Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04546334 |
| Other study ID # |
34043/08/20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 26, 2020 |
| Est. completion date |
June 19, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
