NCT07295184

Brief Summary

Postoperative delirium is a significant and commonly encountered complication in patients undergoing hip surgery, particularly among the elderly. Postoperative delirium is associated with serious consequences, including prolonged intensive care unit stay, increased complication rates, higher mortality risk, and rising healthcare costs. The incidence of Postoperative delirium after hip fracture surgery has been reported to range between 13% and 55.9%, indicating a substantial clinical burden. Effective postoperative pain control is critical not only for maintaining quality of life but also for preserving cognitive well-being. In this context, peripheral nerve blocks are frequently used for pain management following hip surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress39%
May 2026Dec 2026

First Submitted

Initial submission to the registry

December 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

May 12, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

December 8, 2025

Last Update Submit

May 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of delirium

    The incidence of delirium will be evaluated in the first 72 hours postoperatively in the intensive care unit.

    72 hours

Interventions

Pericapsular Nerve Group block and the supra-inguinal fascia iliaca block applied

Postoperative analgesia (paracetamol 1000 mg intravenously every 8 hours and celecoxib 200 mg orally every 12 hours)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We conducted a pilot study on 20 patients using the 'goodness-of-fit tests: contingency tables' test with G Power software. In our study, the incidence of rebound pain was 40%, and postoperative delirium developed in 50% of patients with rebound pain, compared to 8.3% in patients without rebound pain. Based on these data, an effect size of 0.356 was found, and an analysis was conducted using α=0.05, 90% power. The sample size was calculated as 83 patients. Considering the dropout rate, a total of 90 patients (36 patients with rebound pain and 54 patients without rebound pain) were calculated to be included in the study.

You may qualify if:

  • Patients aged 18-80
  • ASA I-III risk groups
  • Undergoing elective hip surgery

You may not qualify if:

  • Preoperative history of delirium, dementia, or major neurological disease
  • Present cognitive impairment or severe hearing or visual impairment that could affect pain assessment
  • Development of mechanical ventilation requirement in the intensive care unit; Need for bilateral hip surgery
  • Failure to provide meaningful analgesia after block application due to surgical pain outside the scope of the block
  • Patient's inability to complete the pain diary during postoperative follow-up;
  • Urgent hip surgery
  • Voluntary failure to give consent or request to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42100, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Hasan SENAY, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist, Department of Intensive Care Unit, Konya City Hospital, M.D

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 19, 2025

Study Start

May 12, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations