Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block

NCT ID: NCT05286125

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2023-12-15

Brief Summary

Comparing the impact of bilateral erector spinae plane block and transverse abdominis plane block on improving quality of pain management after umbilical hernia repair.

Detailed Description

Postoperative pain is an important problem after umbilical hernia repair which has negative effects on patient's hemodynamics and cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction.

Multiple analgesic strategies have been proposed including Non steroidal anti-inflammatory drugs (NSAIDs), opioids, epidural analgesia. Each of them has its limitations.

Ultra¬sound guided regional anesthesia techniques for abdominal wall can be effective components of multimodal postoperative analgesia with limited side-effects Erector spinae plane (ESP) block is a promising para-spinal bock that can achieve both visceral and somatic abdominal analgesia if the injection was performed at a lower thoracic level. Transverse abdominis plane (TAP) block which is considered a peripheral nerve block that is aimed at anesthetizing nerves supplying the anterior abdominal wall.

We will compare between erector spinae plane block and transverse abdominis plane block for controlling postoperative pain after umbilical hernia repair.

Patients will be allocated randomly into two equal groups by a computer-generated randomization table Group (E) (n=26): Patients will receive erector spinae plane (ESP) block after completion of surgery.

Group (T) (n= 26): Patients will receive oblique subcostal transverse abdominis plane (TAP) block after completion of surgery

Conditions

Postoperative Pain

Study Design

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

Study Groups

erector spinae plane (ESP) block group ( (E) group)

Under aseptic conditions, a high frequency linear transducer will be placed on the spinous process at T8 level on the parasagittal plane and then slid 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle.

Group Type: ACTIVE_COMPARATOR

erector spinae plane (ESP) block

Intervention Type: PROCEDURE

Using the in plane technique, the needle will be advanced between the transverse process and erector spinae muscle. The correct location will be confirmed using 1ml of Local Anesthetic (LA) to view hydrodissection(12). 19ml of LA will be injected between the muscle and transverse process.

oblique subcostal transverse abdominis plane (TAP) block ( (T) group) )

Under aseptic conditions, the probe will be initially placed below the xyphoid process to view the linea alba, then directed obliquely down the costal margin while keeping the rectus abdominis muscle in view. The transverse abdominis muscle come into view below the rectus abdominis muscle. The probe will be advanced further until the semilunaris is viewed.

Group Type: ACTIVE_COMPARATOR

oblique subcostal transverse abdominis plane (TAP) block

Intervention Type: PROCEDURE

An echogenic needle will be inserted in-plane until the needle tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles. Once the needle enters the TAP plane, a dynamic injection can be performed by advancing the needle under ultrasound guidance laterally in the pocket created by the initial injection of 5 - 10 mL of local anesthetic; as the needle is advanced, the remaining local anesthetic will be injected. This allows for a more lateral spread of the local anesthetic

Interventions

erector spinae plane (ESP) block

Using the in plane technique, the needle will be advanced between the transverse process and erector spinae muscle. The correct location will be confirmed using 1ml of Local Anesthetic (LA) to view hydrodissection(12). 19ml of LA will be injected between the muscle and transverse process.

Intervention Type: PROCEDURE

oblique subcostal transverse abdominis plane (TAP) block

An echogenic needle will be inserted in-plane until the needle tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles. Once the needle enters the TAP plane, a dynamic injection can be performed by advancing the needle under ultrasound guidance laterally in the pocket created by the initial injection of 5 - 10 mL of local anesthetic; as the needle is advanced, the remaining local anesthetic will be injected. This allows for a more lateral spread of the local anesthetic

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for elective umbilical hernia repair.
• Patient acceptance.
• Both sex
• Patient's age 21 - 60 years.
• Patients with American Society of Anesthesiologists (ASA) physical status I, II.
• BMI 25 - 30 kg m-2.

Exclusion Criteria

• Uncooperative patients and patients with psychological problems.
• Patients with liver or renal impairment.
• Patients with contraindication to regional anesthesia.
• Patients with history of allergy to drug used in the study.
• Patients with chronic pain.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michael Adel Shaker

lecturer of anaesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A shaker, lecturer

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Zagazig University hospital

Zagazig, Sharqia Province, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

michael A shaker, lecturer

Role: CONTACT

michaeladelshaker@gamil.com

01096457282 ext. 002

salwa s ElSherbeny, lecturer

Role: CONTACT

01128595629 ext. 002

Facility Contacts

Hala A ALsadek, professor

Role: primary

01224897773 ext. 002

Other Identifiers

8034-7-11-2021

Identifier Type: -

Identifier Source: org_study_id