Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block

Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block for Controlling Postoperative Pain After Umbilical Hernia Repair

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: erector spinae plane (ESP) block; Procedure: oblique subcostal transverse abdominis plane (TAP) block

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

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: michael A shaker, lecturer; Phone Number: 002 01096457282; Email: michaeladelshaker@gamil.com
• Study Contact Backup: Name: salwa s ElSherbeny, lecturer; Phone Number: 002 01128595629

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44511
      • Recruiting
      • Zagazig university hospital
      • Contact: Hala A ALsadek, professor; Phone Number: 002 01224897773

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative analgesic requirements	measuring the total doses of analgesic required to relieve the pain	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain severity using Visual Analogue scale	assessing pain severity using Visual Analogue scale (VAS) (0-100mm)	24 hours postoperative
Postoperative pain severity using Verbal Rating Scale	assessing pain severity using Verbal Rating Scale (mild, moderate and severe)	24 hours postoperative
Postoperative pain severity using Numeric Rating Scale	assessing pain severity using Numeric Rating Scale (NRS) (0-10; 0, no pain; 10, worst pain)	24 hours postoperative
Postoperative heart rate changes	monitoring postoperative changes in the heart rate (HR) measured by beat per minute (BPM) and comparing it with the preoperative measures	24 hours postoperative
Postoperative blood pressure changes	monitoring postoperative changes in the blood pressure (BP) measured by mm Hg and comparing it with the preoperative measures.	24 hours postoperative
Incidence of postoperative side effects	recording any postoperative complications as nausea and vomiting	24 hours postoperative
Duration of postoperative hospital stay	measuring the delay in discharging the patients postoperative because of the pain	24 hours postoperative

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: MICHAEL A shaker, lecturer, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 8034-7-11-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No