## Protocol Section
### Identification Module
**NCT ID:** NCT05253079

**Brief Title:** Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Open Liver Resection Surgery

**Official Title:** Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Patients Undergoing Open Liver Resection Surgery: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** MS-481-2021
#### Organization
**Class:** OTHER
**Full Name:** Kasr El Aini Hospital
### Status Module
#### Completion Date
**Date:** 2022-05

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2022-03-11

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-10

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-03-01

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2022-02-23
**Type:** ACTUAL
**Study First Submit Date:** 2022-02-14
**Study First Submit QC Date:** 2022-02-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kasr El Aini Hospital

#### Responsible Party

**Investigator Affiliation:** Kasr El Aini Hospital

**Investigator Full Name:** Maha Mostafa Ahmad, MD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Analgesia

- Hepatic Resection Surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subcostal transversus abdominis plane block

**Intervention Names:**

- Other: subcostal transversus plane block

**Label:** subcostal transversus abdominis plane block group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** erector spinae plane block

**Intervention Names:**

- Other: erector spinae plane block

**Label:** erector spinae plane block group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- subcostal transversus abdominis plane block group

**Description:** 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)

**Name:** subcostal transversus plane block

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- erector spinae plane block group

**Description:** 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

**Name:** erector spinae plane block

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** mg

**Measure:** total morphine requirement in the first 24 hours

**Time Frame:** 0.5 hour after extubation till 24 hour after extubation

#### Secondary Outcomes

**Description:** mg

**Measure:** intraoperative morphine requirement

**Time Frame:** 15 minutes after block administration till 1 minutes after extubation

**Description:** hours

**Measure:** time to first morphine requirement

**Time Frame:** 1 minute after block administration till 24 hours postoperatively

**Description:** 11-points scale in which the patients are asked to circle the number between 0 and 10 that best describe their pain intensity. Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible

**Measure:** NRS

**Time Frame:** 0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room

**Description:** time in hours of being able to be independently mobile e.g. using the bathroom

**Measure:** Time to independent movement

**Time Frame:** 0.5 hour after extubation till 24 hour after extubation

**Description:** beat per minutes

**Measure:** heart rate

**Time Frame:** 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

**Description:** mmHg

**Measure:** mean arterial pressure

**Time Frame:** 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

**Description:** 1 = Awake and alert 2 = Slightly sedated, 3 = moderately sedated follows simple commands, 4 = deeply sedated, responds to nonpainful stimuli, 5 = deeply sedated, responds to painful stimuli, 6 = deeply sedated, unresponsive to painful stimuli

**Measure:** Modified Ramsay Sedation Score

**Time Frame:** 0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ahmedmohamedhasanin@gmail.com

**Name:** ahmed hasanin

**Phone:** 01095076954

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** Anesthesia.kasralainy@gmail.com

- **Name:** Anesthesia, Pain Management and Surgical ICU Department

- **Phone:** 00201222224057

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Kasr Alaini Hospital

**Status:** RECRUITING

**Zip:** 11562

### IPD Sharing Statement Module

**Description:** data can be available from the principle investigator upon reasonable request

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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 Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Hemat

- Name: Hematinics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
