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

NCT ID: NCT05253079

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-05-31

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.

Detailed Description

An independent research assistant will be responsible for opening the envelope and drug preparation with no further involvement in the study. The local anesthetic solution preparation will be as follow; 2 syringes of 20 ml of 0.25% isobaric bupivacaine.

Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and pre-medication drugs will be delivered (metoclopramide 10 mg, and omeprazole 40 mg).

General anesthesia will be induced by 2-3 mg/kg propofol and 1-2 mcg/kg fentanyl. Tracheal intubation by direct laryngoscopy will be facilitated by atracurium 0.5 mg/kg. Anesthesia will be maintained by 2-2.5% sevoflurane and 0.1 mg/kg/20min atracurium.

After induction of anesthesia, patients will receive their assigned intervention.

Intraoperative analgesic management Morphine boluses (titrated 0.05 mg/kg boluses till response) will be given in case of inadequate analgesia (heart rate/mean blood pressure increase by 20% from the baseline) Intraoperative fluid and hemodynamic management will be according to the discretion of the attending anesthetist.

At the end of the surgery, all patients will receive intravenous paracetamol (1 g) and ketorolac (30 mg) before the extubation.

Postoperative care All patients will receive regular intravenous paracetamol 1 g/6hours and ketorolac 30 mg/8hours. Pain assessments using Numerical Rating Scale (NRS) will be performed at rest and during cough at 0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room. If NRS score is > 3 intravenous titration of 2 mg morphine is given slowly to be repeated after 30 minutes if pain persisted. If other opioids are given, morphine equivalent dose will be calculated using opioids conversion chart.

Intravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs.

the following data will be recorded Complications: hematoma, nausea, vomiting, itching, urine retention, constipation, Initial pathology, type and length of skin incision, duration of surgery, blood loss, need for blood transfusion, vasoactive drugs Age, sex, American society of anesthesiologist-physical status (ASA), comorbidity, weight, height and body mass index

Conditions

Analgesia; Hepatic Resection Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

subcostal transversus abdominis plane block group

subcostal transversus abdominis plane block

Group Type: ACTIVE_COMPARATOR

subcostal transversus plane block

Intervention Type: 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)

erector spinae plane block group

erector spinae plane block

Group Type: ACTIVE_COMPARATOR

erector spinae plane block

Intervention Type: 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

Interventions

subcostal transversus plane block

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)

Intervention Type: OTHER

erector spinae plane block

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maha Mostafa Ahmad, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alaini Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

ahmed hasanin

Role: CONTACT

ahmedmohamedhasanin@gmail.com

01095076954

Facility Contacts

Anesthesia, Pain Management and Surgical ICU Department

Role: primary

Anesthesia.kasralainy@gmail.com

00201222224057

References

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.

Reference Type: DERIVED

PMID: 36154912 (View on PubMed)

Other Identifiers

MS-481-2021

Identifier Type: -

Identifier Source: org_study_id