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The aim of this study was to compare the effects of two different doses of intrathecal morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative block regression times, postoperative analgesia and the severity of side effects, for inguinal hernia repairs.
The purpose of this study was to compare spinal anesthesia with low dose heavy bupivacaine combined with 0.1 mg or 0.4 mg of morphine in inguinal hernia repair surgeries. Anesthesia onset time (sensory and motor blocks) as well as postoperative recovery (first mobilisation, first voiding) time were compared. Also the postoperative pain management and side effects (nausea, vomiting and pruritus) were assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intrathecal morphine 0.1 mg | Active Comparator | After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive a spinal anaesthesia with 0.1 mg morphine combined with 7.5 mg heavy bupivacaine |
|
| 0.4 mg of intrathecal morphine | Active Comparator | After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive spinal anesthesia with 0.4 mg of morphine combined with 7.5 mg of heavy bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg | Drug |
| ||
| intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory and motor block | Sensory and motor block produced by the spinal anaesthesia will be assessed prior the procedure to define readiness for surgery and then once the procedure is over, sensory and motor block levels will be assessed one more time to follow up the block regression times. Motor block will be assessed with Bromage scale (0: no motor block, 1: hip blocked; 2: hip and knee blocked; 3: hip, knee and ankle blocked). Sensory block will be assessed using loss of pinprick sensation. The onset of surgical anesthesia is defined as loss of pinprick sensation at ≥ T10 with a Bromage score ≥ 2. | The change in motor block and sensory block levels will be assessed after performing spinal block, every 5 minutes for 30 minutes and then at the end of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| first mobilisation, first urination and first analgesic times | all patients will be followed up during the first postoperative 24 hours to assess the first mobilisation, first voiding and first analgesic requirement times. | after the procedure, during the first 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative nausea, vomiting and pruritus | All patients will be followed up for the first postoperative 24 hours to determine the nausea, vomiting and pruritus incidences. | after the procedure, during the first 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Basak Ceyda Meco | Ankara University Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Faculty of Medicine, Ibni Sina Hospital general surgery OR | Ankara | 06700 | Turkey (Türkiye) |
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| Drug |
|
| standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland | Device | electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure |
|
| intravenous cannulation and premedication | Drug | 18-gauge intravenous cannula was inserted at the forearm opposite to the surgical side and routine iv premedication (midazolam 0.03 mg/kg) was given |
|
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D009325 | Nausea |
| D014839 | Vomiting |
| D011537 | Pruritus |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D011292 | Premedication |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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