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Erector Spinae Plane Block in Post-herpetic Neuralgia

Primary Purpose

Postherpetic Neuralgia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Medical treatment
Real Erector Spinae block
Real Erector Spinae block with magnesium sulphate
Sham Erector Spinae block
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postherpetic Neuralgia focused on measuring Herpes Zoster, Postherpetic neuralgia, Erector spina plane block

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cases presenting to the Pain Clinic with acute pain due to postherpetic neuralgia in thoracic and/or lumbar dermatomes with a numerical rating scale (NRS) of 6 or more.

Exclusion Criteria:

  • Patients commenced on opioids for any other reason rather than postherpetic neuralgia
  • Secondary bacterial infection at the site of injection
  • Uncontrolled psychiatric illness
  • Uncooperative patients
  • Refusal to participate in the study
  • Diagnosed or suspected coagulopathy
  • Morbid Obese patients with BMI >50 kg/m2
  • Known history of allergy to local anesthetics
  • Platelet count less than 75,000/ cc

Sites / Locations

  • Tanta University hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Patients will be subjected to the routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol) and sham erector spinae plane block

Patients will be subjected to erector spinae block by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose) together with medical treatment.

Patients that will be subjected to erector spinae block by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose with the addition of MgSO4 (equivalent to 100 mg)) together with medical treatment.

Outcomes

Primary Outcome Measures

The efficacy of pain relief
Numerical rating score NRS (0- 10 metric score to assess the severity of pain where 0= no pain and 10 = severe pain)

Secondary Outcome Measures

The frequency of pain
The number of pain attacks (pain score of 4 or more)

Full Information

First Posted
September 9, 2020
Last Updated
July 31, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04546334
Brief Title
Erector Spinae Plane Block in Post-herpetic Neuralgia
Official Title
The Effect of Erector Spinae Plane Block on the Relief of Pain of Post-herpetic Neuralgia: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2020 (Actual)
Primary Completion Date
June 19, 2021 (Actual)
Study Completion Date
June 19, 2021 (Actual)

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
No

5. Study Description

Brief Summary
This randomized clinical study will be carried out on 72 patients admitted to the pain clinic in Tanta University Hospitals with post-herpetic neuralgia. Cases presenting to the Pain Clinic with acute pain due to postherpetic neuralgia in thoracic and/or lumbar dermatomes with numerical rating scale (NRS) of 6 or more and they will be randomly divided, using the closed envelop method, into three equal groups. Group A (24 patients): Patients will be subjected to the routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol) and sham erector spinae plane block Group B (24 patients): Patients will be subjected to erector spinae block by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose) together with medical treatment. Group C (24 patients): Patients that will subjected to erector spinae block by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose with the addition of MgSO4 (equivalent to 100 mg)) together with medical treatment. Primary outcome will be the efficacy of pain relief Secondary outcome will be the frequency of pain and the consumption of analgesics.
Detailed Description
This comparative randomized controlled study will be conducted on 72 patients of both gender suffering from post-herpetic neuralgia and presented at Pain Clinics of Tanta University Hospitals for a period of 9 months (September 2020- June 2021) that will be started immediately after obtaining Ethical Committee approval. An informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only. A total of 72 cases with post herpetic neuralgia will be included in the current study, and they will be randomly divided, using the closed envelop method, into three equal groups. Group A (24 patients): Patients will be subjected to the routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol) and sham erector spinae plane block Group B (24 patients): Patients will be subjected to erector spinae block by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose) together with medical treatment. Group C (24 patients): Patients that will subjected to erector spinae block by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose with the addition of MgSO4 (equivalent to 100 mg)) together with medical treatment. Management of the patients Before intervention, all cases will be subjected to complete history taking, physical examination, and routine laboratory and radiological investigations (if other causes rather than post herpetic neuralgia are suspected). Pre intervention pain will be evaluated by NRS and recorded for all cases. Measurements An assistant resident will help in obtaining and recording our measurements. All the patients will undergo regular follow up visits that will be arranged throughout the upcoming 3 months following injection as every week in the first month, then, every 2 weeks in the next two months. Demographic data: including age, gender, associated morbidities, and site of post-herpetic neuralgia. Duration of analgesia will be defined as the analgesia starting from the performance of the block until the first analgesic requirement or reporting a pain score of 4/10.(9) Frequency of pain Numerical rating score NRS (0- 10 metric score to assess the severity of pain where 0= no pain and 10 = severe pain) Dose of pregabalin consumed per day to relief pain Dose of other analgesics required to control pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
Herpes Zoster, Postherpetic neuralgia, Erector spina plane block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The patients will be blinded to their groups and a sham block will be performed. An anesthesia resident who will not participate in the study and have no subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions. An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in collection of the data of measurements.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients will be subjected to the routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol) and sham erector spinae plane block
Arm Title
Group B
Arm Type
Experimental
Arm Description
Patients will be subjected to erector spinae block by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose) together with medical treatment.
Arm Title
Group C
Arm Type
Experimental
Arm Description
Patients that will be subjected to erector spinae block by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose with the addition of MgSO4 (equivalent to 100 mg)) together with medical treatment.
Intervention Type
Drug
Intervention Name(s)
Medical treatment
Intervention Description
routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol)
Intervention Type
Procedure
Intervention Name(s)
Real Erector Spinae block
Intervention Description
Ultrasound guided Erector spinae plane block with injection of local anesthetic bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose)
Intervention Type
Procedure
Intervention Name(s)
Real Erector Spinae block with magnesium sulphate
Intervention Description
Ultrasound guided Erector spinae plane block with injection of local anesthetic bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose with the addition of MgSO4 (equivalent to 100 mg))
Intervention Type
Procedure
Intervention Name(s)
Sham Erector Spinae block
Intervention Description
Ultrasound guided Erector spinae plane block with injection ofnormal saline
Primary Outcome Measure Information:
Title
The efficacy of pain relief
Description
Numerical rating score NRS (0- 10 metric score to assess the severity of pain where 0= no pain and 10 = severe pain)
Time Frame
within 3 months of theinjection
Secondary Outcome Measure Information:
Title
The frequency of pain
Description
The number of pain attacks (pain score of 4 or more)
Time Frame
within 3 months of theinjection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cases presenting to the Pain Clinic with acute pain due to postherpetic neuralgia in thoracic and/or lumbar dermatomes with a numerical rating scale (NRS) of 6 or more. Exclusion Criteria: Patients commenced on opioids for any other reason rather than postherpetic neuralgia Secondary bacterial infection at the site of injection Uncontrolled psychiatric illness Uncooperative patients Refusal to participate in the study Diagnosed or suspected coagulopathy Morbid Obese patients with BMI >50 kg/m2 Known history of allergy to local anesthetics Platelet count less than 75,000/ cc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Abdelkhalik, M.D
Organizational Affiliation
Faculty of Medicine, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University hospitals
City
Tanta
ZIP/Postal Code
31511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
IPD Sharing Time Frame
6 months after approval of the publication of the trial.
IPD Sharing Access Criteria
Contact the principal investigator

Learn more about this trial

Erector Spinae Plane Block in Post-herpetic Neuralgia

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