surgical procedures .

Detailed description

The retrolaminar block (RLB) is a modified paravertebral block that administers local anesthetic between the lamina of the thoracic vertebra and the erector spinae muscles, using landmark technique or under ultrasound guidance, rather than entering the needle into the thoracic paravertebral space (TPVS) directly. Moreover, real-time ultrasound guidance can help identify the lamina and monitor the spread of local anesthetic .

Ultrasound-guided Subcostal Transversus Abdominis Plane (TAP) Block is proven to provide adequate analgesia for upper and lower abdominal surgeries. A local anesthetic (LA) is deposited in the plane between the transversus abdominis and posterior sheath of the rectus muscle in the subcostal region to anesthetize the anterior cutaneous branches of the lower intercostal nerves (T7-T11). In this study, we aimed to compare the analgesic effect of RLB and subcostal TAP block in patients undergoing open liver resection surgery.

Interventions

  • Procedure Retrolaminar block group
    patients will be placed in a sitting position. The transducer will be positioned vertically 3 cm lateral to the midline at the level of the 7th thoracic transverse process. The muscles of the back, the transverse process, and the pleura between two transverse processes will be visualized. The needle will be introduced in a cranial-caudal direction toward the lamina using the in-plane method until the tip lay in the lamina 1 mL of normal saline will be injected to confirm the correct needle tip p
  • Other subcostal TAP technique
    The transducer will be placed obliquely along the subcostal margin near the xiphisternum in the midline of the abdomen. The rectus abdominis muscle and underlying transversus abdominis muscle will be identified. The position of the transversus abdominis muscle will be confirmed by sliding the transducer laterally until the aponeuroses of the external and internal oblique muscle will be visualized. The transversus abdominis muscle will be then identified, being posterior to the internal oblique m
  • Other thoracic Epidural
    Before induction of general anesthesia the epidural catheter was inserted under sterile condition with a loss of resistance technique by an 18G needle at a mid-thoracic level (Th 7-10) to cover the dermatomes innervating the incision in the upper abdomen. The epidural infusion consisting of bupivacaine 1 mg/mL, and fentanyl 2 μg/mL was activated on the attending anesthesiologist's decision. Following the hospital protocols, the infusion rate was initiated at 5-10 mL/h, increased to maximum 15 mL

Primary outcome measures

  • post-operative analgesic consumption for 24 hours among study groups. [Time frame: for 24 hours postoperative]

Eligibility criteria

Inclusion criteria

Physical status American Society of Anesthesiologists (ASA)II, III. Body mass index (BMI): 20-35 kg/m2.

Exclusion criteria

Patient refusal Physical status ASA IV BMI \< 20 kg/m2 and \>35 kg/m2 known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).

History of psychological disorders and/or chronic pain. Contraindication to regional anesthesia e.g., local sepsis, pre- existing peripheral neuropathies, and coagulopathy.

Severe respiratory, cardiac disorders and renal disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Publications

  • Joshi GP, Kehlet H. Postoperative pain management in the era of ERAS: An overview. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):259-267. doi: 10.1016/j.bpa.2019.07.016. Epub 2019 Jul 25. PMID 31785712

Identifiers

NCT: NCT06621472 · analgesia in hepatectomy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗