Acetabular Fractures
Conditions
Keywords
Acetabular Fractures, Pain Management, Pericapsular Nerve Group (PENG), Open Reduction and Internal Fixation (ORIF), Regional Block
Brief summary
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.
Interventions
PROCEDUREPericapsular nerve group (PENG) block
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.
Sponsors
University of Puerto Rico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Prospective Doble-Blinded Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | From surgery to 48 hours after surgery (12 hour Intervals) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Miligram Equivalent (MME) | From surgery to 48 hours after surgery (12 hour Intervals) | 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. |
| Time to first opioid dose | From surgery to 48 hours after surgery (Will quantify from surgery to time of administration) | Will measure in minutes the time that patient spent without consuming opioids before requesting their first rescue therapy (opioid) dose. |
| Postoperative Complications | From surgery to 48 hours after surgery | Inpatient complications are unforeseen medical issues that arise during a hospital stay, potentially extending recovery time or requiring additional treatment. |
Countries
Puerto Rico
Contacts
PRINCIPAL_INVESTIGATORLuis Lojo Sojo, MD
University of Puerto Rico
Outcome results
None listed