NCT06721052

Brief Summary

The components of the lumbar plexus and capture the articular branches of hip capsule may be effectively blocked by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine. We can provide both the blockade of the pericapsular nerve group supplying the hip capsule and the cutaneous blockade. Here, we aimed to present our novel technique we named 'deep iliacus plane block (DIPB)'.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

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

Study Start

First participant enrolled

February 10, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

December 3, 2024

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain scores (Numerical rating scale-NRS)

    Comparison of NRS before block, after block, and during position for surgery

    Before block, 30 min after block

  • Pain scores (Numerical rating scale-NRS)

    The primary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded

    Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours

Secondary Outcomes (1)

  • Need for rescue analgesia (tramadol)

    Postoperative 24 hours period

Study Arms (1)

Group meta-PENG block

We performed meta-PENG block in patients who underwent hip surgery under spinal or general anesthesia

Drug: meta-Peng blockDrug: Postoperative analgesia management

Interventions

The convex transducer was positioned obliquely in a superolateral to inferomedial direction just above the femoral crest. Anatomical structures including AIIS, iliopubic eminence, sartorius muscle, iliopsoas muscle, psoas tendon, artery, vein, and iliac fascia were identified sono-anatomically. The AIIS was centered in the transducer image. To determine the insertion point of the rectus femoris tendon (RFT) on the AIIS, the transducer was rotated sagittally, and the level where the RFT ends cephalically was identified. After identifying the target, the transducer was obliquated again to visualize the IPE. The 22G x 100 mm block needle was advanced in-plane from lateral to inferomedial towards the potential space between the IPM and AIIS. After confirming the target plane with a few mL of saline, 30-40 mL of 0.25% bupivacain was applied to the area. The spread of injectate was observed beneath the IPM, below the psoas tendon, and around the iliacus muscle within the iliac fascia.

Group meta-PENG block

We ordered 400 mg intravenous ibuprofen for the patients every 8 hours during the postoperative period. We planned to perform 100 mg tramadol as a rescue analgesic if the patient's NRS score was above 4. We observed the patients for 24 hours in the postoperative period.

Group meta-PENG block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent hip fracture surgery due to fracture or another reason

You may qualify if:

  • ASA-1, ASA-2 and ASA-3 patients who underwent hip surgery under spinal or general anesthesia

You may not qualify if:

  • Anticoagulant drug use Known allergy to the medications to be used Infection in the area where the needle will be inserted Missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (4)

  • Pun M, Ng T, Vermeylen K, Tran J. Innervation of the hip joint: implications for regional anaesthesia and image-guided interventional pain procedures. BJA Educ. 2024 Jun;24(6):191-202. doi: 10.1016/j.bjae.2024.02.005. Epub 2024 Apr 8. No abstract available.

    PMID: 38764441BACKGROUND
  • Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomes J, Prats-Galino A, Van de Velde M, Neyrinck A, Sala-Blanch X. The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study. J Anesth. 2018 Dec;32(6):908-913. doi: 10.1007/s00540-018-2558-9. Epub 2018 Sep 24.

    PMID: 30250982BACKGROUND
  • Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

    PMID: 30063657BACKGROUND
  • Nielsen ND, Madsen MN, Ostergaard HK, Bjorn S, Pedersen EM, Nielsen TD, Soballe K, Borglum J, Bendtsen TF. An iliopsoas plane block does not cause motor blockade-A blinded randomized volunteer trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):368-377. doi: 10.1111/aas.13498. Epub 2019 Nov 13.

    PMID: 31650529BACKGROUND

MeSH Terms

Conditions

Hip FracturesHip Injuries

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

February 10, 2024

Primary Completion

September 10, 2024

Study Completion

September 12, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

We will not plan to share IPD

Locations