NCT05652075

Brief Summary

Regional anesthesia for postoperative analgesia in THA includes epidural anesthesia and peripheral nerve blocks. However epidural anesthesia has a great role in THA, it has become restricted as perioperative antithrombotic drugs are generally used for orthopedic patients. the study aim to evaluate and compare efficacy and safety of pericapsular nerve group block (PENG) block and lateral femoral cutaneous nerve versus Lumbar plexus block on postoperative analgesia in hip surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

December 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

December 7, 2022

Last Update Submit

October 18, 2023

Conditions

Keywords

PENGlumber plexuship surgery

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale pain scores

    pain score from 0-10 which 0 mean no pain and 10 the worst pain

    24 hour

Secondary Outcomes (3)

  • first analgesic request

    24 hour

  • total analgesic consumption

    24 hour

  • First time to ambulate

    24 hours

Study Arms (2)

PENG and LFCN

EXPERIMENTAL
Procedure: pericapsular nerve group and lateral femoral cutaneous nerve block

lumbar plexus

EXPERIMENTAL
Procedure: lumbar plexus block

Interventions

Will undergo pericapsular nerve group block (PENG) combined with lateral femoral cutaneous nerve under ultrasound guided block with 20 mL of 0.25% bupivacaine.

PENG and LFCN

Will undergo Lumbar plexus block (LPB) under ultrasound guided block with 20 mL of 0.25 % bupivacaine.

lumbar plexus

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (ASA) physical status I to III scheduled for hip surgery aged (30-70) years

You may not qualify if:

  • Drug allergy,
  • Morbid obesity (BMI \>40 kg/m2),
  • Coagulopathy,
  • Psychiatric disorder,
  • Opioid dependence,
  • Patient refusal to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Minya Governorate, 61511, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • hassan m. hetta, lecturer

    Minia University, faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hassan m. hetta, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and ICU

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 15, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations