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Principal Investigator

Srdjan S. Nedeljkovic, MD

Departments of Anesthesiology, Perioperative and Pain Medicine
Assistant Professor  of Anesthesia | Harvard Medical School

Dr. Nedeljkovic is actively involved with a number of drug and equipment development companies to develop innovative pain therapeutics. He has been working with Vivozon, a drug development company from South Korea in initiating the first human clinical trial of a novel non-narcotic analgesic substance for postoperative pain. He has been working with Pacira Pharmaceuticals to conduct the first trials assessing the efficacy and safety of Exparel, a liposomal bupivacaine, preparation, as a nerve blocking agent. Recently, he has been working to assess the clinical efficacy of Exparel in an obstetrical population of women who have undergone Cesarean section.
Dr. Nedeljkovic is collaborating with Sorrento Pharmaceuticals to conduct the first human trial of epidural injection of resiniferitoxin, a novel substance that may create analgesia by permanently ablating A-delta and C-fiber nociceptors while preserving normal neurological function. Dr. Nedeljkovic is also in the process of initiating a trial to assess the clinical utility of pharmacogenomic testing both in the perioperative patient population and for patients who seek care in the pain management center. In these efforts, Dr. Nedeljkovic has established excellent collaborations with colleagues at Massachusetts General Hospital and also with other investigators nationally and internationally.
Recent completed projects include the Back Pain Outcomes Longitudinal Data Collection grant. This federally funded grant involved establishing a registry of patients age 65 and older who present with an initial onset of low back pain. Patients were assessed over the course of two years for clinical characteristics and treatment outcomes. Dr. Nedeljkovic is also one of the lead investigators of a study to assess the efficacy of epidural steroid injections for older adults with lumbar spinal stenosis, comparing outcomes between patients who received local anesthetic alone vs a combination of steroid and local anesthetic.

Current and Ongoing Research Projects

2015-full enrollment

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Dose Finding Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Laparoscopic Colorectal Surgery
Principal investigator
The study is evaluating the safety and efficacy of a novel non-opioid analgesic for pain management after colorectal surgery.

2017- full enrollment

A Multicenter, Open-Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated with Cancer
Site PI
This study will evaluate the dose of a novel analgesic for intractable cancer pain.

2017- full enrollment

A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Safety and Efficacy of EXPAREL When Administered via Infiltration into the Transversus Abdominis Plane (TAP) Versus Bupivacaine Alone in Subjects Undergoing Elective Cesarean Section
Site PI
This is a Phase 4 FDA study that will evaluate the clinical efficacy of a long acting liposomal buivacaine preparation for the treatment of postoperative pain after Cesarean section.

2018- full enrollment

Prospective Observational Study to Evaluate the Clinical Utility of Pharmacogenomic Testing in Perioperative and Pain Management Patients
Principal Investigator
This study will involve screening patient who are planning to undergo major surgery and screening of patients who have chronic pain and are seeking care in the pain clinic, and then assessing the clinical utility of performing pharmacogenomic testing in these patient populations.

Recently Completed Research Projects

2010-2013

Back Pain Outcomes using Longitudinal Data

AHRQ Grant R01-HS019222-01, CFDA No. 93.715
Site PI
The project evaluated treatments and outcomes for older patients with back pain.

2011-2014

Urine toxicology screen review

Co-investigator
This retrospective chart review will evaluate the frequency of abnormal urine screens in new patients seen at the Pain Management Center

2012-2016

Effects of Intravenous Lidocaine on Endometriosis Pain

Pfizer, Inc.
Co-investigator
The study evaluated the efficacy of intravenous lidocaine as a treatment of endometriosis pain.

2013-2016

Long Term Outcomes of the Randomized Controlled Trial of Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS) Study

PCORI Cycle II awardee Contract No: CE-12-11-44469
Site PI
The study evaluated long-term outcomes in patients with spinal stenosis after lumbar ESI.

2013-2016

Back Pain Outcomes Longitudinal Data (BOLD) Extension of Research

AHRQ: 1R01HS022972-01
Site PI
This study studied long term outcomes in older adults after an episode of back pain, enhanced stakeholder engagement and assessed capability of BOLD data infrastructure to meet stakeholder needs.

2016-2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block with EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty

Site PI
This study evaluated the safety and efficacy of a long acting liposomal bupivacaine formulation to reduce pain after total knee arthroplasty.

2016-2017

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block with EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Shoulder Arthroplasty or Rotator Cuff Repair

Site PI
This study evaluated the safety and efficacy of a long acting liposomal bupivacaine formulation to reduce pain after shoulder surgery.

Srdjan S. Nedeljkovic, MD

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