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

NCT06621472 | Recruiting

• 1 other identifier: analgesia in hepatectomy
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Cancer Liver

Outcome Measures

Primary Outcomes (1)

• post-operative analgesic consumption for 24 hours among study groups.

  measuring total dose of narcotics required for the patient in study groups

  for 24 hours postoperative

Study Arms (3)

• Group R: Retrolaminar block (RLB)

EXPERIMENTAL

Patients will receive bilateral ultrasound guided retrolaminar block with injection of 20 ml bupivacaine 0.25% in each side.

Procedure: Retrolaminar block group

Group T. Subcostal transversus abdominis plane block (STAP)

EXPERIMENTAL

Patients will receive bilateral Ultrasound guided subcostal TAP with injection of 20 ml bupivacaine 0.25% in each side.

Other: subcostal TAP technique

Epidural

EXPERIMENTAL

By loss of resistant technique and catheter insertion at the level of thoracic vertebrae (7-10)

Other: thoracic Epidural

Interventions

Retrolaminar block group PROCEDURE

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 position by visualizing the spread. After negative aspiration, 20 mL of 0.25% isobaric bupivacaine. The procedure will be repeated on the opposite side.

• Group R: Retrolaminar block (RLB)

subcostal TAP technique OTHER

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 muscle and will be followed back medially to confirm its position beneath the rectus muscle. the needle will be introduced through the rectus muscle in a superomedial-to-inferolateral direction towards the transversus abdominis muscle using the in-plane method, and 20 mL of 0.25% isobaric bupivacaine will be injected

Group T. Subcostal transversus abdominis plane block (STAP)

thoracic Epidural OTHER

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/h if necessary, bolus dose of 5 mL was allowed every 30 minutes.

Epidural

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11835, Egypt

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Related Links

• Agarwal V, Divatia JV: Enhanced recovery after surgery in liver resection: current concepts and controversies. Korean J Anesthesiol. 2019, 72:119-29. 10.4097/kja.d.19.00010

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Tea

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• sayed M Abed

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sayed M abed, MD degree

CONTACT

1226806532; sydabed2020@outlook.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: assistant professor

Model Details: double blind

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting in march 2025
• Access Criteria: web

Locations

EG (1)