Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286125
• Other study ID #: 8034-7-11-2021
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: July 2023
• Source: Zagazig University
• Contact: michael A shaker, lecturer
• Phone: 01096457282
• Email: michaeladelshaker[@]gamil.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Zagazig University hospital	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesic requirements	measuring the total doses of analgesic required to relieve the pain	24 hours postoperative
Secondary	Postoperative pain severity using Visual Analogue scale	assessing pain severity using Visual Analogue scale (VAS) (0-100mm)	24 hours postoperative
Secondary	Postoperative pain severity using Verbal Rating Scale	assessing pain severity using Verbal Rating Scale (mild, moderate and severe)	24 hours postoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of postoperative side effects	recording any postoperative complications as nausea and vomiting	24 hours postoperative
Secondary	Duration of postoperative hospital stay	measuring the delay in discharging the patients postoperative because of the pain	24 hours postoperative