NCT05444803

Brief Summary

The purpose of the study is to compare the analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 20, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 6, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

March 13, 2023

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

June 20, 2022

Last Update Submit

March 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of pain scores assessed by Numerical rating Score Scale during positioning for spinal anesthesia

    Pain scores will be assessed by Numerical Rating Scale (NRS) scores (from 0=no pain to 10=maximum possible pain).

    30 minutes

Secondary Outcomes (4)

  • Rate of pain scores at rest

    30 min

  • Rate of pain scores on passive limb lifting

    30 min

  • rate of postoperative pain scores

    24 hours

  • Amount of postoperative analgesic consumption

    24 hours

Study Arms (2)

Femoral nerve block group

OTHER

Thirty minutes before the placement of spinal block, patients will be receive a femoral nerve block with Bupivacaine.

Other: femoral nerve block

Peri-capsular nerve group block group

OTHER

Thirty minutes before the placement of spinal block, patients will be receive a peri-capsular nerve group block with Bupivacaine.

Other: peri-capsular nerve group block

Interventions

Patients will be performed a femoral nerve block using bupivacaine thirty minutes before the performing of spinal block.

Femoral nerve block group

Patients will be performed a peri-capsular nerve group block using bupivacaine thirty minutes before the performing of spinal block.

Peri-capsular nerve group block group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with hip fracture scheduled for surgery under spinal anesthesia.

You may not qualify if:

  • hemorrhagic diathesis,
  • peripheral neuropathy,
  • allergy to local anesthetics,
  • mental disorders,
  • use of analgesics for 8 h before the performance of spinal block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaHip Fractures

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Safa Eroglu, M.D.

    Antalya Traning and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

July 6, 2022

Study Start

July 6, 2022

Primary Completion

November 7, 2022

Study Completion

December 19, 2022

Last Updated

March 13, 2023

Record last verified: 2022-06

Locations