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NCT Number: NCT07594197

Parasacral Ischial Plane Block in Lower Extremity Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa High Specialization Training and Research Hospital

Bursa, Yildirim, 16300, Turkey (Türkiye)

About this study

Sympatholysis resulting from central neuraxial block or general anesthesia in lower extremity surgeries may lead to adverse hemodynamic changes and increased perioperative mortality, particularly in high-risk patients. In such patients, lower extremity procedures can be successfully performed solely under sciatic and femoral nerve blocks. Depending on the surgical indication, the sciatic nerve block may be utilized alone or in combination with a lumbar plexus or femoral nerve block.A novel ultrasound-guided (USG) fascial plane approach targeting the sacral plexus, termed the Parasacral Ischial Plane (PIP) block, has been successfully investigated in a limited number of patients. 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 bone laterally. The piriformis muscle has no attachment to the ischium; instead, it attaches laterally to the greater trochanter. A fascial plane exists between the piriformis muscle and the ischium, which extends directly to the sacral plexus.

Venkataraju et al. stated that during the demonstration of the PIP block, the needle should be directed and positioned toward the posteromedial surface of the ischium. Following bony contact, the injectate was administered, and its spread was observed beneath the piriformis muscle toward the sacral plexus (SP). This method is considered to be technically more straightforward and carries a lower risk profile.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18-80
  • ASA I-III
  • Patients operated on under regional anesthesia
  • Patients who provided written informed consent
  • Patients scheduled for elective lower extremity surgery -

Exclusion criteria

  • 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
  • Chronic pain syndrome (chronic opioid use)
  • Pregnant women
  • Patients who cannot be communicated with
  • Patients requiring emergency surgery -

Treatment and study plan

Parasacral Ischial Plan Block

Procedure

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

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.

Primary outcomes

  1. Sensory and motor block onset time

    Time frame: 1 hour

    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.

Secondary outcomes

  1. The Numerical Rating Scale (NRS)

    Time frame: 1 Day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Korgün Ökmen, professor

CONTACT

[email protected]

+905057081021

NURULLAH DAMLA

CONTACT

[email protected]

+905075482122

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Evaluation of Sensory and Motor Blockade of Ultrasound-Guided Parasacral Ischial Plane Block in Lower Extremity Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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