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NCT Number: NCT06412406

Comparison Between External Oblique Intercostal Plane Block and the Transversus Abdominis Plane Block in Paraumbilical Hernia Repair as Analgesia for Intraoperative and Postoperative Pain.

AIM OF STUDY:

Comparison between effect of external oblique intercostal plane block and the Oblique subcostal transversus abdominis plane block in paraumbilical hernia repair as analgesia for intraoperative and postoperative pain.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A paraumbilical hernia is a hole in the connective tissue of the abdominal wall in the midline with close approximation to the umbilicus. If the hole is large enough there can be protrusion of the abdominal contents, including omental fat and/or bowel. These defects are usually congenital and are not noticed until they slowly enlarge over an individual's life time and abdominal contents herniate through the hole creating either pain or a visible lump on the abdominal wall. If abdominal contents get incarcerated (or stuck) in the hole this can cause pain. If the abdominal contents become strangulated by losing their blood supply from pinching or twisting those tissue will die. If it is omental fat this will cause pain and could potentially lead to an infection. If the strangulated contents are bowel then in addition to pain the individual will develop a bowel obstruction. And if the dead bowel is not surgically removed in an emergent fashion the condition could be fatal.

Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism and respiratory complications and prolongs the hospital stay. This pain is routinely managed using opiates, which are associated with several side effects, including excessive sedation and postoperative nausea and vomiting (PONV) which may increase hospital stay durations. Transversus abdominis plane (TAP) block is a regional anesthetic technique that has gradually become an alternative for postoperative pain control during laparoscopic abdominal surgeries. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall.

the subcostal transversus abdominis plane block (TAP) targets the upper abdominal wall.

The EOI block represents an important modification that cover the upper lateral abdominal wall.

Oblique subcostal transversus abdominis plane (OSCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall,specifically from T6 to L1. The OSCTAP has been described that can be performed to provide analgesia for abdominal surgery extending above the umbilicus.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2
  • patients with the American Society of Anesthesiologists (ASA) physical status I/II
  • Patients scheduled for elective paraumbilical hernia

Exclusion criteria

  • 1-Known hypersensitivity to the study drugs. 2-Body Mass Index > 40 kg/m2. 3- Inability to accurately describe postoperative pain to investigators. 4-Opioid tolerance or dependence. 5-Preexisting history of chronic pain. 6-History of renal, liver, cardiac, neuropsychiatric disorder problems. 7-Bleeding or coagulation abnormality. 8-Patients who received any analgesic 24 h before surgery 9-Patients who have difficulty understanding the study protocol

Treatment and study plan

External Oblique Intercostal (EOI) block

Procedure

EOI block technique A linear ultrasound transducer placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib, The transducer was then rotated so the cranial end was directed slightly medially and the caudal end laterally to produce a paramedian sagittal oblique view with a short-axis view of the ribs, The following structures were identified, from superficial to deep: subcutaneous tissue, external oblique muscle, intercostal muscles between ribs, pleura, and lung. The skin entry point for the injection was cranial to the sixth rib level just medial to the anterior axillary line, with ultrasound opaque needle advanced in plane from a superomedial-to-inferolateral direction, through the external oblique muscle hydrodissecting the tissue plane between the sixth and seventh ribs, and then the needle was directed caudally toward the eighth rib. and inject 20 ml volume of (0.25 % bupivacaine).

Transversus abdominis plane (TAP) block

Procedure

TAP block technique:

abdominal skin will be prepared and covered with sterile drapes. The needle can be introduced by multiple punctures along the oblique subcostal line from the xiphoid process towards the anterior part of the iliac crest (18) . Thus, LA will be injected in the TAP along this line provides both upper and lower abdominal wall analgesia. The OSCTAP block more consistently covers L1 dermatome. After negative aspiration, a test injection with 1 ml of 0.9% normal saline will be performed to confirm the needle location. and ingect 20 ml volume of (0.25 % bupivacaine). If the intended sensation will not decreased in surgical dermatomes after 30 min, the patient will be regarded to have a failed block and will be excluded from the study.

Primary outcomes

  1. The effect between external oblique intercostal plane block and the transversus abdominis plane block in paraumbilical hernia repair as analgesia for intraoperative and postoperative pain according to numeric rating score (NRS)

    Time frame: baseline

    numeric rating scale : from 0 to 10 0 : no pain

    1 - 3 : mild pain 4 - 6 : moderate pain 7 - 9 : severe pain 10 : worst pain possible

Secondary outcomes

  1. time of the first opioid request

    Time frame: baseline

    time of the first opioid request all over 24 hours postoperatively.

  2. Heart rate

    Time frame: baseline

    heart rate will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.

  3. Mean arterial blood pressure

    Time frame: baseline

    mean arterial blood pressure will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.

  4. time to start ambulation

    Time frame: baseline

    time of the patient first movement will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahim M Mohamed, Professor

CONTACT

[email protected]

01000032655

Mohamed G Hassan, Resident

CONTACT

[email protected]

01068885672

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 14, 2024
Registry last updated
Jun 6, 2024

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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