Chronic pain after breast cancer surgery.

Relative Contributions of Humoral and Nerve Nociceptive Inputs to Postoperative Central Sensitisation and Pain: Interaction of Extended Perioperative COX-2 Inhibition and Local Anaesthetic Blockade for Breast Malignancy Surgery.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20830

Enrollment

110

Registered

2009-05-03

Start date

2006-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pain, breast cancer, surgery, sensitisation, mechanism, cox-2, quantitative sensory testing

Interventions

After informed patient consent, patients will be randomised to either an active or placebo treatment group. On the morning of surgery, the patient will receive oral midazolam premedication (7.5 mg). I

Eligibility

Inclusion criteria

Inclusion criteria: 110 patients (n=55 per group) due to undergo elective first surgery for malignancy of the breast at UMC St. Radboud or Bernhoven Ziekenhuis in Oss.

Exclusion criteria

Exclusion criteria: 1. Previous breast surgery; 2. Any type of chronic pain syndrome; 3. Regular analgesic medication (including opioids, NSAIDs or COX-2 inhibitors) for the 2 weeks preceding surgery; 4. Pre-existing central nervous system pathology (e.g. stroke, dementia); 5. Conditions predisposing to neuropathy (e.g. diabetes mellitus, alcohol abuse); 6. Inability to comply with testing procedures or to give informed consent; 7. Presence of contra-indications to COX-2 therapy (e.g. impaired renal or cardiac function (including angina pectoris), untreated hypertension, active or recent gastrointestinal ulceration); 8. Contraindications to paravertebral blockade.

Design outcomes

Primary

Measure	Time frame
Neuroplasticity, e.g. central sensitisation as demonstrated by quantitative sensory testing, at one month after surgery.	—

Secondary

Measure	Time frame
1. Neuroplasticity at other time points after surgery; 2. Acute and chronic clinical pain measures (pain scores, analgesic consumption, pain questionnaires); 3. Other pain outcome measures (incidence of phantom pain, pain maps, analgesia complications); 4. Surgical outcome measures (complications); 5. Patient satisfaction and well-being (including nausea and vomiting, opioids symptom distress score SDS).	—

Measure

Time frame

1. Neuroplasticity at other time points after surgery; 2. Acute and chronic clinical pain measures (pain scores, analgesic consumption, pain questionnaires); 3. Other pain outcome measures (incidence of phantom pain, pain maps, analgesia complications); 4. Surgical outcome measures (complications); 5. Patient satisfaction and well-being (including nausea and vomiting, opioids symptom distress score SDS).

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Contacts

Public ContactM.A.H. Steegers

P.O.B. 9101/Internal Mail 550

m.steegers@anes.umcn.nl+31(0)24 3611111 / +31 (0)24 3668120

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)