Erector Spinae Plane Block in Post-herpetic Neuralgia

The Effect of Erector Spinae Plane Block on the Relief of Pain of Post-herpetic Neuralgia: Randomized Controlled Study

Sponsors

Lead Sponsor: Tanta University

Source Tanta University
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.

1. Demographic data: including age, gender, associated morbidities, and site of post-herpetic neuralgia.

2. 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)

3. Frequency of pain

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

5. Dose of pregabalin consumed per day to relief pain

6. Dose of other analgesics required to control pain.

Overall Status Recruiting
Start Date September 26, 2020
Completion Date May 25, 2021
Primary Completion Date May 25, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The efficacy of pain relief within 3 months of theinjection
Secondary Outcome
Measure Time Frame
The frequency of pain within 3 months of theinjection
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: Medical treatment

Description: routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol)

Intervention Type: Procedure

Intervention Name: Real Erector Spinae block

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)

Arm Group Label: Group B

Intervention Type: Procedure

Intervention Name: Real Erector Spinae block with magnesium sulphate

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))

Arm Group Label: Group C

Intervention Type: Procedure

Intervention Name: Sham Erector Spinae block

Description: Ultrasound guided Erector spinae plane block with injection ofnormal saline

Arm Group Label: Group A

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

Gender: All

Minimum Age: 21 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Sameh Abdelkhalik, M.D Principal Investigator Faculty of Medicine, Tanta University
Overall Contact

Last Name: Sameh Abdelkhalik, M.D

Phone: +201002977048

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Tanta University hospitals Sohair Soliman, Professor 00201283929049 [email protected]
Location Countries

Egypt

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Tanta University

Investigator Full Name: Sameh Abdelkhalik Ahmed Ismaiel

Investigator Title: Dr

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Group A

Type: Experimental

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

Label: Group B

Type: Experimental

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.

Label: Group C

Type: Experimental

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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Triple (Participant, Investigator, Outcomes 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.

Source: ClinicalTrials.gov