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The aim of the study is to evaluate and compare general anesthesia VS two types of combined anesthesia in opioid consumption after laparoscopic hysterectomy
Managing post-operative pain is essential to reduce length of stay, complications, mortality, healthcare costs and the risk of readmission to hospital. At the same time, pain treatment, especially with opiod drugs, could cause side effects and worsen the quality of post-operative hospitalization. Furthermore, intrathecal fentanyl may cause an acute tolerance to opioids, and may worsen postoperative analgesia. In literature, some studies underline how the use of regional anesthesia represents an effective solution in pain control. The goal of this study would be to determine whether post-operative analgesic needs and pain levels are increased by mixing intrathecal fentanyl with spinal anesthesia and intrathecal morphine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study intervention with spinal anesthesia composed by local anesthetic, morphine and no fentanyl | Active Comparator | Every patient will receive, before induction of general anesthesia as in control group, a spinal anesthesia composed by hyperbaric bupivacaine 5 mg 0,5% and morphine sulfate 100 mcg. |
|
| study intervention with spinal anesthesia composed by local anesthetic, morphine and 20 mcg fentanyl | Active Comparator | every patient will receive, before induction of general anesthesia, as in the control group, a spinal anesthesia composed by hyperbaric bupivacaine 5 mg 0,5%, morphine sulfate 100 mcg and fentanyl 20 mcg. |
|
| study intervention NO spinal | Active Comparator | Every patient will receive a general anesthesia induced with propofol (1.5-2.5 mg/kg, individually adjusted), rocuronium (0.6 mg/kg) for muscle relaxation and a continuous infusion of remifentanil (0.05-0.3 mcg/kg/min, depending on the clinical characteristics of the patient). General anesthesia was maintained with a continuous infusion of propofol (4-8 mg/kg/h), and the infusion of remifentanil which was started with the induction. Fractionated doses of rocuronium were administered based on TOF monitoring (train of four) to maintain muscle relaxation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General Anesthesia (control group) | Procedure | Only General Anestesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PCA morphine consumption in the first 24 and 48 postoperative hours | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with intraoperative hypotension (MAP e amine) | during surgery | |
| intraoperative opioids consumption | during surgery | |
| postoperative pain scores (VAS) - Visual Analogue Scale - at 4, 12, 24 and 48 hours (from 0 to 10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Dossi, Anesth | Contact | 0041 (0)918119341 | roberto.dossi@eoc.ch | |
| Andrea Saporito, Anesth | Contact | 0041 (0)918118978 | andrea.saporito@eoc.ch |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Saporito, Anesth | Ente Ospedaliero Cantonale, Bellinzona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ente Ospedaliero Cantonale ORBV | Recruiting | Bellinzona | Switzerland | 6500 | Switzerland | |
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randomized, controlled, prospective, multi-center
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| General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl) |
| Procedure |
General anesthesia + spinal anesthesia with local anesthetic and morfine |
|
| General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl) | Procedure | General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl |
|
| 48 hours |
| postoperative pruritus (rating 1-10) | 48 hours |
| Number of patientes with postoperative nausea and vomiting | At the time of the visit, the patient will be asked if any episodes of nausea or vomiting have occurred (in the concept of a dichotomous variable YES or NO) and if these have required the administration of antiemetic drugs. The number of episodes and the number of requests for drugs in reserve for management will be reported | 48 hours |
| Number of patients with urinary retention | At the time of the visit, once the bladder catheter has been removed after the operation, the patient and the care staff will be asked if any episodes of urinary retention have occurred (in the concept of a dichotomous variable YES or NO) and if further treatment has been necessary. bladder catheterization. | 48 hours |
| Quality of Recovery (QoR-15 Score) (0 to 150) | 48 hours |
| Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli |
| Not yet recruiting |
| Bellinzona |
| Switzerland |
| 6500 |
| Switzerland |
|
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D035061 | Control Groups |
| D000779 | Anesthetics, Local |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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