Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza Univeristy Hospital
Turin, 10126, Italy
Location status: Recruiting
NCT Number: NCT07072286
The goal of this observational clinical trial is to assess the impact of Regional Anesthesia (RA) techniques with the strongest anatomical and scientific support in controlling acute post-operative pain in pelvic/acetabular fractures, as well as their potential role in reducing complications related to excessive intra- and postoperative opioid use.
The main questions it aims to answer are:
Does RA lower opioid use in the first 24 hours after pelvic/acetabular fractures surgery? Does RA lower pain scores in the first 48 hours after surgery, incidence of complications and occurrence of persistent post-surgical pain?
During the hours and days following surgery, the research team will evaluate and assess the intensity of any postoperative pain at predefined time points; quantify the use of pain medications and any related complications; and measure the possible onset of chronic pain and the timeline of functional recovery (through scheduled clinical follow-up at 30, 60, and 90 days).
Participants will:
at the time of surgery, and only in the presence of trained and certified anesthesiologists, patients will receive regional anesthesia techniques in addition to the standard multimodal analgesic treatment. In the absence of certified anesthesiologists, patients will be treated exclusively with systemic multimodal analgesia according to the standard protocol.
All the procedures are part of the current clinical practice and no experimental techniques or medications are involved.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Turin, 10126, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All enrolled subjects will be treated according to the standard analgesic protocol for pelvic fractures, in accordance with available literature and institutional guidelines. Specifically, the protocols include the use of multimodal analgesia techniques in line with current clinical practice, including paracetamol, non-steroidal anti-inflammatory drugs, opioids.
Time frame: Up to 24 hours after surgery
Post-operative opioid consumption (morphine milligram equivalents - MMEs) in the first 24 hours.
Time frame: post-operatively at 6, 12, 24 and 48 hours following surgery
Area under the curve (AUC) of acute pain scores (measured via Numeric Rating Scale - NRS)
Time frame: 30, 60, 90-days after surgery
Incidence of chronic post-operative/post-traumatic pain assessed via Numeric rating scale (NRS) through telephone follow-up.
Time frame: Up to 48 hours after surgery
Incidence of acute side effects related to opioid use (excessive sedation, nausea/vomiting, respiratory depression, pruritus, urinary retention, constipation).
Time frame: Up to 48 hours after surgery
Incidence of complications related to nerve blocks (block failure, nerve damage, hematoma, systemic local anesthetic toxicity).
Time frame: From surgery up to the first follow up at 30 days
Days of admission in the hospital where surgery is provided
Contact information is provided by the study sponsor or research team.
A.O.U. Città della Salute e della Scienza
Other
RELIEVED (REgionaL anesthesIa PElVic fracturEs stuDy) Study. Regional Anesthesia (RA) Techniques for Pain Management in Pelvic Fractures: A Prospective, Monocentric, Pilot Cohort Study. Pain Management in Surgical and Conservative Settings."
Acronym: RELIEVED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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