Postoperative Pain Control Following Hysteroscopy

Postoperative Pain Clinical Trial

Official title:

A New Alternative for Postoperative Pain Control Following Hysteroscopy;Preoperative Intravenous Lidocaine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423456
• Other study ID #: AFSU-OBGYN-BA-01
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Afyonkarahisar Health Sciences University
• Contact: Betul Ahat
• Phone: +905467240341
• Email: drbetula[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Nausea
• Pain, Postoperative
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain

Intervention

Drug:
• Lidocaine IV
Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.
• Saline
Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.

Locations

Country	Name	City	State
Turkey	Afyonkarahisar University of Health Science, school of medicine, hospital	Merkez	Afyonkarahi?sar

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS)	After the hysteroscopy procedure is completed, in the postoperative anesthesia care room, postoperative, 30. and 60. in minutes, 4. per hour and 24. pain measurement will be performed for patients per hour using a visual analog scale (VAS) for postoperative pain. In this scale, patients' pain between 0-10 (0=no pain, 10=very severe pain) will be questioned. Dec. The doctor who performed the measurement will not know which drug infusion was made. NSAIDs will be administered to patients with a VAS score > 4. Opioid analgesics will be administered to patients whose pain does not go away. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.	24 hours