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

NCT ID: NCT06621472

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-11-01

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 .

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.

Conditions

Cancer Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

• Group R: Retrolaminar block (RLB)

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

Group Type: EXPERIMENTAL

Retrolaminar block group

Intervention Type: 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 T. Subcostal transversus abdominis plane block (STAP)

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

Group Type: EXPERIMENTAL

subcostal TAP technique

Intervention Type: 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

Epidural

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

Group Type: EXPERIMENTAL

thoracic Epidural

Intervention Type: 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.

Interventions

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

Intervention Type: PROCEDURE

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 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

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sayed Mahmoud Abed

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sayed M Abed

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

sayed M abed, MD degree

Role: CONTACT

sydabed2020@outlook.com

1226806532 ext. +20

Facility Contacts

sayed M abed, MD degree

Role: primary

sydabed2020@outlook.com

01226806532 ext. +20

References

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.

Reference Type: BACKGROUND

PMID: 31785712 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/30841029/

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

Other Identifiers

analgesia in hepatectomy

Identifier Type: -

Identifier Source: org_study_id