Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-04

Study Completion Date

2025-07-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Proximal Femur Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study subjects will be randomized into two parallel groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The participant will not know which arm of the study he/she has been enrolled into.

Study Groups

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Intrathecal morphine administration

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

Group Type EXPERIMENTAL

Intrathecal morphine administration

Intervention Type DRUG

Administration of morphine into the spinal canal.

Parenteral administration of analgesics

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

Group Type ACTIVE_COMPARATOR

Parenteral administration of analgesics

Intervention Type DRUG

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

Interventions

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Intrathecal morphine administration

Administration of morphine into the spinal canal.

Intervention Type DRUG

Parenteral administration of analgesics

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

Intervention Type DRUG

Eligibility Criteria

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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