Transversalis Fascia Plane vs Ilioinguinal and Iliohypogastric Nerve Block for the Treatment of CPIP
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDiskapi Teaching and Research Hospital
About this trial
The aim of this study was to compare the efficacy of ultrasound (US)-guided transversalis fascia plane block (TFP) and ilioinguinal (II) and iliohypogastric (IH) nerve block in the treatment of chronic post-herniorrhaphy inguinal pain (CPIP) refractory to conservative treatments. For this evaluation, a numerical rating scale (NRS) will be used before and after both interventions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Complaints of inguinal pain >12 weeks post-herniorrhaphy surgery
>18 years of age
Failure of conservative pain management
Disqualifiers
Other causes of inguinal pain (haematoma, infection, tubo-ovarian disease, abscess, etc., gynaecological, urological and organic pathologies after inguinal hernia, etc.)
Pregnancy
Coagulopathy, antiaggregant/anticoagulant/antiplatelet use
Unstable psychiatric illness
Trial design
Design model
Parallel
Treatments tested in this trial
ultrasound-guided transversalis fascia plane block
Procedure/SurgeryWith the patient in the lateral decubitus position, an 8-12 Hz linear ultrasound (US) probe is placed transversely over the iliac crest. The external oblique (EO), internal oblique (IO) and transversus abdominis (TA) muscles are identified so that the abdominal muscles are in the field of view. The TA muscle is then advanced posteriorly until it tapers to the thoracolumbar fascia with its aponeurosis adjacent to the quadratus lumborum (QL) muscle. The 22 gauge block needle is advanced in plane with the US probe. After placing the needle tip in the virtual triangular plane between the posterior edge of the TA muscle, the QL and the underlying transversalis fascia, 4 mL of 0.5% bupivacaine + 2 mL of a total of 8 mg dexamethasone + 4 mL of saline are injected for a total volume of 10 mL.
ultrasound-guided ilioinguinal and iliohypogastric nerve block group
Procedure/SurgeryWith the patient in the supine position, an 8-12 Hz linear ultrasound (US) probe is placed medial and cephalal to the anterior superior iliac spine (ASIS), transversely between the ASIS and the umbilicus. The external oblique (EO), internal oblique (IO) and transversus abdominis (TA) muscles are identified so that the abdominal muscles are in the field of view. The II-IH nerves are hyperechogenic in the fascial plane between the IO and TA muscles. A 22 gauge block needle is advanced in plane with the US probe. When the needle tip is advanced to the II and IH nerves, 4 mL of 0.5% bupivacaine + 2 mL total 8 mg dexamethasone + 4 mL saline is injected for a total volume of 10 mL.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: transversalis fascia plane block groupActive comparator 1 intervention
Group B: ilioinguinal and iliohypogastric nerve block groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numerical rating scale (NRS)
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Time frame
Change from baseline to 1st and 3rd month after treatmentSecondary outcomes
1
procedure-related adverse events
Any adverse events that occur during and after the TFP and II-IH block procedures will be recorded.
Time frame
Change from baseline to 1st and 3rd month after treatment2
patient satisfaction likert scale
Patient satisfaction is measured using a five-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied).
Time frame
Change from baseline to 30 minutes after procedureSponsors and contacts
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Source ClinicalTrials.gov