Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Jan 2021
Longer than P75 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2021
CompletedFirst Submitted
Initial submission to the registry
December 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedJuly 12, 2023
July 1, 2023
2.8 years
December 22, 2021
July 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative analgesic requirements
measuring the total doses of analgesic required to relieve the pain
24 hours postoperative
Secondary Outcomes (7)
Postoperative pain severity using Visual Analogue scale
24 hours postoperative
Postoperative pain severity using Verbal Rating Scale
24 hours postoperative
Postoperative pain severity using Numeric Rating Scale
24 hours postoperative
Postoperative heart rate changes
24 hours postoperative
Postoperative blood pressure changes
24 hours postoperative
- +2 more secondary outcomes
Study Arms (2)
erector spinae plane (ESP) block group ( (E) group)
ACTIVE COMPARATORUnder 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) )
ACTIVE COMPARATORUnder 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig University hospital
Zagazig, Sharqia Province, 44511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A shaker, lecturer
Zagazig University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of anaesthesia and intensive care
Study Record Dates
First Submitted
December 22, 2021
First Posted
March 18, 2022
Study Start
January 15, 2021
Primary Completion
November 15, 2023
Study Completion
December 15, 2023
Last Updated
July 12, 2023
Record last verified: 2023-07