Dexamethasone + Intrathecal Morphine in Hip Fractures

NCT07037745 | Completed

• 1 other identifier: KAEK/2024.09.185
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fractures (proximal femur fractures) are a global public health problem with high morbidity and mortality rates, especially in the geriatric population aged 65 years and older. Hip fractures, an important consequence of osteoporosis, occur as a result of low-energy trauma with advancing age. Increased mortality rates are associated with an increased risk of postoperative complications, the need for an intensive care unit, prolonged hospital stay, and decreased quality of life. Multimodal analgesia strategies in geriatric hip fracture patients aim to provide adequate pain control while limiting systemic opioid use. Spinal anesthesia, one of the neuraxial anesthesia methods, is frequently used in this patient group, as it avoids complications associated with general anesthesia. It has been reported that the addition of intrathecal morphine (ITM) to local anesthetics used in minimal-dose spinal anesthesia is practical in postoperative pain control. It has been reported that the use of ITM in the dose range of 0.1-0.2 mg in major orthopedic surgeries such as total hip arthroplasty significantly reduces systemic opioid use and provides a decrease in early pain scores. Nausea, vomiting, and decreased gastrointestinal function in the postoperative period may impair patient comfort. In addition, depending on the dose used, ITM may cause side effects such as postoperative nausea and vomiting (PONV) and pruritus. It has been reported that perioperative use of intravenous dexamethasone reduces postoperative pain scores and the consumed analgesic dose in patients undergoing spinal anesthesia using ITM, as well as reducing PONV. Although the benefit of opioid-sparing analgesia provided by ITM in geriatric hip fracture patients is important, the role of intravenous dexamethasone in effectively controlling side effects such as nausea, vomiting, and pruritus, which may increase with it, is a current and critical area of research. This study aimed to investigate the effect of intravenous (8 mg) dexamethasone added to intrathecal morphine (0.1 mg) on postoperative pain scores, opioid consumption, PONV, and pruritus in geriatric hip fracture patients.

Conditions

Hip Fracture Surgeries

Keywords

postoperative pain; hip fracture; geriatric; spinal morphine; multimodale analgesia

Outcome Measures

Primary Outcomes (1)

• Pain Assessment

  The Visual Analog Scale (VAS) will be used to determine the intensity of pain and to compare the pain felt before and after treatment (2, 6, 12, and 24 hours postoperatively.). VAS is a reliable and easily applicable test used to measure values that cannot be easily measured numerically by converting them into a numerical format. The lowest and highest definitions of the parameters to be evaluated are written on both ends of a 100 mm line. The patient is asked to mark the most appropriate value (location) between these two extreme points. When this scale is used for pain, the numbers "0" are written on one end to indicate no pain, and "10" are written on the other end to indicate the most severe pain, and this is converted into a template, numbers between 0-10 are placed on the line, and the patient is asked to choose the closest number.

  2, 6, 12, and 24 hours postoperatively

Secondary Outcomes (1)

• Paracetamol, diclofenac sodium and tramadol consumption

  First 24 hours postoperatively

Study Arms (2)

Group D

Group that received 0.1 mg intrathecal morphine and 8 mg intravenous dexamethasone

Group C

0.1 mg intrathecal morphine and 8 mg intravenous dexamethasone were not administered in the group, control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Geriatric (age 65 and over) patients with hip fractures

You may qualify if:

• Age 65 and above,
• both genders,
• performing hip fracture surgery under spinal anesthesia using 0.1 mg intrathecal morphine

You may not qualify if:

• Performing another operation with a hip fracture,
• Conversion to general anesthesia after spinal anesthesia,
• Peroperative severe cardiovascular and respiratory failure,
• Systemic steroid use,
• Uncontrolled diabetes,
• Lack of cooperation that makes it difficult to assess the level of pain and -nausea/vomiting in the postoperative period, cognitive impairment

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Istanbul Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Hip Fractures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Kadir Arslan, M.D.

  University of Health Sciences Turkey, Istanbul Kanuni Sultan Suleyman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist physician

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 25, 2025
• Study Start: October 1, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: June 25, 2025

Record last verified: 2024-09

Locations

TU (1)