NCT05788458

Brief Summary

Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain.The anterior hip capsule is innervated by articular branches of femoral nerve, obturator nerve and accessory obturator nerve (AON) as reported by previous anatomic studies, suggesting that these nerves should be the main targets for hip analgesia, which can be blocked by Peri-capsular nerve group (PENG).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_4

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

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

March 15, 2023

Last Update Submit

November 24, 2023

Conditions

Perioperative Pain

Keywords

painpositioningPENG block

Outcome Measures

Primary Outcomes (1)

  • NRS at rest and on passive 15° limb lifting, EOSP.

    From 0 to 10 (0 no pain , 10 very sever pain)

    30 minutes after the block

Secondary Outcomes (3)

  • NRS over 24 hours

    2,4,8,16,24 hours postoperative

  • Amount of morphine intake.

    24 hours postoperative

  • Quality of recovery score (QoR-15)

    at 24 hours postoperative

Study Arms (3)

Group A

ACTIVE COMPARATOR

will receive 20 ml of 0.25 % bupivacaine

Drug: Bupivacain

Group B

ACTIVE COMPARATOR

will receive 20 ml of 0.375 % bupivacaine.

Drug: Bupivacain

Group C

ACTIVE COMPARATOR

will receive 20 ml of 0.5 % bupivacaine.

Drug: Bupivacain

Interventions

BupivacainDRUG

The blocks will be performed in supine position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") will be initially placed in a transverse plane over the anterior superior iliac spine (ASIS) and then alignes to identify the following landmarks: Anterior inferior iliac spine, ilio-pubic eminence, iliopsoas muscle and tendon, the femoral artery, and Pectineus muscle. Point of injection will be musculo-fascial plane between the psoas tendon and ilio-pubic eminence.

Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (ASA )classes I and II
  • patients of either sex
  • above the age of 18 who will undergo hip surgeries( (Dynamic hip screw fixation or hemiarthroplasty)(not older than 2 weeks) with persistent pain and scheduled for surgery under SA with an expected duration of 2.5 hours).

You may not qualify if:

  • patient's refusal to participate
  • any contraindications to SA or peripheral nerve blocks
  • history of ischemic heart disease
  • patients on opioids for chronic pain
  • patients with significant cognitive impairment.
  • Patients who have surgery on the hip or spine within 3 months or have no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

Location

Related Publications (1)

  • Abdelfatah FA, Elhadad MA. Effect of bupivacaine concentration on ultrasound-guided pericapsular group nerve block efficacy in hip surgery patients: comparative, randomized, double-blinded clinical trial. Br J Pain. 2024 Oct;18(5):425-432. doi: 10.1177/20494637241262516. Epub 2024 Jun 14.

    PMID: 39355572DERIVED

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Fatma Ah Abdelfatah, MD

    banha faculity of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

April 1, 2023

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

November 27, 2023

Record last verified: 2023-11

Locations

EG(1)