Postoperative Pain Control Following Hysteroscopy

NCT ID: NCT06423456

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-02-24

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.

Conditions

Postoperative Pain; Postoperative Nausea; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Research group

During the procedure, intravenous lidocaine of 0.15 ml/kg 1% will be administered intraoperatively before general anesthesia and infusion of lidocaine of 1%(at a dose of 0.2 ml/kg/hour) will be performed during the procedure.

Group Type: ACTIVE_COMPARATOR

Lidocaine IV

Intervention Type: DRUG

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.

Control group

In the control group, 0.9% saline solution will be used instead of lidocaine.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

lidocaine HCl 2%; 0.09% Saline

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Betül Ahat

Assistant Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Betul Ahat

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar University of Health Science, school of medicine

Tuba Berra Sarıtaş

Role: STUDY_CHAIR

Afyonkarahisar University of Health Science, school of medicine

Rıza Dur

Role: STUDY_DIRECTOR

Afyonkarahisar University of Health Science, school of medicine

Locations

Afyonkarahisar University of Health Science, school of medicine, hospital

Merkez, Afyonkarahi̇sar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

AFSU-OBGYN-BA-01

Identifier Type: -

Identifier Source: org_study_id