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

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

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

Study Overview

• Status: Completed
• Conditions: Mobility; Transversus Abdominis Plane Block; Wearable Device; Anterior Iliac Grafting; Regional Block Technique
• Intervention / Treatment: Other: Transversus Abdominis Plane Block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group (A); Patients with requirement to anterior iliac crest bone grafting for intraoral transplantation without intervention.
Experimental: Group (B); Patients received the transversus abdominis plane block in-addition to the regular General Anaesthesia protocols.	Other: Transversus Abdominis Plane Block; Patients received the transversus abdominis plane block in-addition to the regular General Anaesthesia protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Distance	Difference in Distance in meters totally covered through one week preoperative and third week postoperative.	Third week postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of increase in Distance	Rate of increase in Distance was recorded three weeks postoperative	Third week postoperatively
Rate of increase in number of steps	Rate of increase in number of steps was recorded three weeks postoperative	Third week postoperatively
Time in minutes to start walking after full recovery	Patient was encouraged directly through the first 12 hours postoperatively to walk supervised 20 steps corridor for the first time.	12 hours postoperatively
Need of using walking aid	Need of using walking aid was recorded in the first three weeks postoperatively	Third week postoperatively
Time in hours to develop worst pain	Time in hours to develop worst pain was recorded during rest and motion in the first 24 hours postoperative.	24 hours postoperatively
Duration of the bone harvesting procedure	Duration of the bone harvesting procedure was recorded from the incision until wound closure.	Intraoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): February 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 04-02-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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