Wearable DeviceNCT07522632
Wearable Device to Assess Mobility After Anterior Iliac Grafting Covered With a Regional Block Technique Transversus Abdominis Plane Block
A study testing Transversus Abdominis Plane Block in people with Wearable Device and Mobility, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to assess the effect of adding regional technique transversus abdominis plane (TAP) block on postoperative mobilization following anterior iliac bone grafting. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Wearable Device, Mobility, Anterior Iliac Grafting
- What is being tested?
- Transversus Abdominis Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Wearable Device, Mobility, Anterior Iliac Grafting, Regional Block Technique, Transversus Abdominis Plane Block
- Being tested
- Transversus Abdominis Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane BlockOther
Patients received the transversus abdominis plane block in-addition to the regular General Anaesthesia protocols
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | No intervention | Patients with requirement to anterior iliac crest bone grafting for intraoral transplantation without intervention. |
| Group (B) | Experimental | Patients received the transversus abdominis plane block in-addition to the regular General Anaesthesia protocols. Receives: Other: Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Distance
Difference in Distance in meters totally covered through one week preoperative and third week postoperative.
Measured: Third week postoperatively
Secondary outcomes (6)
Rate of increase in Distance
Rate of increase in Distance was recorded three weeks postoperative
Measured: Third week postoperatively
Rate of increase in number of steps
Rate of increase in number of steps was recorded three weeks postoperative
Measured: 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.
Measured: 12 hours postoperatively
Need of using walking aid
Need of using walking aid was recorded in the first three weeks postoperatively
Measured: 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.
Measured: 24 hours postoperatively
Duration of the bone harvesting procedure
Duration of the bone harvesting procedure was recorded from the incision until wound closure.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jul 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wearable DeviceStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalkahar Shawki, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522632
- Sponsor's protocol ID
- 04-02-2024
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Device to Assess Mobility After Anterior Iliac Grafting Covered With a Regional Block Technique Transversus Abdominis Plane Block: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07522632
- Acronym / sponsor ID
- 04-02-2024
- Conditions
- Wearable Device, Mobility, Anterior Iliac Grafting, Regional Block Technique, Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to assess the effect of adding regional technique transversus abdominis plane (TAP) block on postoperative mobilization following anterior iliac bone grafting.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | No intervention | –Patients with requirement to anterior iliac crest bone grafting for intraoral transplantation without intervention. |
| Group (B) | Experimental | Other: Transversus Abdominis Plane BlockPatients received the transversus abdominis plane block in-addition to the regular General Anaesthesia protocols. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus Abdominis Plane BlockPatients received the transversus abdominis plane block in-addition to the regular General Anaesthesia protocols | Other | Group (B) |
Primary outcome
Difference in Distance
Time frame: Third week postoperatively
Difference in Distance in meters totally covered through one week preoperative and third week postoperative.
6 secondary outcomes
Rate of increase in Distance
Time frame: Third week postoperatively
Rate of increase in number of steps
Time frame: Third week postoperatively
Time in minutes to start walking after full recovery
Time frame: 12 hours postoperatively
Need of using walking aid
Time frame: Third week postoperatively
Time in hours to develop worst pain
Time frame: 24 hours postoperatively
Duration of the bone harvesting procedure
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abdominis Plane Block in people with Wearable Device and Mobility, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Distance (time frame: Third week postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.