Erector Spinae Plane Block in Post-herpetic Neuralgia

NCT ID: NCT04546334

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-26
• Study Completion Date: 2021-06-19

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.

Conditions

Postherpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Group A

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 Type: EXPERIMENTAL

Medical treatment

Intervention Type: DRUG

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

Sham Erector Spinae block

Intervention Type: PROCEDURE

Ultrasound guided Erector spinae plane block with injection ofnormal saline

Group B

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 Type: EXPERIMENTAL

Medical treatment

Intervention Type: DRUG

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

Real Erector Spinae block

Intervention Type: 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 C

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.

Group Type: EXPERIMENTAL

Medical treatment

Intervention Type: DRUG

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

Real Erector Spinae block with magnesium sulphate

Intervention Type: 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))

Interventions

Medical treatment

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

Intervention Type: DRUG

Real Erector Spinae block

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

Real Erector Spinae block with magnesium sulphate

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

Sham Erector Spinae block

Ultrasound guided Erector spinae plane block with injection ofnormal saline

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Abdelkhalik Ahmed Ismaiel

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Abdelkhalik, M.D

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta University hospitals

Tanta, , Egypt

Countries

Egypt

Other Identifiers

34043/08/20

Identifier Type: -

Identifier Source: org_study_id