NCT07078773

Brief Summary

This study aims to determine the efficacy and safety of the Pericapsular Nerve Group (PENG) block in preventing obturator nerve reflex during transurethral resection of bladder tumors.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

July 12, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

July 12, 2025

Last Update Submit

August 7, 2025

Conditions

TURBT

Keywords

Pericapsular Nerve Group (PENG) blockobturator nerve reflex

Outcome Measures

Primary Outcomes (1)

  • the percentage reduction in adductor muscle strength at 5, 10, 15, 20, 25, 30 minutes, and 3 hours after drug administration, compared to pre-administration levels.

    The percentage increase in adductor strength from preoperative to postoperative measurements divided by preoperative adductor strength is larger, reflecting a better nerve block effect and superior obturator nerve reflex inhibition.

    5, 10, 15, 20, 25, 30 minutes, and 3 hours post-administration

Secondary Outcomes (1)

  • Presence of obturator nerve reflex during surgery

    During surgery

Other Outcomes (6)

  • Physician Satisfaction Score

    Up to 48 hours postoperative

  • Incidence of adverse reactions such as local anesthetic toxicity and nerve injury post-administration.

    Up to 48 hours postoperative

  • Surgical Duration

    During surgery

  • +3 more other outcomes

Study Arms (2)

PENG Group:Ultrasound-guided pericapsular nerve group (PENG) block.

EXPERIMENTAL

A convex ultrasound probe (frequency 2-5 MHz) was positioned at the patient's inguinal ligament, with one end directed toward the anterior inferior iliac spine (AIIS), clearly visualizing the bony prominences of the iliopubic eminence and the AIIS. The needle tip was directed medially toward the pectineus muscle. Upon reaching the space between the pectineus muscle and the pubic bone, and after confirming the absence of blood on aspiration, 30 ml of 0.375% ropivacaine was injected.

Procedure: peng block

Control group : Ultrasound-guided obturator nerve block.

ACTIVE COMPARATOR

An ultrasound probe was positioned at the inguinal ligament, with the needle inserted parallel to the long axis of the probe. After confirming no blood upon aspiration, 15 ml of 0.375% ropivacaine was injected into the fascial plane between the adductor brevis and adductor magnus, as well as into the midportion of the adductor longus and adductor brevis muscles.

Procedure: obturator nerve block

Interventions

peng blockPROCEDURE

A convex ultrasound probe (frequency 2-5 MHz) was positioned at the patient's inguinal ligament, with one end directed toward the anterior inferior iliac spine (AIIS), clearly visualizing the bony prominences of the iliopubic eminence and the AIIS. The needle tip was directed medially toward the pectineus muscle. Upon reaching the space between the pectineus muscle and the pubic bone, and after confirming the absence of blood on aspiration, 30 ml of 0.375% ropivacaine was injected.

PENG Group:Ultrasound-guided pericapsular nerve group (PENG) block.
obturator nerve blockPROCEDURE

An ultrasound probe was positioned at the inguinal ligament, with the needle inserted parallel to the long axis of the probe. After confirming no blood upon aspiration, 15 ml of 0.375% ropivacaine was injected into the fascial plane between the adductor brevis and adductor magnus, as well as into the midportion of the adductor longus and adductor brevis muscles.

Control group : Ultrasound-guided obturator nerve block.

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older;
  • Scheduled for TURBT for unilateral bladder tumor;
  • Able to understand and provide informed consent;

You may not qualify if:

  • Patients who refuse or are unable to provide informed consent;
  • Allergic to local anesthetics, insensitive to propofol or general anesthetics;
  • Pregnant women;
  • Severe liver dysfunction;
  • Evidence of infection at or near the proposed puncture site;
  • Any sensory or motor impairment of the lower limbs;
  • Recent (within 6 months) lower limb joint replacement surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (5)

  • Yoshida T, Nakamoto T, Kamibayashi T. Ultrasound-Guided Obturator Nerve Block: A Focused Review on Anatomy and Updated Techniques. Biomed Res Int. 2017;2017:7023750. doi: 10.1155/2017/7023750. Epub 2017 Feb 9.

    PMID: 28280738BACKGROUND

  • Bolat D, Aydogdu O, Tekgul ZT, Polat S, Yonguc T, Bozkurt IH, Sen V, Okur O. Impact of nerve stimulator-guided obturator nerve block on the short-term outcomes and complications of transurethral resection of bladder tumour: A prospective randomized controlled study. Can Urol Assoc J. 2015 Nov-Dec;9(11-12):E780-4. doi: 10.5489/cuaj.3149. Epub 2015 Nov 4.

    PMID: 26600884BACKGROUND

  • Anagnostopoulou S, Kostopanagiotou G, Paraskeuopoulos T, Chantzi C, Lolis E, Saranteas T. Anatomic variations of the obturator nerve in the inguinal region: implications in conventional and ultrasound regional anesthesia techniques. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):33-9. doi: 10.1097/AAP.0b013e3181933b51.

    PMID: 19258986BACKGROUND

  • Turner K, Levi Sandri GB, Boucher E, Henno S, Le Prise E, Meunier B, Boudjema K, Sulpice L. Complete radiological response of an initially locally advanced unresectable pancreatic cancer to chemoradiotherapy using FOLFIRINOX regimen: report of a case. Clin Res Hepatol Gastroenterol. 2015 Apr;39(2):e29-31. doi: 10.1016/j.clinre.2014.08.011. Epub 2014 Oct 3. No abstract available.

    PMID: 25288453BACKGROUND

  • Nielsen TD, Moriggl B, Soballe K, Kolsen-Petersen JA, Borglum J, Bendtsen TF. A Cadaveric Study of Ultrasound-Guided Subpectineal Injectate Spread Around the Obturator Nerve and Its Hip Articular Branches. Reg Anesth Pain Med. 2017 May/Jun;42(3):357-361. doi: 10.1097/AAP.0000000000000587.

    PMID: 28263244BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Liu Han

    Nanjing First Hospital, Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 12, 2025

First Posted

July 22, 2025

Study Start

July 12, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)