## Protocol Section
### Identification Module
**NCT ID:** NCT06429605

**Brief Title:** Evaluating the Efficacy and Safety of Preoperative Administration of Duloxetine for Pain Management in Women Undergoing Vaginal Hysterectomy.

**Official Title:** Evaluating the Efficacy and Safety of Preoperative Administration of Duloxetine for Pain Management in Women Undergoing Vaginal Hysterectomy.

#### Organization Study ID Info
**ID:** Muğla-77
#### Organization
**Class:** OTHER
**Full Name:** Erzincan Military Hospital
### Status Module
#### Completion Date
**Date:** 2025-01-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Erzincan Military Hospital

#### Responsible Party

**Investigator Affiliation:** Erzincan Military Hospital

**Investigator Full Name:** Kemal GUNGORDUK

**Investigator Title:** MD.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Vaginal hysterectomy is the preferred route of choice for women desiring hysterectomy to treat uterine pathology, including premalignant conditions and fibroids. Compared with an abdominal or a laparoscopic approach, VH has been associated with a shorter recovery time and faster return to daily activities. However, management of postoperative pain still remains challenging for patients undergoing VH.

Duloxetine is a serotonin-norepinephrine reuptake inhibitor commonly prescribed for the treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain In contrast, studies examining its use to ameliorate acute postoperative pain are limited to a single trial.12 More importantly, it remains to be determined whether perioperative duloxetine can improve the global quality of recovery after surgery. The study included the hypothesis that perioperative duloxetine would ease postoperative recovery in patients undergoing VH, and the Quality of Recovery-15 questionnaire (QoR-15) was to be used for evaluation

### Conditions Module

**Conditions:**

- Vaginal Hysterectomy

- Postoperative Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Only our clinic's standard preoperative and postoperative care were used (Güngördük K, Selimoğlu B, Gülseren V, Yasar E, Comba C, Özdemir İA. Effect of abdominal hot pack application on gastrointestinal motility recovery after comprehensive gynecologic staging surgery. Int J Gynaecol Obstet. 2024 Mar;164(3):1108-1116)

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** In addition to our standard clinical protocol, study patients were administered 60 mg oral duloxetine 2 hours before surgery and 24 hours after surgery

**Intervention Names:**

- Drug: duloxetine

**Label:** Duloxetine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Duloxetine

**Description:** In addition to our standard clinical protocol, study patients were administered 60 mg oral duloxetine 2 hours before surgery and 24 hours after surgery

**Name:** duloxetine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** the level of abdominal pain during ambulation (according to VAS score) Since the visual analog scale (VAS) has been used in prior studies for evaluating similar outcomes \[10\], a 100-mm VAS was used to grade the level of pain. For assessing pain at rest, patients were asked to grade their level of pain from 0 (no pain) to 10 (worst pain ever experienced) at the abdomen and at the vagina while lying in bed. For assessing pain during ambulation, patients were asked to stand up, walk a few steps, and sit in a chair. Then, they were asked to grade their pain, using the same scale, during ambulation.

**Measure:** The primary outcome

**Time Frame:** 8 hours after surgery

#### Secondary Outcomes

**Description:** The QoR-15 is a 15-item questionnaire that measures the patient's QoR. Each item is answered on an 11-point numerical rating scale. The score ranges from 0 to 150 with a higher score indicating a better QoR. It measures in the domains of pain, physical comfort, physical independence, psychological support, and emotional state

**Measure:** total QoR-15 score.

**Time Frame:** on postoperative day 2

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients undergoing VH with or without bilateral salpingo-oophorectomy to gynecologic conditions and uterine size ≤12 weeks
* American Society of Anesthesiologists grade 1-3

Exclusion Criteria:

* patients with chronic non-gynecologic conditions (liver or renal or pulmonary disease or diabetes) -those using psychiatric drugs (antidepressants, neuroleptics, lithium) in the last 1 year, ---
* those with duloxetine allergy
* those using opioids for gynecologic or non-gynecologic conditions
* additional concurrent abdominal/ laparoscopic procedures
* Total vaginal prolapsus

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drkemalgungorduk@gmail.com

**Name:** Kemal Güngördük

**Phone:** 05057465266

**Role:** CONTACT

## 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

### 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: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000068760

- Term: Serotonin and Noradrenaline Reuptake Inhibitors

- ID: D000014179

- Term: Neurotransmitter Uptake Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000015259

- Term: Dopamine Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M299

- Name: Duloxetine Hydrochloride

- Relevance: HIGH

- As Found: American

- ID: M12575

- Name: Norepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M305

- Name: Serotonin and Noradrenaline Reuptake Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068736

- Term: Duloxetine Hydrochloride

### Misc Info Module

- Version Holder: 2024-05-31
