Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation
Efficacy of Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation: A Randomized Controlled Trial
The goal of this clinical trial is to find out whether a Pericapsular Nerve Group (PENG) block, a type of nerve block used to control pain, can reduce pain after surgery in adults with an acetabular (hip socket) fracture who are undergoing surgical repair. The study will also evaluate the safety of the PENG block.
The main questions this study aims to answer are:
Does a PENG block reduce pain after surgery? Does a PENG block reduce the need for opioid pain medications after surgery? Are there any side effects or complications related to the PENG block? Researchers will compare patients who receive a PENG block with patients who do not receive a PENG block to determine whether the block improves pain control after surgery.
Participants will:
Be randomly assigned to receive either a PENG block or no PENG block before surgery while under general anesthesia.
Undergo surgery to repair their acetabular fracture. Receive the same standard pain medications after surgery. Be asked to rate their pain at several time points after surgery using a standard pain scale.
Have their use of pain medications, recovery, and any side effects recorded during their hospital stay and follow-up.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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San Juan, Puerto Rico, 00935
- Rekrytering
- Puerto Rico Medical Center
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Kontakt:
- Luis Lojo-Sojo, MD
- Telefonnummer: 787773535
- E-post: luis.lojo@upr.edu
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Huvudutredare:
- Luis Lojo Sojo, MD
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Underutredare:
- Norberto J Torres Lugo, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Patient age 18 years or older
- Acetabular Fracture amenable to surgery through the Kocher-Langenbeck approach
- Full weight-bearing capacity prior to the trauma
- Providing written informed consent
Exclusion Criteria:
- Age less than 18 years old
- Fracture pattern not amenable to surgery through Kocher-Langenbeck approach
- Lower extremity fracture ipsilateral to the acetabular fracture
- Any traumatic injury that requires surgical management by other surgical specialty
- Bilateral Acetabular Fractures
- Limited weight bearing capacity prior to the trauma
- Procedure performed under any anesthesia other than GETA
- Chronic opioid use
- History of Substance Abuse
- Allergies or history of adverse reactions to any of the drugs used in the
- Mental Disability
- History of Psychiatric disorders
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: PENG Block Group
This group includes participants who will receive the pericapsular nerve group (PENG) block after surgical intervention.
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PENG Block is a regional block technique well documented in the literature for certain orthopedic injuries and interventions.
However, the efficacy of this intervention on acetabular fracture fixation has not been well studied or addressed in previous literature.
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Inget ingripande: NO PENG Block Group
This group includes participants who will not receive the pericapsular nerve group (PENG) block after surgical intervention and will be considered our control group.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Numeric Pain Rating Scale (NPRS)
Tidsram: From surgery to 48 hours after surgery (12 hour Intervals)
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The NPRS is an 11-point scale scored from 0-10, with " 0 " representing no pain and "10" being the most intense pain experienced.
Patients verbally select a value that is most in line with the intensity of pain that they have experienced at each time point under evaluation.
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From surgery to 48 hours after surgery (12 hour Intervals)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Morphine Miligram Equivalent (MME)
Tidsram: From surgery to 48 hours after surgery (12 hour Intervals)
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MME is the total amount of an opioid drug converted to an equivalent strength of oral morphine.
This measure is used to track the consumption of opioids in a standardized, uniform way.
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From surgery to 48 hours after surgery (12 hour Intervals)
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Time to first opioid dose
Tidsram: From surgery to 48 hours after surgery (Will quantify from surgery to time of administration)
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Will measure in minutes the time that patient spent without consuming opioids before requesting their first rescue therapy (opioid) dose.
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From surgery to 48 hours after surgery (Will quantify from surgery to time of administration)
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Postoperative Complications
Tidsram: From surgery to 48 hours after surgery
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Inpatient complications are unforeseen medical issues that arise during a hospital stay, potentially extending recovery time or requiring additional treatment.
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From surgery to 48 hours after surgery
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Luis Lojo Sojo, MD, University of Puerto Rico
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2406241594
Plan för individuella deltagardata (IPD)
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