Erector Spinae Plane Block in Post-herpetic Neuralgia

NCT04546334 | Completed

• 1 other identifier: 34043/08/20
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postherpetic Neuralgia

Keywords

Herpes Zoster; Postherpetic neuralgia; Erector spina plane block

Outcome Measures

Primary Outcomes (1)

• 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)

  within 3 months of theinjection

Secondary Outcomes (1)

• The frequency of pain

  within 3 months of theinjection

Study Arms (3)

Group A

EXPERIMENTAL

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

Drug: Medical treatment; Procedure: Sham Erector Spinae block

Group B

EXPERIMENTAL

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.

Drug: Medical treatment; Procedure: Real Erector Spinae block

Group C

EXPERIMENTAL

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.

Drug: Medical treatment; Procedure: Real Erector Spinae block with magnesium sulphate

Interventions

Medical treatment DRUG

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

Group A; Group B; Group C

Real Erector Spinae block PROCEDURE

Ultrasound guided Erector spinae plane block with injection of local anesthetic bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose)

Group B

Real Erector Spinae block with magnesium sulphate PROCEDURE

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))

Group C

Sham Erector Spinae block PROCEDURE

Ultrasound guided Erector spinae plane block with injection ofnormal saline

Group A

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Sameh Abdelkhalik, M.D

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 14, 2020
• Study Start: September 26, 2020
• Primary Completion: June 19, 2021
• Study Completion: June 19, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 6 months after approval of the publication of the trial.
• Access Criteria: Contact the principal investigator

Locations

EG (1)