Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

March 4, 2025

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Analgesics, OpioidAnesthesia, SpinalTotal Hip ReplacementAdverse Anesthesia Outcome
Interventions
PROCEDURE

Spinal Anesthesia (bupivacaine)

Patients were positioned in sitting position on operating table, interspinous space was identified using anatomical landmarks (intercristal line) and palpation. Entire procedure was conducted with aseptic technique, puncture site was prepared with izopropyl alcohol solution. Skin was anesthetized with subcutaneous injection of 1% lidocaine. Spinal puncture was achieved using median or paramedian technique with 27G pencil-point spinal needle. After confirmation of free flow of cerebrospinal fluid 15 mg of 0,5% bupivacaine was administered intrathecaly. Block level was assessed by lack of sensation to alcohol swab in periumbilical area and complete motor block (Bromage 3).

DRUG

Postoperative pain management with acetaminophen

Postoperatively patients received 1,0g of paracetamol every 6 hours,

DEVICE

PCA IV Oxycodone

All patients were equipped with PCA capable syringe pump (Perfusor Space, B. Braun) with 40 milligrams of oxycodone. Care provider explained thoroughly how to operate the device and educated about possible adverse effects.

DRUG

Postoperative pain management with dexketoprofen

Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.

DRUG

Postoperative pain management with metamizole

Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.

DRUG

Preemptive Analgesics

After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.

DEVICE

Patient monitor

Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.

Trial Locations (2)

41-214

Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary, Sosnowiec

26-200

Zespół Opieki Zdrowotnej w Końskich, Gmina Końskie

All Listed Sponsors
lead

Medical University of Silesia

OTHER