Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06380244 |
| Other study ID # |
1072.6120.136.2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2024 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Jagiellonian University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Due to the increasing number of reports of cancer progression in people undergoing surgery
under general anesthesia using opioids, OFA is believed to have a favorable long-term
prognostic effect, especially in cancer patients. The opioid-free protocol is also used in
postoperative analgesia. It is estimated that up to 75% of surgical patients experience
chronic postoperative pain, which has a particularly negative impact on the quality of life.
The investigators would like to compare pain during the first 48 postoperative hours of
patients undergoing abdominal surgery who would be anesthetized with opioids and without
opioids (patients would be randomly assigned to a group) (1, 2, 6, 12, 24 and 48 h after
operations). A secondary objective will be to measure total oxycodone consumption in the
postoperative period in both groups. Other secondary objectives: assessment of postoperative
nausea and vomiting (PONV).
Description:
All subsequent patients undergoing abdominal surgery will be randomly divided into two
groups: one under completely opioid-free anesthesia (infusion of Ketamine, Lignocaine and
Dexmedetomidine and inhalation of Desflurane) and the other group under combined general
anesthesia (using an infusion of remifentanil intraoperatively). In the postoperative period,
all patients will receive Oxycodone in a PCA pump or in the form of oral tablets [naloxone
(naloxone hydrochloride) + oxycodone (oxycodone hydrochloride)] and co-analgesics in the form
of Paracetamol and Metamizole. Opioid-free general anesthesia is a recognized method used
during anesthesia. It allows participants to effectively control pain, reducing the number of
complications associated with taking large doses of opioid drugs. It should be emphasized
that it is approved for use in routine anesthetic practice, and whether such a technique will
be used in a given patient depends only on the experience, knowledge and preferences of the
anesthesiologist. It is used in everyday anesthetic practice, but there is no conclusive
scientific data confirming its advantage in patients undergoing abdominal surgery, so
currently it depends only on the individual experience, knowledge and preferences of the
anesthesiologist whether such a technique will be used in a given patient.
Mulier et al. proposed an OFA scheme including the supply of dexmedetomidine, ketamine and
lidocaine for the induction of anesthesia, which ensures sedation, analgesia and
sympathomimetic therapy followed by simultaneous maintenance infusion of lidocaine and
dexmedetomidine. The protocol proposed by Mulier et al. is widely used and accepted
worldwide. Initially, it was used in patients undergoing bariatric procedures, and then for
all types of surgical procedures.
In the postoperative period, patients will have their pain level assessed using the NRS scale
1, 2, 6, 12, 24 and 48 hours after the procedure.
