Post-Operative Pain Expertise

Acute Pain Models at DVCR

The Dr. Vince Clinical Research team has broad expertise in pain therapeutics and with bunionectomy and third molar extraction pain models, led by our Executive Vice President, Scientific Affairs, Lynn R. Webster, MD, an internationally recognized clinical research expert in pain and addiction medicine. Since 2003, Dr. Webster has served as an investigator or co-investigator on over 350 clinical trials, giving him significant expertise in human pain models, experimental pain models, human abuse potential, and assessing drugs’ effects on respiratory depression.

The staff at DVCR possess expertise in acute post-operative pain studies with a skilled proficiency and focus directed on the administration of the protocol required pain intensity assessments. The most common assessments include the Numeric Rating Scale (NRS) or the Numeric Pain Rating Scale (NPRS); Visual Analog Scale (VAS) and Overall Global Evaluation.

We acknowledge that pain is subjective and different for each volunteer. Our rigorous documented staff training incorporates acute pain methodology developed by the pioneers of acute pain study design. Our expertly trained staff follow a standardized approach with each pain assessment, eliminating bias in the volunteer/rater interaction. The outcome of these assessments can generate valuable, reproducible data that our clients will use to make informed decisions on the safety/efficacy/analgesic effect of an investigational product. Therefore, having a site with specialized trained staff is the very key to the success of our client’s projects.

Acute pain trials are conducted in volunteers who have undergone a surgical procedure. The two most common pain models are bunionectomy and third molar extractions:

Lynn R. Webster, MD

Executive Vice President, Scientific Affairs

Acute Pain Models at DVCR

The Dr. Vince Clinical Research team has broad expertise in pain therapeutics and with bunionectomy and third molar extraction pain models, led by our Executive Vice President, Scientific Affairs, Lynn R. Webster, MD, an internationally recognized clinical research expert in pain and addiction medicine. Since 2003, Dr. Webster has served as an investigator or co-investigator on over 350 clinical trials, giving him significant expertise in human pain models, experimental pain models, human abuse potential, and assessing drugs’ effects on respiratory depression.

Lynn R. Webster, MD

Executive Vice President, Scientific Affairs

The staff at DVCR possess expertise in acute post-operative pain studies with a skilled proficiency and focus directed on the administration of the protocol required pain intensity assessments. The most common assessments include the Numeric Rating Scale (NRS) or the Numeric Pain Rating Scale (NPRS); Visual Analog Scale (VAS) and Overall Global Evaluation.

We acknowledge that pain is subjective and different for each volunteer. Our rigorous documented staff training incorporates acute pain methodology developed by the pioneers of acute pain study design.Our expertly trained staff follow a standardized approach with each pain assessment, eliminating bias in the volunteer/rater interaction. The outcome of these assessments can generate valuable, reproducible data that our clients will use to make informed decisions on the safety/efficacy/analgesic effect of an investigational product. Therefore, having a site with specialized trained staff is the very key to the success of our client’s projects.

Acute pain trials are conducted in volunteers who have undergone a surgical procedure. The two most common pain models are bunionectomy and third molar extractions:

Bunionectomy

A bunion is an excess or misaligned bone in the joint. “Acquired deformity caused by abnormal mechanics at the first metatarsophalangeal joint” (1). A bunionectomy involves excision of the medial aspect of the first metatarsal with osteotomy and internal fixation. DVCR’s standard surgical procedure is the Austin bunionectomy.

The Post-Bunionectomy Pain Model (PBPM) was modeled on the lessons learned from the now refined Dental Impaction Pain Model (DIPM). The PBPM offered plentiful patient recruitment, standardized post-operative care in specialized clinical research centers, and standardized surgical, perioperative, and anesthesia protocols. The PBPM’s popularity among drug and device developers surged because it was recognized that these patients experienced a more prolonged course of acute pain than did patients after dental impaction surgery. It has now become possible to retain patients in research settings for 2 to 5 days to better understand their pain course over time. Although there remain questions about optimal repeat dosing schedules, possible interactions between rescue drug and investigational drug, and assay sensitivity over time, this relatively new acute pain model has proven to be useful in drug development (2).

The bunionectomy model protocol design offers both single and multiple-dose regimens. The comparators may include a placebo, a different active comparator, and/or a lower dose of the study treatment. Evaluation of two or more different doses of a study medication can provide clinically useful information.

On-Site Surgical Suite

Key factors in all bunionectomy trials include standardizing the anesthesia regimen and the postoperative care of each subject. This decreases variability across sites when these trials are being conducted in multiple sites.

One of DVCR’s advantages lies in our ability to seamlessly integrate both the surgical procedure and inpatient confinement within our facility. Having an onsite dedicated procedure room for surgeries is essential for ensuring a sterile and controlled environment for our medical procedures. It allows medical professionals to perform surgeries safely and efficiently while controlling the variables that other sites may encounter by transporting the volunteers from a surgical facility to a research facility. Properly equipped procedure rooms contribute to better volunteer outcomes and minimize the risk of complications.

  • Surgical Team:
  • KBoard-certified Podiatrists
  • KBoard-certified Anesthesiologist
  • KExperienced RNs
  • KDedicated Surgical Manager
  • Continuous subject monitoring with emergency equipment
  • Seamless flow between Pre-Op and PACU area
  • SOPs for best practices

Pre-operative room

Private suite for post-surgical recovery and per protocol assessments

On-Site Surgical Suite

Key factors in all bunionectomy trials include standardizing the anesthesia regimen and the postoperative care of each subject. This decreases variability across sites when these trials are being conducted in multiple sites.

One of DVCR’s advantages lies in our ability to seamlessly integrate both the surgical procedure and inpatient confinement within our facility. Having an onsite dedicated procedure room for surgeries is essential for ensuring a sterile and controlled environment for our medical procedures. It allows medical professionals to perform surgeries safely and efficiently while controlling the variables that other sites may encounter by transporting the volunteers from a surgical facility to a research facility. Properly equipped procedure rooms contribute to better volunteer outcomes and minimize the risk of complications.

  • Surgical Team:
  • KBoard-certified Podiatrists
  • KBoard-certified Anesthesiologist
  • KExperienced RNs
  • KDedicated Surgical Manager
  • Continuous subject monitoring with emergency equipment
  • Seamless flow between Pre-Op and PACU area
  • SOPs for best practices

Pre-operative room

Private suite for post-surgical recovery and per protocol assessments

Third Molar Extraction

The third molar extraction model was the model of choice for analgesic drug development which began in the 1980s. This model offers enrollment of a relatively homogeneous population of younger, healthy volunteers with excellent assay sensitivity, reproducibility, and greatly accelerated timelines.

Dental studies, like bunionectomy studies are designed as randomized, double-blind, placebo-controlled studies and can be single or multi-dose designs. The protocol inclusion criteria varies and may involve the extraction of 1-4 third molars. Our facility is uniquely designed to conduct the surgeries and house the volunteers for the per protocol time requirements.

Reach Out Today

If you would like to learn more about how DVCR can support your upcoming acute pain model assessment, please contact us.

References

1 Barney Leveau, Normal and Abnormal Function of the Foot: Clinical Biomechanics, vol 2., Physical Therapy, Volume 59, Issue 3, March 1979, Page 352, https://doi.org/10.1093/ptj/59.3.352a

2 Gilron I, Carr DB, Desjardins PJ, Kehlet H. Current methods and challenges for acute pain clinical trials. Pain Rep. 2018 Apr 2;4(3):e647. doi: 10.1097/PR9.0000000000000647. PMID: 31583333; PMCID: PMC6749920.