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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M50 | Active Comparator | In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly. |
|
| M100 | Active Comparator | In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly. |
|
| M150 | Active Comparator | In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Anesthesia (bupivacaine) | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic efficacy | Analgesic efficacy defined as mean value of NRS (Numerical Rating Scale) at 4, 8, 12 ,24 and 48 hours postoperatively at rest and during rehabilitation/movement. | 48 hours postoperatively |
| Safety profile | Frequency of adverse events including excessive sedation (defined as Richmond Agitation Sedation Score RASS≤-1), constipation, postoperative nausea and vomiting, pruritus and respiratory depression defined as sudden drop in respiration rate by ≥90% for ≥10 seconds or cyanosis. | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction with pain management measured with Likert scale.
| 48 hours postoperatively |
| Length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Szymon Białka, MD PhD | Contact | +48323407593 | szymon.bialka@gmail.com | |
| Jakub Żak, MD | Contact | +48607936667 | jakubzak.sum@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary | Recruiting | Sosnowiec | Silesian Voivodeship | 41-214 | Poland |
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|
| Postoperative pain management with acetaminophen | Drug | Postoperatively patients received 1,0g of paracetamol every 6 hours, |
|
| PCA IV Oxycodone | Device | 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. |
|
| Postoperative pain management with dexketoprofen | Drug | Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours. |
|
| Postoperative pain management with metamizole | Drug | Postoperatively patients received 1,0g of metamizole intravenously every 6 hours. |
|
| Preemptive Analgesics | Drug | After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole. |
|
| Patient monitor | Device | Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours. |
|
Length of stay postoperatively.
| Up to one week. |
| Time to rescue analgesia | Amount of time before first bolus of oxycodone delivered by PCA syringe pump. | 48 hours postoperatively |
| Cumulative dose of oxycodone | Cumulative dose of oxycodone over 48 hours postoperatively. | 48 hours postoperatively |
| Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie | Not yet recruiting | Szczecin | West Pomeranian Voivodeship | 70-204 | Poland |
| Zespół Opieki Zdrowotnej w Końskich | Recruiting | Gmina Końskie | Świętokrzyskie Voivodeship | 26-200 | Poland |
|
| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D002045 | Bupivacaine |
| D000082 | Acetaminophen |
| C118296 | dexketoprofen trometamol |
| D004177 | Dipyrone |
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
| D000632 | Aminopyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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