Comparing anesthesia methods to reduce opioid use after laparoscopic hysterectomy
Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia (general and Spinal Anesthesia) for Opioid Consumption in Laparoscopic Hysterectomy: a Multi-Center, Randomized, Prospective, Controlled Trial
This study is testing whether different anesthesia methods can help women who have laparoscopic hysterectomy use fewer opioids for pain relief after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 2 sites (Bellinzona, Switzerland and 1 other locations) |
| Trial ID | NCT06642649 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of general anesthesia versus two types of combined anesthesia in managing opioid consumption following laparoscopic hysterectomy. It aims to determine whether mixing intrathecal fentanyl with spinal anesthesia and intrathecal morphine affects post-operative pain levels and analgesic needs. The study addresses the importance of effective pain management to minimize complications, healthcare costs, and the risk of readmission. By comparing these anesthesia methods, the research seeks to identify the best approach for reducing opioid-related side effects and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with ASA physical status I to III scheduled for laparoscopic hysterectomy.
Not a fit: Patients with contraindications to spinal anesthesia, chronic pain syndromes, or a history of opioid abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that reduce opioid consumption and enhance recovery after laparoscopic hysterectomy.
How similar studies have performed: Previous studies have indicated that regional anesthesia can effectively manage post-operative pain, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bellinzona, Switzerland and 1 other locations
- Ente Ospedaliero Cantonale ORBV — Bellinzona, Switzerland, Switzerland (Recruiting)
- Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli — Bellinzona, Switzerland, Switzerland (Not_yet_recruiting)
Study contacts
- Study coordinator: Roberto Dossi, Anesth
- Email: roberto.dossi@eoc.ch
- Phone: 0041 (0)918119341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.