Ultrasound guided intercostal nerve block using pulsed radiofrequency in management of thoracic postherpetic neuralgia

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000941662
• Date of registration: 03/09/2014
• Prospective Registration: Yes
• Primary sponsor: Mohamed Y. Makharita
• Public title: Ultrasound guided intercostal nerve block using pulsed radiofrequency in management of thoracic postherpetic neuralgia
• Scientific title: Ultrasound guided intercostal nerve block using pulsed radiofrequency in management of thoracic postherpetic neuralgia (PHN) in adult patients who had chest wall PHN at T2-T11 of more than 6 months duration, who had moderate and severe pain (VAS more than 30 mm).
• Date of first enrolment: 25/09/2014
• Target sample size: 50
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000941662.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: Dr Salma El Sayed Abd Elsalam Ahmed

• Name: Dr Salma El Sayed Abd Elsalam Ahmed

Key inclusion & exclusion criteria

Inclusion criteria: Adult patients who had chest wall PHN at T2-T11 of more than 6 months duration, who had moderate and severe pain (VAS more than 30 mm).
Exclusion criteria: patient refusal, patients with mild pain,Presence of psychiatric illness. and infection at site of injection. Patients with history of renal, hepatic diseases, coagulopathy, diabetes, steroid therapy, malignancies and patients taking chemo and/or radiotherapy will be excluded

Age minimum: 30 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Pain management

Neurological - Other neurological disorders

post-herpetic neuralgia;
post-herpetic neuralgia

Intervention(s)

The affected thoracic dermatome first will be determined. In addition to the affected dermatome, one dermatome above and below will be the therapeutic targets of this study. Ultrasound guided localization of targets Intercostal nerve (ICN) at the angulus costae then sensory stimulation of the nerve roots with paresthesia response in the dermatome distribution of the affected nerve root using (Neurotherm Rediofrequancy machine 1100 at 50 HZ using a 22-gauge 10 cm radiofrequency needle with 5 mm active tip) . In the active group after sensory stimulation patients will receive 1 ml xylocaine 2% locally infilterated for each nerve root and wait for one minute. Then the patients will receive 2 cycles pulsed radiofrequency (PRF) 42 C for 120 second for ICN at the angulus costae for the affected thoracic nerves. These therapeutic modalities will be applied to the affected dermatome and to adjacent upper and lower one The total duration of the procedure will take about thirty minutes and will be undertaken on a single occasion only. patients will receive pregabalin in a dose of 150 mg twice daily orally. Their pain score will be evaluated in each visit. Once patients reported mild pain (VAS less than 30), the pregabalin dose will be reduced by 75 mg every 3 days provided that pain score remained less than 30 with each reduction. If the VAS value will increase to more than 30, the patient will be returned to the last controllable pregabalin dose and the result will be recorded in the patient diary. Acetaminophen will be available as rescue analgesia in a dose of 1,000 mg orally on request. For those with persistent pain more than 30, a maximum daily dose of 4,000 mg will be allowed.

Primary Outcome(s)

Quality of life[Quality of life will be evaluated using self-evaluation questionnaires (SF-36) at 1, 3, 6 and 12 months]

Patients will be evaluated for pain severity using Visual Analogue Scale (VAS), (100 mm unmarked line in which 0 equal no pain and 100 mm means worst pain imaginable)[before the block (basal), , every 2 weeks after the procedure for 6 months and every 1 month for another 6 months. ]

Secondary Outcome(s)

Analgesic consumption was assessed on a patient daily diary [before the block (basal), , every 2 weeks after the procedure for 6 months and every 1 month for another 6 months.]

Secondary ID(s)

none

Secondary Sponsor(s)

Zainab Mahmoud Sonbul

Mahmoud Abdel Latif Mohamed

Hanaa Mahmoud Elbendary

Ethics review

Status: Approved
Approval date:
Contact:

medical research ethical committe- Mansoura university