U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Preemptive Analgesia

U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Pre-emptive Analgesia for Open Umbilical Hernia Repair; Randomized, Double-blinded Controlled Trial

Administration of opioids for the treatment of acute pain after open umbilical hernia repair is associated with many side effects. Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region.TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen.

Study Overview

• Status: Completed
• Conditions: Pain; Hernia, Umbilical
• Intervention / Treatment: Drug: Bupivacain; Drug: Bupivacaine

Detailed Description

TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique and decreases postoperative pain and opioid consumption.

Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region. However, its first use was for the treatment of chronic pain, but recently it has been used as a postoperative regional analgesia technique in different surgeries from the shoulder to hip regions (3-4) The present study will be carried out to compare the preemptive analgesic efficacy between the ultrasound-guided bilateral ESP block versus bilateral oblique subcostal TAP block on patients undergoing open umbilical hernia repair.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Elqalyoubea
    • Banha, Elqalyoubea, Egypt, 13511
      • Banha Faculity of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. American Society of anesthesiologists I-II, scheduled for open umbilical hernia repair.
2. Age range of 18-65 years.

Exclusion Criteria:

1. patient refusal.
2. Patients belonging to ASA grade III and grade IV.
3. Extreme obesity (BMI >35).
4. hepatic or renal insufficiency.
5. preoperative cognitive dysfunction or communication disorder.
6. allergy to amide-type local anaesthetics.
7. back puncture site infection.
8. Coagulation disorders, pregnancy, drug abusers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group (T); receive preoperative bilateral ultrasound-guided oblique subcostal transversus abdominis plane block.	Drug: Bupivacain; Ultrasound-guided oblique subcostal transversus abdominis plane block will be performed in the supine position under strict aseptic precautions. placing a linear high-frequency ultrasound probe obliquely near the costal margin and xiphoid process On confirming the placement of the needle in the correct target space, 1 mL of 0.25% bupivacaine will be injected to hydro-dissect the fascia layer between the RA and TA. After confirming the separation of the transversus abdominis fascia plane, the remaining 19 mL of 0.25% bupivacaine will be administered, advancing the needle infero-laterally parallel to the subcostal margin. A similar procedure will be performed on the contralateral side of the abdomen with an injection of another 20 mL of 0.25% bupivacaine.; Other Names: oblique subcostal transversus abdominis plane block; Drug: Bupivacaine; Ultrasound-guided erector spinae plane block will be performed in the sitting position. T7 spinous process will be located To perform the block. The tip of the T7 transverse process will be then identified using the ultrasound probe that is placed in a transverse orientation The ultrasound transducer will then be placed in a longitudinal orientation 2-3 cm lateral to the midline in a longitudinal orientation to identify the hyperechoic line of the transverse process with its associated acoustic shadow. After local anaesthetic infiltration, the block needle will be inserted in a craniocaudal direction until contact will be achieved with the T 7 transverse process where the tip will lay in the inter-fascial plane below the erector spinae muscle. A small bolus of local anaesthetic should be given through the block needle to confirm the proper needle position. A total of 20 mL bupivacaine 0.25% will be injected into the interfacial plane deep to the erector spinae muscle bilaterally.; Other Names: erector spinae plane block
ACTIVE_COMPARATOR: Group (E); receive preoperative bilateral ultrasound-guided erector spinae plane block.	Drug: Bupivacain; Ultrasound-guided oblique subcostal transversus abdominis plane block will be performed in the supine position under strict aseptic precautions. placing a linear high-frequency ultrasound probe obliquely near the costal margin and xiphoid process On confirming the placement of the needle in the correct target space, 1 mL of 0.25% bupivacaine will be injected to hydro-dissect the fascia layer between the RA and TA. After confirming the separation of the transversus abdominis fascia plane, the remaining 19 mL of 0.25% bupivacaine will be administered, advancing the needle infero-laterally parallel to the subcostal margin. A similar procedure will be performed on the contralateral side of the abdomen with an injection of another 20 mL of 0.25% bupivacaine.; Other Names: oblique subcostal transversus abdominis plane block; Drug: Bupivacaine; Ultrasound-guided erector spinae plane block will be performed in the sitting position. T7 spinous process will be located To perform the block. The tip of the T7 transverse process will be then identified using the ultrasound probe that is placed in a transverse orientation The ultrasound transducer will then be placed in a longitudinal orientation 2-3 cm lateral to the midline in a longitudinal orientation to identify the hyperechoic line of the transverse process with its associated acoustic shadow. After local anaesthetic infiltration, the block needle will be inserted in a craniocaudal direction until contact will be achieved with the T 7 transverse process where the tip will lay in the inter-fascial plane below the erector spinae muscle. A small bolus of local anaesthetic should be given through the block needle to confirm the proper needle position. A total of 20 mL bupivacaine 0.25% will be injected into the interfacial plane deep to the erector spinae muscle bilaterally.; Other Names: erector spinae plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total morphine consumption.	Amount of morphine used as rescue analgesia post-operatively.	in first 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	Intraoperative fentanyl dosage (μg)	From the start of operation till its end up to 3 hours.
time of first analgesic request	first time of analgesia used after operation.	in 24 hours
pain severity evaluation.	by verbal numerical rating scale (VNRS) at rest and cough (0 = no pain, 10 = unbearable pain).	at PACU admission , 30 minutes , 2 hours , 4 hours , 8 hours ,12 hours ,18 hours and 24 hours post operative

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: fatma ah abdelfatah, MD, Benha University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2021
• Primary Completion (ACTUAL): November 1, 2021
• Study Completion (ACTUAL): December 15, 2021

Study Registration Dates

• First Submitted: June 19, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (ACTUAL): June 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Erector spinae plane block; Transversus abdominis plane block; Open umbilical hernia
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia, Ventral; Hernia; Hernia, Umbilical; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: RC 2-6-2021

Drug and device information, study documents

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