Postoperative Pain Control Following Hysteroscopy

NCT06423456 | Completed Results

• 1 other identifier: AFSU-OBGYN-BA-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Postoperative Nausea; Analgesia

Keywords

hysteroscopy; intraoperative lidocaine; postoperative pain; postoperative nausea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Research group

ACTIVE COMPARATOR

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.

Drug: Lidocaine IV

Control group

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Lidocaine IV 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.

Also known as: lidocaine HCl 2%

Research group

Saline 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.

Also known as: 0.09% Saline

Control group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar University of Health Science, school of medicine, hospital

Merkez, Afyonkarahi̇sar, 06330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Agnosia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Comprise relatively small cohort size, lack of preoperative VAS score, heterogeneity related with the type of hysteroscopy and operative findings.That the hysteroscopy procedure was not performed by the same surgeon. The inability to measure plasma lidocaine level in this study can be identified. However, since no adverse effects occurred due to IV lidocaine treatment in the postoperative period, it is thought that the toxic dose was not reached in any patient.

Results Point of Contact

• Title: Dr. Betül Ahat
• Organization: afyonkarahisar health sciences university hospital

drbetula@gmail.com

05467240341

Study Officials

• Betul Ahat

  Afyonkarahisar University of Health Science, school of medicine

  PRINCIPAL INVESTIGATOR

• Tuba Berra Sarıtaş

  Afyonkarahisar University of Health Science, school of medicine

  STUDY CHAIR

• Rıza Dur

  Afyonkarahisar University of Health Science, school of medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: March 1, 2024
• Primary Completion: February 23, 2025
• Study Completion: February 24, 2025
• Last Updated: July 23, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)