Gynecology, Laparoscopic Hysterectomy
Conditions
Keywords
laparoscopic hysterectomy, spinal anesthesia, general anesthesia
Brief summary
The aim of the study is to evaluate and compare general anesthesia VS two types of combined anesthesia in opioid consumption after laparoscopic hysterectomy
Detailed description
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.
Interventions
PROCEDUREGeneral Anesthesia (control group)
Only General Anestesia
PROCEDUREGeneral Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl)
General anesthesia + spinal anesthesia with local anesthetic and morfine
PROCEDUREGeneral Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)
General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl
Sponsors
Andrea Saporito
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized, controlled, prospective, multi-center
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients over 18 year of age, * ASA physical status I to III scheduled for laparoscopic hysterectomy (with or without adnexectomy)
Exclusion criteria
* patients with inability to consent, * patient refusal, * contraindication to spinal anesthesia (e.g., hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis, coagulopathies or ongoing anticoagulant therapy), * known chronic pain syndrome, known * suspected non- compliance, * drug, or alcohol abuse , * major oncological surgeries, * allergy to drugs used in the protocol, * previous chronic use of analgesics * history of opioid abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCA morphine consumption in the first 24 and 48 postoperative hours | 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 48 hours | — |
| postoperative pruritus (rating 1-10) | 48 hours | — |
| Number of patientes with postoperative nausea and vomiting | 48 hours | 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 |
| Number of patients with urinary retention | 48 hours | 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. |
| Quality of Recovery (QoR-15 Score) (0 to 150) | 48 hours | — |
Countries
Switzerland
Contacts
CONTACTRoberto Dossi, Anesth
CONTACTAndrea Saporito, Anesth
STUDY_CHAIRAndrea Saporito, Anesth
Ente Ospedaliero Cantonale, Bellinzona
Outcome results
None listed