NCT05358587

Brief Summary

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

April 20, 2022

Last Update Submit

January 4, 2024

Conditions

Pain, AcutePostoperative PainHip Fractures

Outcome Measures

Primary Outcomes (1)

  • Pain scores on the Numeric Rating Scale (NRS)

    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    30 minutes after intervention (PENG block) ]

Secondary Outcomes (5)

  • Duration of spinal anesthesia performance

    up to ten minutes

  • Quality of patient's position

    up to ten minutes

  • analgesic consumption

    24 hours

  • Quality of recovery 15 scale

    24 hours after surgery

  • Quadriceps weakness

    postoperative 6th and 24th hours

Study Arms (2)

PENG (20 mL)

EXPERIMENTAL

In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %)

Other: Ultrasound guided PENG block with 20 mL Local Anesthetic solution

PENG (30 mL)

EXPERIMENTAL

In this group, US guided PENG block will be performed with 30 ml of Bupivacaine solution (0.25 %)

Other: Ultrasound guided PENG block with 30 mL Local Anesthetic solution

Interventions

Ultrasound guided PENG block with 20 mL Local Anesthetic solutionOTHER

In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.

PENG (20 mL)
Ultrasound guided PENG block with 30 mL Local Anesthetic solutionOTHER

In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.

PENG (30 mL)

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for total hip replacement surgery under spinal anesthesia
  • ASA(American Society of Anesthesiology) 1-3
  • Receiving consent that accept regional analgesia

You may not qualify if:

  • contraindications for spinal anesthesia and PENG block
  • impaired cognition or dementia
  • multiple fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, 55040, Turkey (Türkiye)

Location

Related Publications (1)

  • Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.

    PMID: 34873023RESULT

MeSH Terms

Conditions

Acute PainPain, PostoperativeHip Fractures

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Gamze Ertas, specialist

    samsun university, samsun training and research hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiologist

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 3, 2022

Study Start

May 9, 2022

Primary Completion

December 29, 2023

Study Completion

January 4, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

TU(1)