Postoperative pain following mastectomy and reconstructive surgery due to breast cancer. MedDRA version: 20.0 Level: LLT Classification code 10026881 Term: Mastectomy radical System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10051042 Term: Plastic surgery NOS System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10006188 Term: Breast cancer female NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Ropivacaine
Product Name: Ropivacaine
Pharmaceutical Form: Injection
INN or Proposed INN: Ropivacaine
Other descriptive name: ROPIVACAINE HYDROCHLORIDE
Concentration unit: mg/ml milligram(
Sponsors
Associate Professor, Consultant Jens Børglum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Scheduled for elective unilateral mastectomy and primary reconstructive surgery (UMPR) with subpectoral implant due to breast cancer Age above/equal to 18 years at the date of inclusion Have received thorough information, orally and in written, and signed the “Informed Consent” form on participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Scheduled for elective UMPR surgery due to breast cancer combined with simultaneous contralateral major breast surgery (mastectomy, mastopexy and subpectoral breast reconstruction). Minor contralateral surgery (e.g. lipofilling) are accepted. Scheduled free flap reconstructive surgery Inability to cooperate Inability to speak, read and understand Danish Allergy to local anaesthetics or opioids Daily intake of opioids, according to the investigators decision Illegal drug and/or substance abuse, according to the investigators decision Local infection at the site of injection or systemic infection Difficult sonoanatomical visualisation of the target area necessary for the block execution Substantial co-morbidity, ASA>3 Severe hypovolemia Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We wish to conduct a randomized, placebo controlled and double blind study, comparing the effect of the ultrasound-guided multiple-injection costotransverse block (MICB) vs. placebo. Our aim with this study is to investigate the efficacy of the MICB vs. placebo in patients undergoing unilateral mastectomy and primary reconstructive surgery due to breast cancer. Our hypothesis is, that the unilateral MICB will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale pain score (0-10) and opioid related side effects. ;Secondary Objective: Not applicable;Primary end point(s): The primary end point of this study is total morphine consumption in the first 24 postoperative hours.;Timepoint(s) of evaluation of this end point: 24 hours postoperative. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pain intensity (NRS 0-10/10) in the study period at T0 (arrival in the PACU), after 15 minutes, 30 minutes, 45 minutes and one hour. And pain intensity (NRS 0-10/10) in the intervals o [ arrival at the ward - 4 hrs. postop ] o ] 4 hrs. postop – 8 hrs. postop ] o ] 8 hrs. postop – 12 hrs. postop ] o ] 12 hrs. postop – 16 hrs. postop ] o ] 16 hrs. postop – 20 hrs. postop ] o ] 20 hrs. postop – 24 hrs. postop ] Morphine consumption at 4, 8, 12, 16 and 20 postoperative hours. Duration of block (time to first opioid). Patient satisfaction with application of the block. The degree of morphine-related side effects (PONV, itching, fatigue, etc.). Time from operation to ambulation (bed to chair to walking) Time to discharge (days). Quality of Recovery – 15 score (QoR15). The incidence of chronic pain 1 year after surgery ;Timepoint(s) of evaluation of this end point: The research period is 14 days postoperative with interrim timepoints regarding block performance and acute postoperative pain. Chronic pain follow-up at 1 year. | — |
Countries
Denmark
Contacts
Public ContactJens Børglum
Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde
Outcome results
None listed