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NCT Number: NCT06642649

Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia for Opioid Consumption in Laparoscopic Hysterectomy

The aim of the study is to evaluate and compare general anesthesia VS two types of combined anesthesia in opioid consumption after laparoscopic hysterectomy

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ente Ospedaliero Cantonale ORBV, Bellinzona, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General Anesthesia (control group)

Procedure

Only General Anestesia

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

Primary outcomes

  1. PCA morphine consumption in the first 24 and 48 postoperative hours

    Time frame: 48 hours

Secondary outcomes

  1. Number of patients with intraoperative hypotension (MAP e amine)

    Time frame: during surgery

  2. intraoperative opioids consumption

    Time frame: during surgery

  3. postoperative pain scores (VAS) - Visual Analogue Scale - at 4, 12, 24 and 48 hours (from 0 to 10)

    Time frame: 48 hours

  4. postoperative pruritus (rating 1-10)

    Time frame: 48 hours

  5. Number of patientes with postoperative nausea and vomiting

    Time frame: 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

  6. Number of patients with urinary retention

    Time frame: 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.

  7. Quality of Recovery (QoR-15 Score) (0 to 150)

    Time frame: 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Saporito, Anesth

CONTACT

[email protected]

0041 (0)918118978

Roberto Dossi, Anesth

CONTACT

[email protected]

0041 (0)918119341

Sponsors and collaborators

Lead sponsor

Andrea Saporito

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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