Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture

NCT05920642 | Completed Phase 4

• 2 other identifiers: FNO-KARIM2021-12021-002765-17
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Femur Fracture

Keywords

proximal femur fracture; morphine administration; pain relief; intrathecal administration; parenteral administration; surgery

Outcome Measures

Primary Outcomes (4)

• Pain assessment

  Pain intensity will be assessed using the Visual Analogue Scale (VAS10) scale (0-10). The total value of all measured values will be calculated. The maximum value observed during the 24 hours will be also recorded.

  Every 2 hours after the surgery, total of 24 hours

• Pain assessment during patient positioning

  Pain intensity will be assessed using the VAS10 scale (0-10) during the positioning of the patient.

  24 hours

• Time to administration of rescue medication

  The time to administration of rescue medication (analgesics) will be observed in hours.

  24 hours

• Total consumption of opioids on Intensive Care Unit

  The total consumption of opioids on Intensive Care Unit will be measured in the number of administered doses.

  24 hours

Secondary Outcomes (11)

• Hypoventilation - bradypnea

  24 hours

• Hypoventilation - presence of hypopnea (TV < 4)

  24 hours

• Hypoventilation - SpO2

  24 hours

• Hypoventilation - presence of hypoxemia (paO2) (below 10 kPa)

  24 hours

• Hypoventilation - other signs of respiratory insufficiency

  24 hours

Study Arms (2)

Intrathecal morphine administration

EXPERIMENTAL

Study subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug.

Drug: Intrathecal morphine administration

Parenteral administration of analgesics

ACTIVE COMPARATOR

Study subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics).

Drug: Parenteral administration of analgesics

Interventions

Intrathecal morphine administration DRUG

Administration of morphine into the spinal canal.

Intrathecal morphine administration

Parenteral administration of analgesics DRUG

Standard postoperative pain management of analgesics using parenteral route of administration.

Parenteral administration of analgesics

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (3)

• 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.

  PMID: 14570664 BACKGROUND

• 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.

  PMID: 19921358 BACKGROUND

• 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.

  PMID: 11847368 BACKGROUND

MeSH Terms

Conditions

Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Denis Buršík, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will not know which arm of the study he/she has been enrolled into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be randomized into two parallel groups.

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 27, 2023
• Study Start: September 4, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)