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Not yet recruitingNCT06304116Updated Mar 15, 2024

Effect of Lidocaine Block in Traumatic Brain Injury

An interventional study of Rehabilitation therapy and Stellate ganglion block in Traumatic Brain Injury, sponsored by Muhammad. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Muhammad · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Read the detailed description

Dysphagia, or swallowing difficulty, is a common symptom in Traumatic Brain Injury Patients. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury;
  • presence of no contraindication for Stellate Ganglion Block;
  • with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders.
  • informed consent form was obtained from the patient's family members, indicating their full - understanding of the study and agreement to participate.

Exclusion criteria

Exclusion Criteria:

  • unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
  • complicated with other intracranial lesions, such as stroke;
  • with severe consciousness disorders caused by other diseases.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Rehabilitation therapy+Stellate ganglion block

    The study lasted 10 days for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Based on the invention above, the patients in the observation group were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)

    Behavioral: Rehabilitation therapy · Procedure: Stellate ganglion block · Drug: Lidocaine Hydrochloride

  • Placebo comparator
    Rehabilitation therapy+Placebo

    The study lasted 10 days for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.

    Behavioral: Rehabilitation therapy · Procedure: Stellate ganglion block

Interventions

  • BehavioralRehabilitation therapy

    During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.

  • ProcedureStellate ganglion block

    The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.

  • DrugLidocaine Hydrochloride

    Based on the invention above, the patients in the observation group were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.

05

What researchers measure

Primary outcomes

  1. Penetration-Aspiration Scale

    Penetration-Aspiration Scale is used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food enter the airway and caused penetration or aspiration during the swallowing process. As the level increases, the severity of dysphagia also increases. The score ranges 1 to 8.

    Time frame: day 1 and day 10

Secondary outcomes

  1. Modified Barthel Index

    The activities of daily living of patients will be assessed using the modified Barthel Index . The scale includes 10 items such as feeding, bathing, walking, dressing. Each item is rated on a 4-point scale based on the level of assistance required, with a total score of 100 points. There is a positive correlation between activities of daily living and the final score.The score ranges 1 to 100.

    Time frame: day 1 and day 10

  2. Swallowing duration

    The time duration that the patient swallowed the contrast agent under Videofluoroscopic Swallowing Study the is recorded.Unit: seconds.

    Time frame: day 1 and day 10

  3. Functional Oral Intake Scale

    During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability.

    Time frame: day 1 and day 10

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06304116
Lead sponsor
Muhammad
Responsible party
Muhammad (Research Director, Ahmadu Bello University Teaching Hospital) — Sponsor-investigator
First posted
Mar 12, 2024
Start date
Mar 2024 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Lavie Ce, Master
Contact
zenghongjixx@qq.com
15333828388
Nieto Luis, Master
study director · Site Coordinator of United Medical Group

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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