Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture

University Hospital Ostrava

Status and phase: Completed; Phase 4

Conditions: Proximal Femur Fracture

Treatments: Drug: Parenteral administration of analgesics; Drug: Intrathecal morphine administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05920642

2021-002765-17 (EudraCT Number)

FNO-KARIM2021-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Intrathecal morphine administration

Experimental group

Description:

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

Treatment:

Drug: Intrathecal morphine administration

Parenteral administration of analgesics

Active Comparator group

Description:

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

Treatment:

Drug: Parenteral administration of analgesics