Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Procedure: erector spinae plane (ESP) block; Procedure: oblique subcostal transverse abdominis plane (TAP) block

• Registration Number: NCT05286125
• Lead Sponsor: Zagazig University

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

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erector spinae plane (ESP) block group ( (E) group)	erector spinae plane (ESP) block	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.
oblique subcostal transverse abdominis plane (TAP) block ( (T) group) )	oblique subcostal transverse abdominis plane (TAP) block	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.

Primary Outcome Measures

Name	Time	Method
Postoperative analgesic requirements	24 hours postoperative	measuring the total doses of analgesic required to relieve the pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zagazig University hospital; 🇪🇬 Zagazig, Sharkia, Egypt