Clinical trial NCT05920642: Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture
Official title: Risk-benefit Analysis of Intrathecal Morphine Administration to Patients Undergoing Surgical Treatment of Proximal Femoral Fracture (Monocentric, Single-blinded, Randomized Clinical Study Compared to Standard Treatment)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Proximal Femur Fracture
Keywords: proximal femur fracture
morphine administration
pain relief
intrathecal administration
parenteral administration
surgery
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study subjects will be randomized into two parallel groups.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate postoperative pain relief for patients undergoing surgical treatment of proximal femoral fracture using intrathecal administration of morphine.

Detailed description: In this study, the investigators will compare the efficiency of intrathecal morphine administration with the standard of care (parenteral application of analgesics) for pain relief in patients after proximal femoral fracture surgery. The secondary outcome measure will be to determine the frequency of adverse effects of intrathecally administered morphine. The study will be monocentric, randomized, and single-blinded. A total of 50 patients are expected to be enrolled.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* 60 to 90 years of age
* surgical treatment of proximal femur fracture
* The American Society of Anesthesiologists (ASA) classification I to III
* spinal anesthesia used for the operation

Exclusion Criteria:

* general anesthesia used for the operation
* allergy to opioids
* high risk of respiratory depression

Primary outcomes:
measure: Pain assessment
timeFrame: Every 2 hours after the surgery, total of 24 hours
measure: Pain assessment during patient positioning
timeFrame: 24 hours
measure: Time to administration of rescue medication
timeFrame: 24 hours
measure: Total consumption of opioids on Intensive Care Unit
timeFrame: 24 hours
Secondary outcomes:
measure: Hypoventilation - bradypnea
timeFrame: 24 hours
measure: Hypoventilation - presence of hypopnea (TV < 4)
timeFrame: 24 hours
measure: Hypoventilation - SpO2
timeFrame: 24 hours
measure: Hypoventilation - presence of hypoxemia (paO2) (below 10 kPa)
timeFrame: 24 hours
measure: Hypoventilation - other signs of respiratory insufficiency
timeFrame: 24 hours
measure: Hypotension
timeFrame: 24 hours
measure: Bradycardia
timeFrame: 24 hours
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
measure: Effect of antiemetics
timeFrame: 24 hours
measure: Pruritus
timeFrame: 24 hours
measure: Effect of pruritus treatment
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Denis Buršík, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rathmell JP, Pino CA, Taylor R, Patrin T, Viani BA. Intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after hip and knee arthroplasty. Anesth Analg. 2003 Nov;97(5):1452-1457. doi: 10.1213/01.ANE.0000083374.44039.9E.
citation: Yamashita K, Fukusaki M, Ando Y, Tanabe T, Terao Y, Sumikawa K. Postoperative analgesia with minidose intrathecal morphine for bipolar hip prosthesis in extremely elderly patients. J Anesth. 2009;23(4):504-7. doi: 10.1007/s00540-009-0817-5. Epub 2009 Nov 18.
citation: Kwan AS, Lee BB, Brake T. Intrathecal morphine for post-operative analgesia in patients with fractured hips. Hong Kong Med J. 1997 Sep;3(3):250-255.