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Comparison Between Pericapsular Nerve Group Block (PENG) and Morphine Infusion

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ClinicalTrials.gov Identifier: NCT05023473
Recruitment Status : Completed
First Posted : August 26, 2021
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Abdelrhman Alshawadfy, Suez Canal University

Brief Summary:

The pericapsular nerve group block (PENG) is a regional anaesthetic technique that was developed in 2018, primarily for total hip arthroplasties (THA) as a postoperative analgesia modality with motor sparing benefits.

The block is thought to provide more complete analgesia to the hip by depositing local anaesthetic within the myofascial plane of the psoas muscle and superior pubic ramus.

In this study, the investigators will assess the effect of pericapsular nerve group (PENG) block on pain control in patients with proximal femur fracture in the emergency department.

The Control group will receive morphine as regular patient control analgesia (PCA) The interventional group will receive PENG block before being attached to regular morphine PCA


Condition or disease Intervention/treatment Phase
Analgesia Femur Fracture Procedure: Pericapsular nerve group block Drug: Morphine Sulfate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison Between Pericapsular Nerve Group Block (Peng) and Morphine Infusion in Reducing the Pain of Proximal Femur Fracture in the Emergency Department, a Randomized Controlled Study
Actual Study Start Date : April 1, 2022
Actual Primary Completion Date : August 15, 2022
Actual Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PENG block+ morhine
the participants will receive PENG block before being attached to morphine PCA
Procedure: Pericapsular nerve group block
patients will receive pericapsular nerve group block

Drug: Morphine Sulfate
morphine will be given to both groups as patient-controlled analgesia PCA

Active Comparator: MORPHINE
The participants will be given morphine PCA without PENG block
Drug: Morphine Sulfate
morphine will be given to both groups as patient-controlled analgesia PCA




Primary Outcome Measures :
  1. morphine consumption [ Time Frame: immediately at the end of 24 hours ]
    compare the total morphine consumption in milligrams that is given by patient-controlled analgesia device (PCA)


Secondary Outcome Measures :
  1. Numeric rating scale (NRS) [ Time Frame: immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest ]
    A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable

  2. Incidence of nausea and vomiting [ Time Frame: immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest ]
    desire to vomit or actual vomiting as prescribed yeas or no



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients are aged 18-70 years.
  • Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status grade II) = (patients with mild systemic disease and no functional limitations).
  • Patients having post-traumatic pain associated with fractures of the proximal femur or femoral head.

Exclusion Criteria:

  • Patient refusal to participate in the study
  • Known allergy to LA.
  • Body mass index (BMI) more than 40 kg/m2
  • Heart block greater than first degree
  • Renal, and hepatic dysfunction
  • Underlying coagulopathies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023473


Locations
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Egypt
Suez Canal University
Ismailia, Egypt, 41511
Sponsors and Collaborators
Suez Canal University
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Responsible Party: Abdelrhman Alshawadfy, Lecturer of anesthesia and intensive care, Suez Canal University
ClinicalTrials.gov Identifier: NCT05023473    
Other Study ID Numbers: PENG block
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents