## Protocol Section
### Identification Module
**NCT ID:** NCT06434233

**Brief Title:** Opioid Use After Laparoscopic Salpingectomy

**Official Title:** A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy

#### Organization Study ID Info
**ID:** IRB00308549
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

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

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-25

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids.

The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.

### Conditions Module

**Conditions:**

- Opioid Use

- Post-operative Pain

- Sterility, Female

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge.

These medications include:

Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets

All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter

**Intervention Names:**

- Drug: Acetaminophen

- Drug: Ibuprofen

- Drug: Oxycodone

**Label:** Arm 1 - Opioid Post-Op Pain Regimen

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients randomized to Arm 2 will not receive an opioid prescription after minimally invasive tubal sterilization procedures at discharge. They will receive only Tylenol and Ibuprofen as follows:

Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and

All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter.

Participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of oxycodone as in arm 1.

**Intervention Names:**

- Drug: Acetaminophen

- Drug: Ibuprofen

**Label:** Arm 2 - Non-Opioid Post-Op Pain Regimen

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm 1 - Opioid Post-Op Pain Regimen

- Arm 2 - Non-Opioid Post-Op Pain Regimen

**Description:** All patients will receive Acetaminophen 500 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge.

All patients will be instructed to take Acetaminophen around the clock for the first 72 hours and as needed thereafter.

**Name:** Acetaminophen

**Other Names:**

- Tylenol

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Arm 1 - Opioid Post-Op Pain Regimen

- Arm 2 - Non-Opioid Post-Op Pain Regimen

**Description:** All patients will receive Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge.

All patients will be instructed to take Ibuprofen around the clock for the first 72 hours and as needed thereafter.

**Name:** Ibuprofen

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Arm 1 - Opioid Post-Op Pain Regimen

**Description:** Patients randomized to Arm 1 will receive Oxycodone 5 mg orally every 4 hours as needed x 12 tablets at post-operative discharge

Patients randomized to Arm 2 will not receive an Oxycodone prescription at post-operative discharge.

However, participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of Oxycodone as in arm 1

**Name:** Oxycodone

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Patient reported pain on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" using the Likert pain scale from 0 to 10, where 0 is no pain and 10 is severe pain. A higher score indicates a worse outcome.

**Measure:** Numeric post-operative pain score

**Time Frame:** post-operative day 1 and post-operative day 7

#### Secondary Outcomes

**Description:** As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome.

**Measure:** Satisfaction with post-operative pain relief

**Time Frame:** post-operative day 1 and post-operative day 7

**Description:** As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome.

**Measure:** Satisfaction with post-operative mobility

**Time Frame:** post-operative day 1 and post-operative day 7

**Description:** Number of Oxycodone pills used by each patient by the end of post-operative day 7

**Measure:** Total narcotic consumption at one week post-operative

**Time Frame:** post-operative day 7

**Description:** As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "No" indicates a favorable outcome and "yes" indicates a worse outcome.

**Measure:** Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness)

**Time Frame:** post-operative day 1 and post-operative day 7

**Description:** Number of patients who request additional pain medications at the time of post-operative surveys, call provider phone line for additional pain medications, or return to an Emergency Department, clinic/office, etc due to a pain related issue.

**Measure:** Suboptimal pain control as assessed by the number of patients requesting additional medication or seeking unplanned medical care for a post-surgical pain-related concern

**Time Frame:** Within 30 days of surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Individuals with a fallopian tube (unilateral and/or bilateral)
* Age 18 years old and above
* Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure
* Benign indications for salpingectomy/tubal sterilization
* Agreeing to participate

Exclusion Criteria:

* Chronic pain syndromes patients including fibromyalgia
* Patients currently on long-term (i.e. for more than three months) opioid use
* Conversion to laparotomy
* Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone
* Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc)
* Salpingectomy performed for treatment of ectopic pregnancy
* Patients with a history of gastritis and/or GI bleeding

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mboraha1@jhmi.edu

**Name:** Mostafa Borahay, MD

**Phone:** 4439970400

**Role:** CONTACT

**Contact 2:**

**Email:** sosbor13@jh.edu

**Name:** Shannon Osborne, MD

**Phone:** 4105502786

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Baltimore

**Contacts:**

***Contact 1:***

- **Email:** mboraha1@jhmi.edu

- **Name:** Mostafa Borahay, MD

- **Phone:** 443-997-0400

- **Role:** CONTACT

**Country:** United States

**Facility:** Johns Hopkins Bayview Medical Center

**State:** Maryland

**Status:** RECRUITING

**Zip:** 21224

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins University

**Name:** Mostafa Borahay, MD

**Role:** PRINCIPAL_INVESTIGATOR

## 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: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Post Operative Pain

- ID: M10290

- Name: Infertility

- Relevance: HIGH

- As Found: Sterility

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M10291

- Name: Infertility, Female

- Relevance: HIGH

- As Found: Sterility, Female

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007246

- Term: Infertility

- ID: D000007247

- Term: Infertility, Female

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000058633

- Term: Antipyretics

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M13020

- Name: Oxycodone

- Relevance: HIGH

- As Found: Valve

- ID: M2340

- Name: Acetaminophen

- Relevance: HIGH

- As Found: Compared

- ID: M10102

- Name: Ibuprofen

- Relevance: HIGH

- As Found: Wound

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M29176

- Name: Antipyretics

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000082

- Term: Acetaminophen

- ID: D000007052

- Term: Ibuprofen

- ID: D000010098

- Term: Oxycodone

### Misc Info Module

- Version Holder: 2024-05-31
