Parasacral Ischial Plane Block in Lower Extremity Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBursa Yuksek Ihtisas Training and Research Hospital

About this trial

The parasacral ischial plane block is a novel fascial plane approach targeting the sacral plexus. This technique is technically less challenging and eliminates the requirement for direct visualization of the sacral plexus. The aim of this prospective observational study is to evaluate the efficacy of the conventional sacral plexus block versus the parasacral ischial plane block in patients undergoing lower extremity surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 18-80

ASA I-III

Patients operated on under regional anesthesia

Patients who provided written informed consent

Disqualifiers

Patients with a history of allergy to local anesthetic drugs

Patients with coagulation disorders

Patients with BMI > 40 kg/m²

Presence of infection at the block application site

Trial design

Design model

Parallel

Treatments tested in this trial

  • Parasacral Ischial Plan Block

    Procedure/Surgery

    The sacral plexus is located within a fascial plane formed by the pelvic fascia anteriorly, the sacrum medially, the piriformis and gluteus maximus muscles posteriorly, and the ischium laterally. The piriformis muscle has no attachment to the ischium and attaches to the greater trochanter laterally. A fascial plane exists between the piriformis muscle and the ischium; this fascial plane extends to the sacral plexus. Venkataraju et al. stated that in PIP block demonstrations, the needle should be directed and placed towards the posteromedial surface of the ischium. After bone contact, the medication was injected, and it was observed that the medication spread from under the piriformis muscle towards the sacral plexus.

  • Sacral plexus block

    Procedure/Surgery

    This block, defined by the parasacral approach, targets the exit point of the plexus at the level of the foramen ischiadicum majus. Unlike distal sciatic blocks, blocking at this level includes the posterior cutaneous femoral nerve, superior/inferior gluteal nerve, and pudendal nerve, along with the ischial nerve. In current practice, ultrasonography (USG) has become the "gold standard"; visualizing the neural structures deep to the piriformis muscle by placing the probe between the lateral sacrum and the iliac wing increases the success rate while minimizing the risk of complications.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Parasacral Ischial Plan BlockActive comparator 1 intervention
Group B: Sacral plexus blockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sensory and motor block onset time

This approach is based on the volume-dependent spread of local anesthetic into the plane between the sacral plexus and the deep pelvic muscle fascia; sensory blockade begins proximally to distally within 10-20 minutes, while motor blockade usually develops later and gradually around 20-30 minutes.

Time frame
1 hour

Secondary outcomes

1

The Numerical Rating Scale (NRS)

Pain control is a one-dimensional measurement tool, usually ranging from 0 to 10, used to subjectively assess a patient's pain intensity. In academic literature, this scale, expressed with integers from 0 (no pain) to 10 (the most severe pain imaginable), is considered a fundamental parameter for pain monitoring in clinical research and perioperative processes due to its high validity, ease of application, and flexibility in verbal or written form.

Time frame
1 Day

Other outcomes

Sponsors and contacts

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