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NCT Number: NCT04941170

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: oblique subcostal transversus abdominis plane block

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.

Other names: erector spinae plane block

Primary outcomes

  1. total morphine consumption.

    Time frame: in first 24 hours

    Amount of morphine used as rescue analgesia post-operatively.

Secondary outcomes

  1. Intraoperative fentanyl consumption

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

    Intraoperative fentanyl dosage (μg)

  2. time of first analgesic request

    Time frame: in 24 hours

    first time of analgesia used after operation.

  3. pain severity evaluation.

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

    by verbal numerical rating scale (VNRS) at rest and cough (0 = no pain, 10 = unbearable pain).

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2021
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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