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

NCT04941170 | Completed Phase 4

• 1 other identifier: RC 2-6-2021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Hernia, Umbilical

Keywords

Open umbilical hernia; Transversus abdominis plane block; Erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• total morphine consumption.

  Amount of morphine used as rescue analgesia post-operatively.

  in first 24 hours

Secondary Outcomes (3)

• Intraoperative fentanyl consumption

  From the start of operation till its end up to 3 hours.

• time of first analgesic request

  in 24 hours

• pain severity evaluation.

  at PACU admission , 30 minutes , 2 hours , 4 hours , 8 hours ,12 hours ,18 hours and 24 hours post operative

Study Arms (2)

Group (T)

ACTIVE COMPARATOR

receive preoperative bilateral ultrasound-guided oblique subcostal transversus abdominis plane block.

Drug: Bupivacain; Drug: Bupivacaine

Group (E)

ACTIVE COMPARATOR

receive preoperative bilateral ultrasound-guided erector spinae plane block.

Drug: Bupivacain; Drug: Bupivacaine

Interventions

Bupivacain DRUG

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.

Also known as: oblique subcostal transversus abdominis plane block

Group (E); Group (T)

Bupivacaine DRUG

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.

Also known as: erector spinae plane block

Group (E); Group (T)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

Location

MeSH Terms

Conditions

Pain; Hernia, Umbilical

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• fatma ah abdelfatah, MD

  Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: June 28, 2021
• Study Start: June 29, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 15, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

EG (1)