NCT07075432

Brief Summary

Patients with intertrochanteric femur fractures experience significant perioperative and postoperative pain. Perioperative pain can complicate and prolong the anesthesia process for patients undergoing spinal anesthesia, leading to complications in the procedure. Postoperative pain, in turn, prolongs hospital stays, delays recovery, and can lead to chronic postoperative pain due to high-dose opioid use for pain control. The aim of this single-center, prospective, observational study is to compare the effects of pericapsular nerve block and anterior quadratus lumborum block on spinal anesthesia positioning pain and postoperative analgesia in patients undergoing surgery for intertrochanteric femur fractures. Our study distinguishes itself by providing scientific guidance, as there are no studies in the literature comparing the effects of these two blocks on spinal anesthesia positioning pain, spinal anesthesia success, and postoperative analgesia.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

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 Start

First participant enrolled

May 19, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2025

Completed
Last Updated

November 18, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 11, 2025

Last Update Submit

November 15, 2025

Conditions

Keywords

pericapsular nerve blockquadratus lumborum block, anteriorPain, PostoperativeFracture, intertrochanteric

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale

    The numerical rating scale (NRS) is a pain score used to rate pain. Patients are asked to verbally indicate a number that matches their pain, place a check mark on the number indicating their pain, or point to the number. The scale ranges from 0 to 10. 0 indicates no pain, while 10 represents the worst possible pain.

    24 hours

Study Arms (2)

Grup P-Pericapsular Nerve Block

Among the patients taken to the preoperative preparation room in the operating room, those who received routine ultrasound-guided pericapsular nerve block (PENG) following routine preoperative monitoring will be added to Group P. Pain measurement will be evaluated according to the NRS scale.

Grup Q-Anterior Quadratus Lumborum Block

Among the patients taken to the preoperative preparation room in the operating room, those who underwent routine ultrasound-guided anterior quadratus lumborum (QLB-3) following routine preoperative monitoring will be added to Group Q. Pain measurement will be evaluated according to the NRS scale.

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

It was calculated that a minimum of 64 patients should be included in the study. Patients between the ages of 30 and 85 who are scheduled for intertrochanteric femur fracture surgery by the orthopedics and traumatology clinic will be included in the study.

You may qualify if:

  • Patients scheduled for elective intertrochanteric femur fracture surgery
  • Patients with ASA I, II, or III risk scores
  • Patients aged 30-85

You may not qualify if:

  • Patients with an ASA risk score of IV or higher
  • Patients undergoing emergency surgery
  • Patients who refuse to participate in the study or wish to withdraw afterward
  • Patients with cognitive dysfunction such as Alzheimer's, dementia, or delirium
  • Patients with a history of local anesthetic drug toxicity
  • Patients with an infection in the area where the block will be performed
  • Patients with bleeding diatheses
  • Patients undergoing additional surgery or additional anesthetic procedures (general anesthesia)
  • Patients with a history of chronic opioid use and those receiving neuropathic pain treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Üniversitesi, Erzincan, Merkez 24100

Erzincan, Merkez, 24100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeFemoral FracturesHip Fractures

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFractures, BoneWounds and InjuriesLeg InjuriesHip Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

July 11, 2025

First Posted

July 20, 2025

Study Start

May 19, 2025

Primary Completion

November 19, 2025

Study Completion

November 19, 2025

Last Updated

November 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations