Laparoscopic HysterectomyNCT06642649
Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia for Opioid Consumption in Laparoscopic Hysterectomy
A study testing General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl) and General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl) in people with Laparoscopic Hysterectomy and Gynecology, run by Andrea Saporito at 2 sites in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Hysterectomy, Gynecology
- What is being tested?
- General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl) and General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Nov 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 year of age,
- ASA physical status I to III scheduled for laparoscopic hysterectomy (with or without adnexectomy)
Who cannot join
- 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 ,
Show all 10Show fewer
- major oncological surgeries,
- allergy to drugs used in the protocol,
- previous chronic use of analgesics
- history of opioid abuse
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Ente Ospedaliero Cantonale ORBV
Bellinzona, Switzerland, 6500
- Not yet recruiting
Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli
Bellinzona, Switzerland, 6500
Roberto Dossi, Anesth, 0041(0)918119341, roberto.dossi@eoc.ch
About this study
Official title: 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
The aim of the study is to evaluate and compare general anesthesia VS two types of combined anesthesia in opioid consumption after laparoscopic hysterectomy
Read the 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.
- Conditions
- Laparoscopic Hysterectomy, Gynecology
- Being tested
- General Anesthesia (control group), General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl), General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)
- Keywords
- laparoscopic hysterectomy, spinal anesthesia, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anesthesia (control group)Procedure or surgery
Only General Anestesia
General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl)Procedure or surgery
General anesthesia + spinal anesthesia with local anesthetic and morfine
General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)Procedure or surgery
General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl) |
| 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. Receives: Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl) |
| 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. Receives: Procedure: General Anesthesia (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCA morphine consumption in the first 24 and 48 postoperative hours
Measured: 48 hours
Secondary outcomes (7)
Number of patients with intraoperative hypotension (MAP e amine)
Measured: during surgery
intraoperative opioids consumption
Measured: during surgery
postoperative pain scores (VAS) - Visual Analogue Scale - at 4, 12, 24 and 48 hours (from 0 to 10)
Measured: 48 hours
postoperative pruritus (rating 1-10)
Measured: 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
Measured: 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.
Measured: 48 hours
Quality of Recovery (QoR-15 Score) (0 to 150)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, prospective, multi-center
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Saporito
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Saporito, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Andrea Saporito, Anesth, Study chair, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642649
- Sponsor's protocol ID
- LpsSa
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06642649
- Acronym / sponsor ID
- LpsSa
- Conditions
- Laparoscopic Hysterectomy, Gynecology
- Keywords
- laparoscopic hysterectomy, spinal anesthesia, general anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Andrea SaporitoUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized, controlled, prospective, multi-center
| Arm | Type | Receives |
|---|---|---|
| study intervention with spinal anesthesia composed by local anesthetic, morphine and no fentanyl | Active comparator | Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl)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 | Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)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 | Procedure: General Anesthesia (control group)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 18 year of age,
- ASA physical status I to III scheduled for laparoscopic hysterectomy (with or without adnexectomy)
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Anesthesia (control group)Only General Anestesia | Procedure or surgery | study intervention NO spinal |
| General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl)General anesthesia + spinal anesthesia with local anesthetic and morfine | Procedure or surgery | study intervention with spinal anesthesia composed by local anesthetic, morphine and no fentanyl |
| General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl | Procedure or surgery | study intervention with spinal anesthesia composed by local anesthetic, morphine and 20 mcg fentanyl |
Primary outcome
PCA morphine consumption in the first 24 and 48 postoperative hours
Time frame: 48 hours
7 secondary outcomes
Number of patients with intraoperative hypotension (MAP e amine)
Time frame: during surgery
intraoperative opioids consumption
Time frame: during surgery
postoperative pain scores (VAS) - Visual Analogue Scale - at 4, 12, 24 and 48 hours (from 0 to 10)
Time frame: 48 hours
postoperative pruritus (rating 1-10)
Time frame: 48 hours
Number of patientes with postoperative nausea and vomiting
Time frame: 48 hours
Number of patients with urinary retention
Time frame: 48 hours
Quality of Recovery (QoR-15 Score) (0 to 150)
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Saporito, Anesth study chair
Ente Ospedaliero Cantonale, Bellinzona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl) and General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl) in people with Laparoscopic Hysterectomy and Gynecology, run by Andrea Saporito at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Dossi, Anesth (0041 (0)918119341, roberto.dossi@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCA morphine consumption in the first 24 and 48 postoperative hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.