Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT04546334
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block in Post-herpetic Neuralgia
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
The Effect of Erector Spinae Plane Block on the Relief of Pain of Post-herpetic Neuralgia: Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: