## Protocol Section
### Identification Module
**NCT ID:** NCT06423456

**Brief Title:** Postoperative Pain Control Following Hysteroscopy

**Official Title:** A New Alternative for Postoperative Pain Control Following Hysteroscopy;Preoperative Intravenous Lidocaine

#### Organization Study ID Info
**ID:** AFSU-OBGYN-BA-01
#### Organization
**Class:** OTHER
**Full Name:** Afyonkarahisar Health Sciences University
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Afyonkarahisar Health Sciences University

#### Responsible Party

**Investigator Affiliation:** Afyonkarahisar Health Sciences University

**Investigator Full Name:** Betül Ahat

**Investigator Title:** Assistant Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**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 Module

**Conditions:**

- Postoperative Pain

- Postoperative Nausea

- Analgesia

**Keywords:**

- hysteroscopy

- intraoperative lidocaine

- postoperative pain

- postoperative nausea

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 160

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: Lidocaine IV

**Label:** Research group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Drug: Saline

**Label:** Control group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Research group

**Description:** 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.

**Name:** Lidocaine IV

**Other Names:**

- lidocaine HCl 2%

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** 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.

**Name:** Saline

**Other Names:**

- 0.09% Saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Visual analog scale (VAS)

**Time Frame:** 24 hours

### Eligibility Module

**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

**Gender Based:** True

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 19 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drbetula@gmail.com

**Name:** Betul Ahat

**Phone:** +905467240341

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Merkez

**Contacts:**

***Contact 1:***

- **Email:** durriza@hotmail.com

- **Name:** Rıza Dur

- **Phone:** +905326919591

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Afyonkarahisar University of Health Science, school of medicine, hospital

**State:** Afyonkarahi̇sar

**Status:** RECRUITING

**Zip:** 06330

#### Overall Officials

**Official 1:**

**Affiliation:** Afyonkarahisar University of Health Science, school of medicine

**Name:** Betul Ahat

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Afyonkarahisar University of Health Science, school of medicine

**Name:** Tuba Berra Sarıtaş

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Afyonkarahisar University of Health Science, school of medicine

**Name:** Rıza Dur

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000014839

- Term: Vomiting

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12273

- Name: Nausea

- Relevance: HIGH

- As Found: Nausea

- ID: M17582

- Name: Vomiting

- Relevance: LOW

- As Found: Unknown

- ID: M22074

- Name: Postoperative Nausea and Vomiting

- Relevance: HIGH

- As Found: Postoperative Nausea

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

- ID: D000009325

- Term: Nausea

- ID: D000020250

- Term: Postoperative Nausea and Vomiting

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000061567

- Term: Voltage-Gated Sodium Channel Blockers

- ID: D000026941

- Term: Sodium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: Analg

- Name: Analgesics

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M11014

- Name: Lidocaine

- Relevance: HIGH

- As Found: Solution

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M23177

- Name: Sodium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M30025

- Name: Diuretics, Potassium Sparing

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008012

- Term: Lidocaine

### Misc Info Module

- Version Holder: 2024-05-31
