Symptoms and General Pathology

All Conditions

Nervous System Diseases

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Participants randomized to the Yoga Condition will participate in a specialized yoga intervention.

Participants randomized to the Wait-List Control Condition will participate in a specialized yoga intervention once the Yoga Condition has completed their assigned intervention.

Participants randomized to the Yoga Condition will participate in an integrated yoga program consisting of yoga postures, breathing exercises, and concentration/meditation practices.

Yoga Condition

This randomized controlled trial will evaluate a yoga intervention for individuals who experience persistent pain following oncology surgery. The integrated yoga program will involve postures, breathing exercises, and concentration practices. Data will be collected at several time points (pre-, mid-, and post-intervention) for both the intervention and wait-list control conditions. The data will be analysed using linear mixed effects growth models. Results will be written up in manuscript format, published in a peer review journal, and disseminated at scientific research conferences.

Yoga for Persistent Pain Related to Oncology Surgery

Evaluation of the Transitional Pain Service Surgical Oncology Yoga Program for Individuals With Persistent Pain; a Pilot Randomized Controlled Trial

University Health Network, Toronto

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Bone Density Conservation Agents

Pregabalin

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Anti-Anxiety Agents

Pregabalin 150 mg twice daily, starting from the evening before surgery, continuing with two times 150mg per day for 12 days, and ending with one 150mg capsule every evening for the final 3 days.

Identical placebo capsules twice daily, starting from the evening before surgery, continuing with two capsules per day for 12 days, and ending with one capsule every evening for the final 3 days.

capsules identical to pregabalin but without active drug

Placebos

Benno Rehberg-Klug, MD

Stanislas Mathivon, MS

Ulrike Stamer, MD

Patrizia Sager, MD

Domitille Dereu, MD

Georges Savoldelli, MD

Delphine Bachmann

Sindy Monnier, MD

Magdalena Kohlik, MD

Marc Suter, MD

Chantal Berna-Renella, MD

Moira Baeriswyl, MD

This study will test the benefits and risks of using pregabalin perioperatively to prevent persistent postoperative pain in patients at high risk (\>30%) of developing such pain after breast cancer surgery.

BACKGROUND Persistent postsurgical pain occurs in more than 30% of patients undergoing breast cancer surgery. Evidence that gabapentinoids such as pregabalin may reduce the incidence of persistent postsurgical pain is ambiguous, potentially because in previous trials prophylactic treatment was administered to every patient undergoing surgery. The patients at low risk of long term pain, were exposed to side effects without much benefit to expect.

AIM Validating or refuting the utility of pregabalin to prevent long term post-operative pain in patients at high risk of persistent pain after breast cancer surgery.

METHODS Randomized, double-blind, placebo-controlled trial of pregabalin (2\*150mg from the day before breast cancer surgery until 2 weeks after surgery) in patients at high risk of persistent pain (\>30%). High-risk patients are identified by a risk score derived from a previous observational study. The main outcome is the incidence of clinically important pain (necessitating analgesic treatment, or having an intensity of \>3 at rest or \>5 on movement) at 3 months after surgery. Secondary outcomes are: incidence of neuropathic pain, pain interference, and incidences at 6 and 12 months of follow-up. In addition, side effects of pregabalin and the retention rate during the treatment period will be monitored, as well as patient expectancies.

RELEVANCE This is the first study for prevention of persistent postoperative pain which targets only high-risk patients, thus lowering a false negative outcome and averting the risk of side effects for patients at low risk.

The study is powered to show a reduction of the incidence of clinically important pain at 3 months of 20%. In the case the study shows that this can be achieved and pregabalin is well tolerated, the preventive use of pregabalin for breast cancer surgery would be justified at least in high-risk patients. On the other hand, a negative result would indicate the futility of pregabalin prevention, which is already in routine use in many hospitals.

double-blinded, randomized, placebo-controlled trial

study drugs (including identical placebos) and randomisation lists are prepared by the hospital pharmacy and are kept secret from the investigators until the end of the study and the "freezing" of the electronic data base (an interim analysis will be performed when data for the primary outcome are available for 60 patients per arm. Stopping rules are a difference in the incidence of the primary outcome of less than 8.2% (futility) or more than 19.9% (superiority)).

Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery

"Clinically important pain" is defined by: taking analgesics for pain at the surgical site OR average resting pain at the surgical site \>3/10 OR average movement-induced pain at the surgical site \>5/10.

blurred vision or diplopia, somnolence or sleepiness, abnormal thinking, confusional state, disturbed attention, and falls, as well as the effects noted in the "generic assessment of side effects" GASE questionnaire

incidence of neuropathic pain defined as a DN4-self-evaluation score ≥4

response to the question: "do you consider your pain as significant?"

response to the question "In retrospect, do you consider the preventive treatment worthwhile, given your pain outcome and your experience of taking the medication?")

responses to the questions: "How much pain do you expect 3 months from now?"" "How efficient do you think the study treatment is against the long-term pain (i.e. what is the success rate in %)?" "How well do you think it will work for you? (i.e. reduction in pain score 0-10)". Beliefs about treatment attribution after 10 days of treatment (question: "Do you think that you received the real drug or the placebo?")

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Yoga for Persistent Pain Related to Oncology Surgery	NCT03460028	Persistent Post...	Yoga Condition	18 Years - 90 Years	University Health Network, Toronto
Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery	NCT03216187	Persistent Post...	Pregabalin Placebos	18 Years -	University Hospital, Geneva

Spots Global Cancer Trial Database for persistent postoperative pain