NCT06672289

Brief Summary

Suprainguinal Fascia iliac compartment outlet and Pericapsular nerve reduction, which is a routinely successful method for postoperative analgesia in anesthesia practice; the aim is to investigate information regarding postoperative pain level, analgesic consumption, patient satisfaction and discharge time after arm arthroscopy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Nov 2024

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 Progress74%
Nov 2024Nov 2026

First Submitted

Initial submission to the registry

November 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

November 4, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

November 1, 2024

Last Update Submit

November 1, 2024

Conditions

Keywords

hip arthroscopyPENG blockSuprainguinal Fascia Iliaca Block

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Score

    A Visual Analogue Scale (VAS) is one of the pain rating scales. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient's perspective, this spectrum appears continuous; their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest the VAS score for grading of pain consists of a 10 centimetres (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain

    2-3 hours after surgery

Study Arms (2)

Pericapsular Nerve Block (PENG)

Patients will be monitored with routine monitoring under operating room conditions. After the patient's baseline VAS score and vital signs are recorded, patients will be intubated after induction of general anesthesia. After the site is cleaned, pericapsular nerve block (PENG) will be applied under USG guidance. After the procedure, the patient will be transferred to the surgical team for positioning. Blood pressure and pulse values will be recorded after the procedure and at the 30th minute of surgery. After the patients wake up, another anesthesiologist in the recovery unit will rate the pain of patients in both groups on a scale of 0-10, using the Visual Analogue Scale (VAS) to describe their pain intensity. Heart rates and noninvasive blood pressures of patients taken to the recovery unit will be measured and recorded.

Suprainguinal Fascia Iliaca Block (SFIB)

Patients will be monitored with routine monitoring under operating room conditions. After the patient's baseline VAS score and vital signs are recorded, patients will be intubated after induction of general anesthesia. After the site is cleaned, suprainguinal fascia iliaca block (SFIB) will be applied under USG guidance. After the procedure, the patient will be transferred to the surgical team for positioning. Blood pressure and pulse values will be recorded after the procedure and at the 30th minute of surgery. After the patients wake up, another anesthesiologist in the recovery unit will rate the pain of patients in both groups on a scale of 0-10, using the Visual Analogue Scale (VAS) to describe their pain intensity. Heart rates and noninvasive blood pressures of patients taken to the recovery unit will be measured and recorded.

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll genders will be included this study
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over the age of 18 and under the age of 65 who will undergo hip arthroscopy

You may qualify if:

  • Patients over the age of 18 and under the age of 65 who will undergo hip arthroscopy
  • ASA I-II group patients
  • Patients without allergies
  • Patients without psychiatric disorders
  • Patients without opioid addiction
  • Patients who have the ability to use the patient-controlled analgesia (PCA) device and perform VAS scoring
  • Patients with no contraindications for peripheral blocks

You may not qualify if:

  • Patients who do not want to participate in the study
  • Patients with uncontrolled hypertension
  • Patients with chronic pain or receiving pain treatment,
  • Significant Cardiac Disorder (Coronary Artery Disease, Arrhythmia, Electrocardiography Anomaly, Heart Failure, etc.)
  • Patients with Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Recep AKSU MD Recep AKSU, MD, Professor

CONTACT

Yunus Emre VURAL Dr Dr. Yunus Emre VURAL, Research assistant

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Recep AKSU

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 4, 2024

Study Start

November 15, 2024

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

November 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share