NCT05997940

Brief Summary

The target population of hip surgery is usually the elderly patients with systemic comorbidity. Especially hip fractures are common in society and cause high morbidity and mortality for geriatric patients . Pain felt before and during surgery can cause metabolic and endocrine changes in the body, leading to sleep disorders, depression, delirium, dementia and persistent chronic pain. With effective postoperative analgesia, it is possible to reduce postoperative complications and mortality and accelerate post-surgical recovery. Pharmacological methods such as opioids and NSAIDs used for this may cause further deterioration and other side effects in geriatric patients with reduced renal and hepatic function, thus delaying post-surgical recovery and thus discharge. In order to avoid these side effects, regional anesthesia techniques can be preferred. Regional anesthesia techniques are among the most effective methods of postoperative analgesia. Peripheral nerve blocks are also one of the regional anesthesia methods. Peripheral nerve blocks; They are the most ideal postoperative analgesia methods because they provide effective analgesia, reduce the need for opioids and consequently their side effects, are effective in the treatment of dynamic pain and facilitate recovery. Patients undergoing hip surgery have very severe pain and need additional postoperative analgesics. Mobilization of patients is delayed due to pain . Depending on this , thromboembolism , deep vein The risk of nosocomial infection increases due to thrombosis , wound infection and increased length of stay. Alleviating the pain around the hip joint capsule is an effective analgesia method in hip surgeries. The anterior capsule of the hip joint is innervated by the femoral , obturator , and accessory obturator nerves . Pericapsular nerve group (PENG) block also targets these nerves. Many studies have shown that PENG block provides adequate analgesia for more than 24 hours postoperatively. PENG block is a method that is frequently used in the world and in our clinic and has a low complication rate. In this study, the investigators aimed to show that pericapsular nerve group block performed before spinal anesthesia in hip surgeries reduces postoperative pain and decreases total opioid consumption.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

Study Start

First participant enrolled

October 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

July 11, 2023

Last Update Submit

August 9, 2023

Conditions

Keywords

Pericapsular nerve group (PENG) blockPostoperative analgesiaHip SurgeryRegional anesthesiaSpinal anesthesia

Outcome Measures

Primary Outcomes (7)

  • Numeric Rating Scale (NRS) for postoperative analgesic efficacy

    NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).

    Preoperative

  • Numeric Rating Scale (NRS) for postoperative analgesic efficacy

    NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).

    During the spinal anesthesia

  • Numeric Rating Scale (NRS) for postoperative analgesic efficacy

    NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).

    Postoperative 0. hour

  • Numeric Rating Scale (NRS) for postoperative analgesic efficacy

    NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).

    Postoperative 1. hour

  • Numeric Rating Scale (NRS) for postoperative analgesic efficacy

    NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).

    Postoperative 6. hour

  • Numeric Rating Scale (NRS) for postoperative analgesic efficacy

    NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).

    Postoperative 12. hour

  • Numeric Rating Scale (NRS) for postoperative analgesic efficacy

    NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).

    Postoperative 24. hour

Secondary Outcomes (1)

  • Amounts of postoperative analgesic consumption

    Postoperative 24 hours

Study Arms (2)

PENG

ACTIVE COMPARATOR

PENG block performed before spinal anesthesia

Drug: PENG block

Control

NO INTERVENTION

Interventions

The PENG block was performed with the patient in the supine position at preoperative waiting room. A curvilinear low-frequency ultrasound probe (2-5 MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22 gauge, 100 mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL

PENG

Eligibility Criteria

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

You may qualify if:

  • Patients with written informed consent
  • Patients over 18 years old
  • Patients with ASA score I-II-III
  • Patients performed spinal anesthesia for surgery

You may not qualify if:

  • Patients without written informed consent
  • Patients with ASA score IV and above
  • Patients who cannot be communicated
  • Patients with infection at the block site
  • Patients with coagulation disorders
  • Patients not suitable for spinal anesthesia
  • Patients with liver and kidney failure
  • Patients who are allergic to the drugs used
  • Patients with major complications during the operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Faculty of Medicine

Aydin, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Central Study Contacts

Kadir Berkay TAN, Resident Doctor

CONTACT

Mustafa OGURLU, Professor Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

July 11, 2023

First Posted

August 18, 2023

Study Start

October 1, 2022

Primary Completion

August 15, 2023

Study Completion

September 1, 2023

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations