Clinical trial NCT06423456: Postoperative Pain Control Following Hysteroscopy
Official title: A New Alternative for Postoperative Pain Control Following Hysteroscopy;Preoperative Intravenous Lidocaine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Postoperative Nausea
Analgesia
Keywords: hysteroscopy
intraoperative lidocaine
postoperative pain
postoperative nausea
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 160
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intraoperative lidocaine infusion is a frequently preferred method in surgical procedures due to its reducing the need for opioids, providing better postoperative pain control, reducing postoperative nausea and vomiting and increasing rapid recovery. Our aim in this study is to show the effect of intraoperative lidocaine infusion on reducing complications such as pain, nausea, vomiting, and the need for opioid analgesia that occur after hysteroscopy operations, which are often performed in gynecology clinics.
Primary purpose: TREATMENT

Brief summary: Intraoperative lidocaine infusion is a frequently preferred method in surgical procedures due to its reducing the need for opioids, providing better postoperative pain control, reducing postoperative nausea and vomiting and increasing rapid recovery. Our aim in this study is to show the effect of intraoperative lidocaine infusion on reducing complications such as pain, nausea, vomiting, and the need for opioid analgesia that occur after hysteroscopy operations, which are often performed in gynecology clinics.

Detailed description: Hysteroscopy abnormal uterine bleeding, infertility, endometrial pathologies, uterine fibroids,it is a method that is often used in the diagnosis and treatment of pathologies such as intrauterine synechia.

Hysteroscopy; observation of the inner layer of the uterus with a special optical instrument with a cold light source and it is the process of making intrauterine interventions using small hand tools. General anesthesia or with intrauterine fluid after dilating the cervix under regional (epidural/peridural) anesthesia it is filled and a thin telescope-like optical device (hysteroscope) is transmitted into the uterus. This way the uterine cavity is observed. Hysteroscopy is used for diagnostic purposes as well as for therapeutic purposes it can be applied.

General Anesthesia (GA) is often the preferred method for operative hysteroscopy.Intraoperative lidocaine infusion reduces the need for opioids, postoperative pain control is better due to the fact that it reduces postoperative nausea, vomiting and increases rapid recovery, which is often preferred in surgical procedures. 150 patients who are scheduled to undergo hysteroscopy will be included in the study. Hysteroscopy the patients to be applied will be divided into two groups as research and control groups. To both groups 75 patients will be included each. General anesthesia during the procedure for patients in the research arm intravenous lidocaine of 0.15 ml/kg 1% will be administered intraoperatively before and during the procedure a 1% lidocaine infusion(at a dose of 0.2 ml/kg/hour) will be performed. In the control group, if 0.9% saline solution will be used instead of lidocaine.

Pain measurement using visual analog scale (VAS) for postoperative pain after surgery will be done. At the same time, intraoperative analgesic use of patients, postoperative nausea-vomiting and antiemetic uses will be recorded.

Eligibility criteria: Inclusion Criteria:

* Female patients with ASA I-II according to the American Society of Anesthesiologists (ASA) classification who are scheduled for elective hysteroscopy with indications such as
* abnormal uterine bleeding
* endometrial polyp
* submucosal myoma
* foreign body in the endometrial cavity
* infertility
* intrauterine synechia

Exclusion Criteria:

* Patients under the age of 18
* Who are allergic to lidocaine addicted to opioids or NSAIDs
* Patients with chronic pain
* Patients with severe systemic disease
* Patients who do not approve

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Afyonkarahisar University of Health Science, school of medicine, hospital
state: Afyonkarahi̇sar
Study officials:
affiliation: Afyonkarahisar University of Health Science, school of medicine
name: Betul Ahat
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar University of Health Science, school of medicine
name: Tuba Berra Sarıtaş
role: STUDY_CHAIR
affiliation: Afyonkarahisar University of Health Science, school of medicine
name: Rıza Dur
role: STUDY_DIRECTOR
References: