Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia

April 16, 2024 updated by: Atef Mohamed Sayed mahmoud, Fayoum University Hospital

Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia: A Prospective, Double-Blinded, Randomized Controlled Trial

Patients undergoing hip hemiarthroplasty can benefit significantly from regional anesthesia in terms of pain management and recovery . There is a wide range of regional anesthetic techniques. The most common in this anatomical region and those with the greatest published research are fascia iliac block, lumbar plexus block, and femoral nerve block . Alternative methods include lateral femoral cutaneous nerve and selective obturator nerve infiltration blocks. Novel techniques, including local infiltration analgesia and quadratus lumborum block, have been reported.

While femoral nerve and lumbar plexus blocks are two common opioid-sparing regional anesthetic procedures that are successful, they come with a risk of undesired lower limb muscle weakness . On the other hand, the fascia iliac block does not always offer sufficient pain relief following hip surgery. The important landmarks targeted on the hip joint branches from the femoral nerve and the auxiliary obturator nerve may now be identified thanks to a recent anatomical study on hip innervation .

This led to the discovery of a novel localized anesthetic treatment termed pericapsular nerve group block (PENG), which blocks these nerves to target the hip's anterior capsule. The PENG block has been suggested as a successful motor-sparing block for hip hemiarthroplasty . The objective of the current study is to evaluate the efficacy of the pericapsular nerve group block (PENG) for the reduction of opioid consumption and management of postoperative pain after hip hemiarthroplasty.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be performed in the Fayoumi University Hospital after approval by the local Institutional Ethics Committee and local institutional review board. The study design will be a double-blinded, randomized controlled study trial. The researcher will inform the participants about the objectives of the study, the examination, and the investigation that will be done. Also, the confidentiality of their information and their right not to participate in the study. Written informed consent will be obtained from all patients included in the study.

The study will include 60 patients who will undergo elective hip hemiarthroplasty. Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block.

Pericapsular Nerve Group (PENG) Block (P group) includes 30 patients who will receive a PENG block.

Control group (C group) includes 30 patients who will not receive a PENG block. A full medical history will be taken from the included patients, including demographic data (age, body mass index , weight, gender), general medical history (Diabetes, Hypertension, medication use), anesthesia, and previous surgeries. The patients' fasting durations will be 8 hours for solids and 2 hours for clear liquids. All patients will be assessed Preoperative for VAS score. All patients were monitored by 5 lead ECG, pulse oximetry, non-invasive blood pressure and an intravenous access will be established.

The technique of spinal anesthesia will be standardized for all patients, an attending anesthesiologist will use a 25-gauge Quincke spinal needle (Spinocan, B. Braun Melsungen AG, Germany) to induce spinal anesthesia in the L3/4 or L4/5 vertebral interspace. Throughout the course of the trial, the attending anesthesiologist will chose the dosages of 0.5% hyperbaric bupivacaine (10 to 15 mg) and fentanyl (15 mcg), aiming for a sensory block at the T4 level. The patient will be placed in the sitting or left lateral position while the spinal injection is given over a period of 15 to 30 seconds. Three minutes following the spinal injection, the sensory block was evaluated with a cold and pinprick test. The patient will be placed in a supine position, neutral-head resting posture in the operating area as standard monitors that mentioned before .

Data will be gathered, coded to make data manipulation easier, double-entered into Microsoft Access, and will be analyzed using SPSS software version 22 running on Windows 7 (SPSS Inc., Chicago, IL, USA). Simple descriptive analysis will use percentages and numbers for qualitative data, arithmetic means for measuring central tendency, and standard deviations for quantifying dispersion for parametric quantitative data.

- For quantitative data: Independent samples t-test will be used to compare quantitative measures between two independent groups Paired t-test will be used to compare two dependent quantitative data.

  • For qualitative data The Chi-square test will be used to compare two of more than two qualitative groups.

  • Sensitivity and specificity test for testing a new test with ROC curve "Receiver Operating Characteristic".

    • The P-value< 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Fayoum Governorate
      • Madīnat Al Fayyūm, Fayoum Governorate, Egypt, 63514
        • Recruiting
        • Fayoum University hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - patients 18 years old or older with ASA physical status 1-3, patients who had no contraindications for spinal anesthesia, and patients undergoing elective surgery.

Exclusion Criteria:

  • Patients with ASA physical status 4 or above.
  • Pre-existing anatomical or neurological deficits in the lower extremity.
  • Intolerance or allergy to local anesthetics.
  • Narcotic dependency.
  • Coagulopathy or using antiplatelet or anticoagulant medications.
  • Neuromuscular diseases.
  • Psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression).
  • Systemic infections or infections at site of injection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pericapsular Nerve Group (PENG) Block (P group)
Patients who will undergo elective hip hemiarthroplasty and receive the Pericapsular Nerve Group (PENG) block postoperatively.
Procedure: Pericapsular Nerve Group (PENG) Block
The PENG block will be performed with the patient in the supine position. A linear high-frequency ultrasound probe (GE LOGIQ/P7 ultrasound, korea/ L6-12RS probe) is initially placed in a transverse plane over the anterior inferior iliac spine (AIIS); the probe is turned slightly medial until the hyperechoic continuous shadow of the iliopubic eminence (IPE). The target will be the plane between the psoas tendon and pubic ramus. The skin puncture site will be anesthetized using lidocaine 2% after skin disinfection and draping. A 22-gauge, 100 mm echogenic needle (Spinocan, B. Braun Melsungen AG, Germany) will be inserted 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, 25 mL of the local anesthetic solution (bupivacaine 0.5%) was injected in 5 mL increments while observing for adequate fluid spread in this plane.
Drug: bupivacaine 0.5% injection
bupivacaine 0.5% injection
Active Comparator: Control group (C group)
Patients who will undergo elective hip hemiarthroplasty without receiving a PENG block.
Procedure: elective hip hemiarthroplasty without receiving a PENG block.
elective hip hemiarthroplasty without receiving a PENG block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid consumption post operative
Time Frame: from zero hour and at time intervals: 30 minutes, 1hour, 3 hour, 6 our., 12 hour, 24 hour, 48 hour, and 36 hour after block administration
total dose of any opioid drug used for pain control postoperative
from zero hour and at time intervals: 30 minutes, 1hour, 3 hour, 6 our., 12 hour, 24 hour, 48 hour, and 36 hour after block administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2) a Visual Analogue Scale (VAS) ranging from zero (no pain) to 10 (severe pain) for dynamic and static pain
Time Frame: at time intervals: 30 minutes, 1hour, 3 hour, 6 hour, 12 hour, 24 hour, 48 hour, and 72 hour. after block administration
Degree of pain as measured by fascial expression with rang from 0 for no pain to 10 for sever pain
at time intervals: 30 minutes, 1hour, 3 hour, 6 hour, 12 hour, 24 hour, 48 hour, and 72 hour. after block administration
3) Time to first opioid use
Time Frame: first 24 hour after block administration
time taken till first dose of opioid drugs to control pain after 24 hour of block administration
first 24 hour after block administration
4) Ability to perform physiotherapy
Time Frame: 1 year
time taken until the participant able to perform physiotherapy in first 24 hour after block administration
1 year
5) Opioid-related side effects.
Time Frame: 1 year
side effects of opioids used for pain control after surgery
1 year
6) Total length stay of hospital
Time Frame: 1 year
time of stay of the participant in the hospital after surgery and block administration
1 year
7) Complications of local anesthetic toxicity
Time Frame: 1 year
complication of local anesthetic drug injected in the procedure
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University Hospital

Investigators

  • Principal Investigator: Atef Mohamed Sayed, MS.C, Faculty of medicine, Fayoum university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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