Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Open Liver Resection Surgery

NCT05253079 | Unknown

• 1 other identifier: MS-481-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Liver resection surgery is a common surgical procedure which is performed on patients with benign, malignant or metastatic hepatic tumor as well as for living liver donor. Liver resection surgery is usually performed through either right subcostal or inversed L-shaped incision; both approaches are associated with a significant postoperative pain which requires intensive analgesic plan to facilitate early mobilization and minimize complications. There are various lines for pain management in liver resection surgery such as systemic analgesic drugs, neuraxial blocks (e.g., thoracic epidural analgesia) and transversus abdominis plane \[TAP\] block). Systemic analgesic drugs are nearly constantly used in liver resection. However, being systemically administered, these drugs have many side effects on many organs and cannot totally eliminate postoperative pain. Thoracic epidural block is commonly associated with hypotension; furthermore, its use has other limitations such as delaying postoperative mobilization and possible hematoma and cord compression in patients with coagulopathy which is expected following liver resection. Therefore, there had been an increased interest in the use of abdominal field blocks to avoid disadvantages of neuraxial blocks and minimize the use of parenteral analgesic drugs. TAP block is one of the classic field blocks which is extensively used in laparotomies including liver resection. However, the lack of visceral pain control TAP block influences the quality of its analgesic effect in this type of patients. Nevertheless, TAP block, namely the subcostal approach, is still the recommended field block in the latest procedure-specific recommendations for pain management in liver resection as it is the only block which showed good evidence. In recent years, there has been increased interest in a newer field block, the erector spinae plane block (ESPB), due its easy performance and the possible coverage of visceral pain in addition to the somatic pain. ESPB showed promising results in liver resection surgery. ESBP was superior to TAP block in various abdominal surgeries. However, its analgesic efficacy had not been previously compared in relation to TAP in patients undergoing open liver resection surgery.

Conditions

Analgesia; Hepatic Resection Surgery

Outcome Measures

Primary Outcomes (1)

• total morphine requirement in the first 24 hours

  mg

  0.5 hour after extubation till 24 hour after extubation

Secondary Outcomes (7)

• intraoperative morphine requirement

  15 minutes after block administration till 1 minutes after extubation

• time to first morphine requirement

  1 minute after block administration till 24 hours postoperatively

• NRS

  0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room

• Time to independent movement

  0.5 hour after extubation till 24 hour after extubation

• heart rate

  15 minutes before induction of anesthesia, 15 minutes after induction of anesthesia, every 15 minutes intraoperatively and 0.5, 1, 2, 4, 6, 18, 24 hours postoperatively

Study Arms (2)

subcostal transversus abdominis plane block group

ACTIVE COMPARATOR

subcostal transversus abdominis plane block

Other: subcostal transversus plane block

erector spinae plane block group

ACTIVE COMPARATOR

erector spinae plane block

Other: erector spinae plane block

Interventions

subcostal transversus plane block OTHER

Patient in TAP block group will receive oblique subcostal TAP while in supine position using a linear 6-13 MHz ultrasound transducer. The operator will place the ultrasound probe obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The landmarks, which included the rectus abdominis muscle and underlying transversus abdominis muscle, will be identified near the costal margin and xyphoid. The probe will be then moved laterally until the aponeurosis of the external, internal oblique, and transversus abdominis are seen, and then the probe will be moved further laterally until the transversus abdominis muscle is identified. The operator will direct the needle toward the transversus abdominis, and the local anesthetic solution will be injected after negative aspiration between the rectus abdominis and transversus abdominis muscles along the subcostal line (in-plane superomedial to inferolateral)

subcostal transversus abdominis plane block group

erector spinae plane block OTHER

Patients in ESPB group will be turned to the lateral position and receive ESPB at the level of the 7th thoracic (T7) transverse process using a linear 6-13 MHz ultrasound transducer. The transducer will be positioned vertically 3 cm to the side of the midline to visualize the muscles of the back, the transverse process, and the pleura between the two transverse processes. Then, a 22G 10-mm needle will be introduced in the cranial-caudal direction toward the transverse process (T7) using the in-plane method till the needle tip crosses all the muscles. The tip of needle should be in the plane between the transverse process and the erector spinae muscle. After ensuring negative aspiration, the local anesthetic solution will be injected below the muscle. the procedure will be repeated on the other side

erector spinae plane block group

Eligibility Criteria

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

You may qualify if:

• adult patients (\>18 years),
• ASA-physical status I-III
• undergoing open liver resection surgery for either primary/metastatic hepatic malignancy, biliary tract malignancy, or benign hepatic tumor

You may not qualify if:

• history of allergy to any of the study drugs,
• a body mass index (BMI) \<18 or ≥ 35 kg/m2,
• coagulopathy (INR \>1.5 and/or platelet count \<70000/µL),
• local infection,
• history of chronic pain or regular opioid use;
• inability to comprehend the Numeric Rating Scale (NRS),
• liver resection combined with a second surgical procedure, laparoscopic resections,
• pregnant or lactating women.
• Patients with complicated procedures
• those needing postoperative ventilation will be excluded from the study

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

RECRUITING

Related Publications (1)

• Mostafa M, Mousa MS, Hasanin A, Arafa AS, Raafat H, Ragab AS. Erector spinae plane block versus subcostal transversus abdominis plane block in patients undergoing open liver resection surgery: A randomized controlled trial. Anaesth Crit Care Pain Med. 2023 Feb;42(1):101161. doi: 10.1016/j.accpm.2022.101161. Epub 2022 Sep 22.

  PMID: 36154912 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ahmed hasanin

CONTACT

01095076954; ahmedmohamedhasanin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 23, 2022
• Study Start: March 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)