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Pain, PostoperativeNCT04984109

Ultrasound-guided PENG Block in Total Hip Replacement

A study testing Real PENG block in people with Pain, Postoperative and Opioid Overdose, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled study will be carried out on 60 adult patients undergoing primary total hip replacement in Tanta University Hospitals. All Patients will receive spinal anesthesia with either sham or real US-guided PENG block. The primary outcome will be the time to first request for rescue analgesia. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Pain, Postoperative, Opioid Overdose
What is being tested?
Real PENG block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
71 participants
Where
1 siteEgypt
Study dates
2 Aug 2021to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients, aged 21-75 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled to undergo unilateral total hip replacement surgery.

Who cannot join

  • Patient refusal.
  • Known hypersensitivity to local anesthetics.
  • Body mass index > 35 kg /m2.
  • Uncooperative or psychiatric patients.
  • Infection at the injection site.
  • Coagulation disorder.
  • Major cardiac, renal, or hepatic diseases

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University

    Tanta, Algharbia, 31511

Other trials in Egypt

About this study

Official title: The Effect of Preoperative Ultrasound-guided Pericapsular Nerve Group Block (PENG) on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study

  • This randomized controlled study will be carried out on 60 adult patients undergoing primary total hip replacement in Tanta University Hospitals. All Patients will receive spinal anesthesia with either sham or real US-guided PENG block.
  • The primary outcome will be the time to first request for rescue analgesia. The secondary outcome will be the postoperative Numeric Rating Scale (NRS) score and the total morphine consumption (rescue analgesia) in the first 24 h postoperatively.
Read the detailed description
  • This prospective randomized double-blinded study will be carried out on 60 adult patients admitted to Tanta University Hospitals for 6 months started immediately after approval of the Institutional Ethical Committee.
  • A written informed consent will be obtained from each patient. All data of patients will be confidential with secret codes and private files for each patient, all given data will be used for scientific purposes only after an explanation of the purpose of the study to all patients. - Any unexpected risks encountered during the course of the research will be cleared to the patients as well as to the ethical committee on time.
  • The primary endpoint is a prolongation of the postoperative analgesia and reduction of the postoperative analgesic consumption. The study will be terminated if local anesthetic toxicity occurs and this will be announced to the participants and to the ethical committee at the time and adequate measures will be taken to resolve and avoid these risks.
  • Group allocation will be done by using computer-generated software of randomization introduced into sealed opaque envelope technique. A blinded nurse, who does not participate in the study or data collection, will read the number contained in the envelope and make group assignments. All the nerve blocks will be performed by one anesthesiologist.
  • Control Group: (30 patients) will receive sham PENG (just 1mL saline)
  • PENG Group: (30 patients) will receive real PENG (20mL of bupivacaine 0.25% plus 0.2mg/ml dexamethasone)

Anesthetic technique:

•Preoperative assessment will be done by: History taking. Clinical examination. Laboratory investigations including complete blood count, bleeding and clotting times, APTT, liver and kidney function tests.

During the pre-anesthetic assessment, all patients will be familiarized with the Numeric Rating Scale (NRS) score.

  • In the holding area, After the establishment of intravascular access by introducing an 18-gauge intravenous (IV) cannula, all the patients will be preloaded with Ringer's lactate solution (7 mL/kg).
  • On arrival at operation room, Routine monitoring of heart rate by ECG, noninvasive blood pressure (NIBP), pulse oximetry will be done.
  • Lumbar puncture will be performed at the level of L3-L4/L4-L5 intervertebral space with a 25-gauge spinal needle. After ensuring free flow of cerebrospinal fluid, 2 mL of hyperbaric bupivacaine solution (0.5%) (10mg)) with 0.5 mL (25 µg) fentanyl will be injected. The sensory block will be assessed by loss of sensation to pinprick test. The level of the sensory block should achieve at least a level of T10. Moreover, the motor block will be assessed by modified Bromage score till reaching at least a score of 2. (0; means the ability of the patient to move the hip, knee, and ankle, 1; means the inability of the patient to move the hip, but can move the knee and ankle, 2; means the inability of the patient to move the hip and knee, but can move the ankle, and finally 3; means the inability of the patient to move the hip, knee, and ankle). If the sensory and motor block levels will not be achieved within 20 minutes, the patient will be excluded from the study and receive general anesthesia. If the sensory and motor block will be achieved, the patient will receive an ultrasound-guided PENG block before starting the surgery.
  • ThePENG block will be performed with the patient in the supine position in the operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in the transverse plane, and then will be moved caudally to identify the anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of the psoas tendon by hydrolocation, the patients in the PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/ml dexamethasone that will be injected in 5 ml aliquots after negative aspiration.The control group will receive 1 mL of normal saline.
  • After completion of the surgical procedure, a patient will be transferred to Post-Anesthesia Care Unit (PACU). Paracetamol 15 mg/kg IV will be administered every 6 hours after discharge to the ward.
Being tested
Sham PENG block, Real PENG block
Keywords
Hip arthroplasty, Pericapsular nerve block, Pain
Medical subject headings
Pain, Postoperative, Opiate Overdose, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sham PENG blockProcedure or surgery

    The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 1 mL of normal saline.

  • Real PENG blockProcedure or surgery

    The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/mL dexamethasone that will be injected in 5 ml aliquots after negative aspiration.

Study groups in NCT04984109
Study groupRoleWhat they receive
Control groupSham comparatorPatients will receive preoperative US-guided will receive sham PENG with an injection of just 1mL saline.
Receives: Procedure: Sham PENG block
PENG GroupExperimentalPatients will receive preoperative US-guided will receive real PENG with an injection of 20mL of bupivacaine 0.25%+ 0.2mg/mL dexamethasone.
Receives: Procedure: Real PENG block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time for first request of rescue analgesia

    Time to the first call for morphine rescue analgesia.

    Measured: The first day after surgery

Secondary outcomes (1)
  1. Postoperative morphine consumption

    Total morphine consumption (rescue analgesia) in the first day postoperatively.

    Measured: The first day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start2 Aug 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04984109
Sponsor's protocol ID
34582/3/21
Status last verified
Jun 2022
First submitted
24 Jul 2021
Last updated
5 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Once the study had been successfully completed, the data will be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Real PENG block in people with Pain, Postoperative and Opioid Overdose, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time for first request of rescue analgesia (time frame: The first day after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.

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