NCT06209372

Brief Summary

We aimed to investigate the effectiveness of the pericapsular nerve group (PENG) block applied with preoperative ultrasonography (USG) in patients who were operated on under spinal anesthesia due to hip fracture and whether it influences spinal anesthesia success. The files of 100 patients were reviewed observationally, and 60 patients were included in the study. The patients were divided into two groups: Group P (n = 30) comprising patients who underwent PENG block under USG guidance before the start of surgery and the control group (Group C; n = 30) of patients in whom tramadol infusion was started. From the files of the patients, the transition from the bed to the operating table, lateral decubitus position, skin incision, postoperative exit, postoperative 2nd, 4th, 12th, and 24th hour numeric rating scale (NRS) values, spinal anesthesia duration and number of attempts, and perioperative total tramadol consumption were recorded. During the transfer from the patient bed to the operating table and during the lateral decubitus position, postoperative exit and postoperative 2nd, 4th, 8th, 12th, and 24th hour NRS values were found to be significantly lower in Group P. In addition, lower spinal anesthesia time, lower number of spinal anesthesia attempts, and lower perioperative total tramadol consumption were detected in Group P. We found that PENG block applied preoperatively to patients with spinal anesthesia decreased the perioperative pain score, increased the success of spinal anesthesia by facilitating positioning for spinal anesthesia, and decreased the need for postoperative opioids.

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 all trials

Timeline
Completed

Started Dec 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

October 5, 2023

Last Update Submit

April 23, 2024

Conditions

Keywords

Fracture, Hip;Block, Pericapsular Nerve Group;Anesthesia, Spinal;Success;Ultrasound

Outcome Measures

Primary Outcomes (2)

  • Change in pain score after applying Pericapsular Nerve Group Block (PENG)

    In line with the literature, we determined that the NRS value significantly decreased during positioning for spinal anesthesia in the group where the PENG block was applied.

    30 minutes after applying PENG block

  • Pericapsular Nerve Group Block (PENG) block facilitates the success of spinal anesthesia

    Effective pain control facilitates the success of spinal anesthesia by making positioning and application easier is supported by our study.

    30 minutes after applying PENG block

Study Arms (2)

Group PENG (P)

Group PENG (P) received the PENG block with 20 mL of 0.25% bupivacaine under ultrasound guidance at preoperative care unit (PCU). The linear ultrasound probe for the PENG block was placed parallel to the imaginary line passing between the spina iliaca anterior inferior and the iliopubic eminence (IPE). The 80mm peripheral block needle was advanced with the in-plane technique, and the block was completed by injecting 20 mL of 0.25% bupivacaine.

Procedure: Group PENG

Group Control (C)

Group Control (C), patients who did not prefer the block were given 10 mg of IV bolus tramadol, followed by 10 mg/hr infusion at preoperative care unit (PCU).

Drug: Group C

Interventions

Group PENGPROCEDURE

Pericapsular Nerve Group Block (PENG)

Group PENG (P)

Tramadol infusion

Group Control (C)

Eligibility Criteria

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

Patients undergoing hip fracture surgery

You may qualify if:

  • Over 18 years old
  • American Society of Anesthesiologists' (ASA) I-II-III

You may not qualify if:

  • Patients with a history of chronic pain,
  • Previous hip joint surgery,
  • Unsuccessful PENG block or spinal anesthesia application,
  • Missing data in their records
  • History of bleeding diathesis
  • Increased intracranial pressure
  • Severe mitral and/or aortic stenosis
  • Allergic to the medications used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University Hospital

Isparta, Centre, 32200, Turkey (Türkiye)

Location

Related Publications (2)

  • Acharya U, Lamsal R. Pericapsular Nerve Group Block: An Excellent Option for Analgesia for Positional Pain in Hip Fractures. Case Rep Anesthesiol. 2020 Mar 12;2020:1830136. doi: 10.1155/2020/1830136. eCollection 2020.

  • Afolayan JM, Areo PO, Adegun PT, Ogundipe KO, Filani AB. Comparison of ease of induction of spinal anaesthesia in sitting with legs parallel on the table versus traditional sitting position. Pan Afr Med J. 2017 Nov 13;28:223. doi: 10.11604/pamj.2017.28.223.6992. eCollection 2017.

MeSH Terms

Conditions

Bites and StingsHip Fractures

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and InjuriesFemoral FracturesFractures, BoneHip InjuriesLeg Injuries

Study Officials

  • Eyyup Ozden

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 5, 2023

First Posted

January 17, 2024

Study Start

December 15, 2021

Primary Completion

April 15, 2022

Study Completion

June 1, 2022

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations