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RECRUITING
NCT06878014
PHASE4

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

Sponsor: Medical University of Silesia

View on ClinicalTrials.gov

Summary

Pain management after total hip replacement is one of the most important aspects of postoperative care for patients and clinicians alike. One of the most common techniques used in anesthesia for this procedure is spinal anesthesia with concurrent administration of opioids into spinal sac. Addition of opioids not only prolongs the anesthesia but also provides pain relief after the procedure for a limited amount of time. Because of its unique chemical properties morphine provides the longest pain relief amongst currently known opioids lasting up to 24 hours. Unfortunately this beneficial effect is associated with both minor and serious adverse effects, most important of which is respiratory depression. To limit this potenitialy fatal adverse effect dosing of morphine must be very precise in order to balance advantages and risks. The aim of the study was to assess effectiveness and safety profile of different doses of morphine administered during spinal anesthesia for pain control.

Official title: Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-03-04

Completion Date

2026-06-28

Last Updated

2026-02-12

Healthy Volunteers

No

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.

Locations (3)

Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary

Sosnowiec, Silesian Voivodeship, Poland

Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie

Szczecin, West Pomeranian Voivodeship, Poland

Zespół Opieki Zdrowotnej w Końskich

Gmina Końskie, Świętokrzyskie Voivodeship, Poland