NCT07522632

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 4, 2026

Last Update Submit

April 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in Distance

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

    Third week postoperatively

Secondary Outcomes (6)

  • Rate of increase in Distance

    Third week postoperatively

  • Rate of increase in number of steps

    Third week postoperatively

  • Time in minutes to start walking after full recovery

    12 hours postoperatively

  • Need of using walking aid

    Third week postoperatively

  • Time in hours to develop worst pain

    24 hours postoperatively

  • +1 more secondary outcomes

Study Arms (2)

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.

Other: Transversus Abdominis Plane Block

Interventions

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

Group (B)

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with rheumatic disorders, low back pain, prosthesis of the hip or knees or previous iliac crest surgery.
  • Reported allergy to any of the drugs used.
  • Failure to follow up the accelerometry-derived data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.D.S of Oral and Maxillofacial Surgery Department, Ain-Shams University, Cairo, Egypt.

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start

July 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations