Post-Op Pain

Committed to Research in Acute Pain and Post-Operative Surgical Models

To be successful in the acute post-operative pain space, you need a CRO partner with a demonstrated track record of success. The experience required comes from years of developing relationships with KOLs and their high-quality, high-enrolling sites, successfully navigating FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP), and maintaining a team of experts in acute pain who know how to execute these fast-enrolling studies.

Why Choose Rho?

Our experts understand both the challenges and FDA requirements for using surgical models in the development of products to treat acute pain, including the need to incorporate Human Abuse Assessments.

Our operational experts can handle the fast enrollment of these trials, which requires contemporaneous monitoring and real-time communications with sites. They know the ins and outs of handling scheduled substances, and they provide fast start up and a data cleaning strategy that will ensure enrollment and database lock timelines are met, and often exceeded.

Our regulatory experts have helped sponsors achieve product approval in this competitive space by interacting with FDA’s DAAP on their behalf, providing insights into development programs and protocols, and advising on Human Abuse Potential (HAP) issues.

Expertise in Action

Rho’s team of post-operative pain experts routinely complete enrollment of clinical studies ahead of schedule. Some recent examples include:

  • Completed enrollment 7 weeks early for a Phase III Bunionectomy trial with 500 subjects.
  • Locked a database for a Phase II Bunionectomy trial a full month ahead of schedule.
  • Completed enrollment 3 weeks ahead of schedule for a Phase III Abdominoplasty study.
  • Successfully negotiated with DAAP on the primary estimate for multiple pivotal trials.
  • Completed enrollment 4 weeks early on a Phase II molar extraction study with 108 subjects.

50+

clinical sites in the acute pain space

9

products reviewed by FDA’s pain division (7 approved)

30+

FDA Type A/B/C meetings in the pain division

6

advisory committee meetings in the pain division (both back room and bullpen)

Completed studies in recruited surgical pain models, including

  • 3rd molar extraction
  • Abdominoplasty
  • Anesthesia induction
  • Bunionectomy
  • Hysterectomy
  • Inguinal hernia repair
  • Total knee arthroplasty (TKA)
  • Ventral hernial repair

Human Abuse Potential

  • Design and operational conduct of HAP studies
  • Statistical considerations and powering of HAP studies
  • Clinical data analyses needed in HAP studies

Assessments

  • Patient Reported Outcomes – paper and electronic
  • Double stopwatch

Scales

  • VAS
  • NRS
  • Likert pain scales
  • Global impression scales
  • LAST
  • Southampton and other assessments of wound healing

Endpoints

  • Number of Events per Time period
  • Opioid Sparing
  • Time to Resolution/Resolution in xx hours

We’ve worked with

250+

clinical sites who focus on pain trials

25+

years in the acute pain clinical development space

A Sample of Recent Acute Post-Op Pain Experience

Phase

Sites

Patients

Indication

IIa

1

20

Abdominoplasty

III

5

300

Abdominoplasty

III

2

60

Bunionectomy

III

16

400

Bunionectomy

III

3

83

Bunionectomy

III

6

522

Bunionectomy

III

4

375

Bunionectomy

III

3

340

Bunionectomy

II

5

320

Bunionectomy

III

1

125

Bunionectomy

III

3

300

Bunionectomy

II

2

45

Hernia

III

11

159

Hernia

III

24

319

Hernia

III

16

412

Hernia

III

25

500

Hernia

II

6

45

TKA

III

6

154

TKA

II

1

52

Dental

II

1

110

Dental

III

2

110

Dental

III

20

399

Anesthesia Induction
(all comers)

III

20

399

Anesthesia Induction
(all comers)

II

2

45

Hysterectomy

II

6

18

Hysterectomy

[Rho] staff have been a joy to work with over the years. Rho separates themselves from their competition with a lack of turnover of key personnel, including project management, and the training they provide to both their in-house and contracted CRAs.

Patrick McLaughlin, CEO, Anaheim Clinical Trials

Webinar

Challenges with Fast Enrolling Post-Operative Acute Pain Studies

There are a lot of resources on how to deal with slow enrolling studies, but what about challenges with studies that enroll very quickly?  Enrollment can be very fast for post-operative acute pain studies which brings with it unique challenges in study execution. 

Watch Webinar
Becky Baggett
Presenter

Becky Baggett

Senior Project Director

Ben Vaughn
Presenter

Ben Vaughn

Chief Strategist, Biostatistics & Protocol Design

Featured Content

Article

Six Things to Consider When Selecting a CRO for Your Next Pain Trial

Read more
Ebook

Development of Successful Phase 2 Analgesia Protocols

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Thank you to the entire Rho team for locking this database on time! I truly appreciate the team’s dedication and hard work to get our acute pain program to this important milestone, despite challenging timelines.

Director, Clinical Operations

Success Stories

Experienced Clinical Trial Management Delivers Phase 3 Bunionectomy Trial Ahead of Schedule

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Preparation and Expertise Result in Successful Advisory Committee Meeting for Analgesia Product

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Join us on our mission to bring relief to the millions in pain. We proudly invite you to experience Rho.

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