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Cervical Epidural and Stellate Ganglion Block in Upper Limb Complex Regional Pain Syndrome

Primary Purpose

Stellate Ganglion Block, Cervical Epidural, Complex Regional Pain Syndromes

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound guided Stellate ganglion block
unilateral cervical epidural
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stellate Ganglion Block

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged more than 21 years old of both sexes with American Society of Anesthesiologists I and II Upper limb trauma patients with pain disproportionate to the degree of tissue injury and persists beyond the normal expected time for tissue healing Patients diagnosed as (Complex Regional Pain Syndrome ) based on Budapest criteria There should be at least one symptom or sign in three of the four previous categories that can not be explained by other diagnosis. The average daily pain intensity required on Numerical Rating Scale is 7 or more for at least 3 months despite of standard therapy which includes: (pharmacologic therapy Non-steroidal anti-inflammatory drugs, Antiepileptic drugs(AEDs), antidepressants), as well as physical therapy and psychiatric care. Exclusion Criteria: Patient refusal Patients with unstable psychological or psychiatric conditions, including: untreated bipolar disorder, post-traumatic stress disorder, major depression, severe personality disorder and psychotic illness Patients have recently undergone major interventional pain procedures, such as nerve blocks or implantable therapies. Patients with known drug dependency or substance use disorder specifically related to ketamine or other psycho-stimulant drugs Patients with previous severe reactions, contraindication or allergy to ketamine Patients with hepatic or renal impairment Active infection at the injection site Known allergies to medications Previous neck surgeries Raynaud's disease or Raynaud's phenomena Coagulopathy

Sites / Locations

  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ultrasound guided Stellate ganglion block

unilateral cervical epidural

Arm Description

The procedure is going to be the anterior paratracheal approach on the cervical sympathetic chain

The patient is placed in prone position, with stabilization of the forehead on a padded support

Outcomes

Primary Outcome Measures

The percent on satisfactory relief of pain
Numerical rating scales (NRS) is an 11-Point Scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being "no pain" and 10 being "the worst pain imaginable. NRS was measured before, immediately after injection, 3 and 6 month post injection.

Secondary Outcome Measures

The degree of chronic pain using Brief Pain Inventory
Brief Pain Inventory short form (BPI-SF) questionnaire. It is a nine item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, normal work, relations with other persons, sleep, and enjoyment of life on a 10 Point Scale BPI-SF was measured before, immediately after injection, 3 and 6 month post injection
The incidence of complication
complications as hypotension, headache and neck pain

Full Information

First Posted
July 19, 2023
Last Updated
August 30, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05970146
Brief Title
Cervical Epidural and Stellate Ganglion Block in Upper Limb Complex Regional Pain Syndrome
Official Title
Comparison Between Cervical Epidural and Stellate Ganglion Block in Management of Complex Regional Pain Syndrome of the Upper Limb A Prospective Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the efficacy of two regimens of management in relieving chronic refractory pain in patients with upper limb complex regional pain syndrome after orthopedic trauma
Detailed Description
Ideal therapy for Complex Regional Pain Syndrome is multimodal with the use of physical therapy, psychotherapy, and pharmacologic therapy to complement interventional procedures. Within pharmacotherapy, drugs most often utilized include non steroidal anti-inflammatory drugs (NSAIDs), gamma-aminobutyric acid receptor agonists (i.e., gabapentin, pregabalin), and N-methyl-D-aspartate (NMDA) receptor antagonists (i.e., Ketamine). In complex Regional Pain Syndrome treatment, stellate ganglion block (SGB) is a well-established method of nerve blockade of the sympathetic ganglia in the lower cervical and upper thoracic region. Epidural block have differential block as sensory, motor, and sympathetic. Nerve functions are blunt at different rates and to different degrees. Sensory block occurs with a lower concentration of Local anathesia and develops faster than motor block with coexisting sympathectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stellate Ganglion Block, Cervical Epidural, Complex Regional Pain Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided Stellate ganglion block
Arm Type
Experimental
Arm Description
The procedure is going to be the anterior paratracheal approach on the cervical sympathetic chain
Arm Title
unilateral cervical epidural
Arm Type
Experimental
Arm Description
The patient is placed in prone position, with stabilization of the forehead on a padded support
Intervention Type
Drug
Intervention Name(s)
Ultrasound guided Stellate ganglion block
Intervention Description
Under visualization with ultrasound, a 22-gauge, 5-cm needle inserted perpendicular to the skin to rest anteriorly to the precervical fascia. 6 mL lidocaine 0.125% and 8 mg dexamethasone in a total volume of 8 mL is used. After injection of a 0.5-mL test dose to exclude intravascular positioning, the remainder of the appropriate dose was administered. The patient will be encouraged to lie flat for 3 minutes after the injection and then to sit up.
Intervention Type
Drug
Intervention Name(s)
unilateral cervical epidural
Intervention Description
Aseptic betadine skin preparation will be performed and sterile drapes will be applied. Local anesthetic infiltration of the skin at C7-T1 interspace will be done using 2-3 mL of lidocaine 2% with guidance of the C-arm an 18-gauge. Tuohy needle will be inserted at C7-T1 interspace and directed towards either right or left epidural recess according to the site of the operation. Identification of entering the epidural space will be confirmed by hanging drop technique. The position of the needle is the confirmed by injection of 1 mL of non-ionized diluted dye (omnipause 300) to confirm unilateral spread of the dye. After that, a test dose was administrated, consisting of 2 mL of 2% lidocaine with 1:200,000 epinephrine.
Primary Outcome Measure Information:
Title
The percent on satisfactory relief of pain
Description
Numerical rating scales (NRS) is an 11-Point Scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being "no pain" and 10 being "the worst pain imaginable. NRS was measured before, immediately after injection, 3 and 6 month post injection.
Time Frame
6 month post injection
Secondary Outcome Measure Information:
Title
The degree of chronic pain using Brief Pain Inventory
Description
Brief Pain Inventory short form (BPI-SF) questionnaire. It is a nine item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, normal work, relations with other persons, sleep, and enjoyment of life on a 10 Point Scale BPI-SF was measured before, immediately after injection, 3 and 6 month post injection
Time Frame
6 month post injection
Title
The incidence of complication
Description
complications as hypotension, headache and neck pain
Time Frame
2 hours post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged more than 21 years old of both sexes with American Society of Anesthesiologists I and II Upper limb trauma patients with pain disproportionate to the degree of tissue injury and persists beyond the normal expected time for tissue healing Patients diagnosed as (Complex Regional Pain Syndrome ) based on Budapest criteria There should be at least one symptom or sign in three of the four previous categories that can not be explained by other diagnosis. The average daily pain intensity required on Numerical Rating Scale is 7 or more for at least 3 months despite of standard therapy which includes: (pharmacologic therapy Non-steroidal anti-inflammatory drugs, Antiepileptic drugs(AEDs), antidepressants), as well as physical therapy and psychiatric care. Exclusion Criteria: Patient refusal Patients with unstable psychological or psychiatric conditions, including: untreated bipolar disorder, post-traumatic stress disorder, major depression, severe personality disorder and psychotic illness Patients have recently undergone major interventional pain procedures, such as nerve blocks or implantable therapies. Patients with known drug dependency or substance use disorder specifically related to ketamine or other psycho-stimulant drugs Patients with previous severe reactions, contraindication or allergy to ketamine Patients with hepatic or renal impairment Active infection at the injection site Known allergies to medications Previous neck surgeries Raynaud's disease or Raynaud's phenomena Coagulopathy
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aya H Hegazy
Phone
+20 101 192 3265
Email
Ahhegazy1993@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
The data will be available upon a reasonable request from the corresponding author
IPD Sharing Access Criteria
after the end of study for one year

Learn more about this trial

Cervical Epidural and Stellate Ganglion Block in Upper Limb Complex Regional Pain Syndrome

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