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ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy

C

Centre Jean Perrin

Status and phase

Completed
Phase 2

Conditions

Pain After Mastectomy

Treatments

Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm

Study type

Interventional

Funder types

Other

Identifiers

NCT01855529
2012-000227-40

Details and patient eligibility

About

After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and 68%. They begin after surgery and may persist until more than 6 months. They respond poorly to opioid analgesics impair the quality of life.

Among the different postoperative analgesic techniques used, the use of a local anesthetic infiltration continues catheter has advantages including improving the quality of analgesia, with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine consumption, improving the quality of life of patients.

Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in the control of postoperative pain after mastectomy.

Enrollment

150 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age> 18 years

  • ASA I-II, WHO 0-1
  • mastectomy alone, mastectomy + GGS + mastectomy CA
  • No previous history of chronic pain requiring regular intake of analgesics or long-term
  • Failure to take opioids within 30 days before surgery

Exclusion criteria

  • Long-term treatment analgesic or taking opioids within 30 days before surgery
  • Concurrent treatment with a drug test, participation in another therapeutic clinical trial within <30 days
  • proven allergy to local anesthetics of the amide
  • Skin Inflammation
  • Sepsis local
  • Kidney failure, liver failure, severe or poorly controlled diabetes
  • Inability to respond to the assessment of pain using a visual analogue scale (VAS) or a numerical scale (FR).
  • mastectomy with immediate breast reconstruction

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups, including a placebo group

Ropivacaine arm
Experimental group
Description:
Ropivacaïne 2 mg/ml 10ml/h
Treatment:
Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm
NaCl arm
Placebo Comparator group
Description:
NaCl 0,9% 250ml 10 ml/h
Treatment:
Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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