NCT07594197

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026May 2027

Study Start

First participant enrolled

May 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 5, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

Lumbosacral PlexusAnesthesia, ConductionPostoperative Pain

Outcome Measures

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.

    1 hour

Secondary Outcomes (1)

  • The Numerical Rating Scale (NRS)

    1 Day

Study Arms (2)

Parasacral Ischial Plan Block

ACTIVE COMPARATOR

A novel ultrasound-guided fascial plane approach to the sacral plexus, called the Parasacral-Ischial Plane (PIP) block, has been successfully studied in a small 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 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 a PIP block demonstration, the needle should be directed and placed towards the posteromedial surface of the ischium. After bone contact, medication was injected, and it was observed that the medication spread from under the piriformis muscle towards the sacral plexus. This method is considered easier and less risky.

Procedure: Parasacral Ischial Plan Block

Sacral plexus block

ACTIVE COMPARATOR

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.

Procedure: Sacral plexus block

Interventions

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.

Parasacral Ischial Plan Block

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.

Sacral plexus block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa High Specialization Training and Research Hospital

Bursa, Yildirim, 16300, Turkey (Türkiye)

Location

Related Publications (6)

  • Enneking FK, Chan V, Greger J, Hadzic A, Lang SA, Horlocker TT. Lower-extremity peripheral nerve blockade: essentials of our current understanding. Reg Anesth Pain Med. 2005 Jan-Feb;30(1):4-35. doi: 10.1016/j.rapm.2004.10.002. No abstract available.

    PMID: 15690265BACKGROUND
  • Zhao J, Huang Y, Fu M, Tao F. Ultrasound-guided suprainguinal fascia iliaca block combined with a sacral plexus block for lower extremity surgery: A case report. Medicine (Baltimore). 2020 Aug 28;99(35):e21921. doi: 10.1097/MD.0000000000021921.

    PMID: 32871928BACKGROUND
  • Arjun BK, Prijith RS, Sreeraghu GM, Narendrababu MC. Ultrasound-guided popliteal sciatic and adductor canal block for below-knee surgeries in high-risk patients. Indian J Anaesth. 2019 Aug;63(8):635-639. doi: 10.4103/ija.IJA_296_19.

    PMID: 31462809BACKGROUND
  • Chia N, Low TC, Poon KH. Peripheral nerve blocks for lower limb surgery--a choice anaesthetic technique for patients with a recent myocardial infarction? Singapore Med J. 2002 Nov;43(11):583-6.

    PMID: 12680529BACKGROUND
  • Bech B, Melchiors J, Borglum J, Jensen K. The successful use of peripheral nerve blocks for femoral amputation. Acta Anaesthesiol Scand. 2009 Feb;53(2):257-60. doi: 10.1111/j.1399-6576.2008.01859.x.

    PMID: 19175579BACKGROUND
  • Venkataraju A, Narayanan M, Phillips S. Parasacral ischial plane (PIP) block: An easy approach to sacral plexus. J Clin Anesth. 2020 Feb;59:103-105. doi: 10.1016/j.jclinane.2019.06.030. Epub 2019 Jul 16. No abstract available.

    PMID: 31323463BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Korgün Ökmen

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Korgün Ökmen, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Comparison of methods between 2 groups.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSISTANT

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 18, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

due to patient privacy

Locations