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Completed

NCT Number: NCT07522632

Wearable Device to Assess Mobility After Anterior Iliac Grafting Covered With a Regional Block Technique Transversus Abdominis Plane Block

This study aimed to assess the effect of adding regional technique transversus abdominis plane (TAP) block on postoperative mobilization following anterior iliac bone grafting.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

Bone grafting or bone harvesting is a procedure to augment deficient bone tissue and is widely used in a number of oral and maxillofacial procedures such as reconstructive surgical interventions.

The role of regional anaesthesia in the prevention of central sensitization occurs when an effective nociceptive regional block prevents pain signals from being conducted from the surgical site to the central nervous system, preventing the development of chronic pain and persistent postsurgical pain (PPP).

The transversus abdominis plane (TAP) block permits a sensory block of the lower 6 thoracic and L1 ventral rami. Imaging studies on cadavers and volunteers have demonstrated the spread of solution in a plane between both muscles, with a subsequent sensory blockade from T8 to L1.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adolescent until age range above 13 years old to ensure cooperation during data collection and adults with requirement to anterior iliac crest bone grafting for intraoral grafting.
  • Having no tumour or trauma in the lower limbs or ilium
  • Having no any other neural or muscular disorder which may merge with gait disturbance
  • Having no cognitive deficiency which may prevent understanding and performing of the study protocol.

Exclusion criteria

  • Patients with rheumatic disorders, low back pain, prosthesis of the hip or knees or previous iliac crest surgery.
  • Medical exclusion criteria are severe bronchopulmonary disease and cardiac problems affecting exercise tolerance, blood-clotting impairment, known allergy to the trial drugs, abdominal wall infection, morbid obesity (˃38 kg/m2).
  • Reported allergy to any of the drugs used.
  • Failure to follow up the accelerometry-derived data.

Treatment and study plan

Transversus abdominis plane block

Other

Patients received the transversus abdominis plane block in-addition to the regular General Anaesthesia protocols

Primary outcomes

  1. Difference in Distance

    Time frame: Third week postoperatively

    Difference in Distance in meters totally covered through one week preoperative and third week postoperative.

Secondary outcomes

  1. Rate of increase in Distance

    Time frame: Third week postoperatively

    Rate of increase in Distance was recorded three weeks postoperative

  2. Rate of increase in number of steps

    Time frame: Third week postoperatively

    Rate of increase in number of steps was recorded three weeks postoperative

  3. Time in minutes to start walking after full recovery

    Time frame: 12 hours postoperatively

    Patient was encouraged directly through the first 12 hours postoperatively to walk supervised 20 steps corridor for the first time.

  4. Need of using walking aid

    Time frame: Third week postoperatively

    Need of using walking aid was recorded in the first three weeks postoperatively

  5. Time in hours to develop worst pain

    Time frame: 24 hours postoperatively

    Time in hours to develop worst pain was recorded during rest and motion in the first 24 hours postoperative.

  6. Duration of the bone harvesting procedure

    Time frame: Intraoperatively

    Duration of the bone harvesting procedure was recorded from the incision until wound closure.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Wearable Device to Assess Mobility After Anterior Iliac Grafting Covered With a Regional Block Technique Transversus Abdominis Plane Block: Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

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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