Breast Cancer Clinical Trial
Official title:
The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery. A Double Blind, Randomised, Placebo Controlled Trial.
Verified date | February 2023 |
Source | Zealand University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators have developed a novel ultrasound-guided nerve block indicated primarily for breast cancer surgery that mimic a thoracic paravertebral block (TPVB) - hitherto the internationally accepted regional anesthesia golden standard for anesthesia of the hemithorax - but hypothetically without the risks of adverse events associated with the TPVB (i.e. pneumothorax, risk of bleeding in the thoracic paravertebral space, random and unmanageable epidural spread etc.). The investigators have already tested the anatomical- and block execution hypothesis in a randomized cadaveric study, and the investigators now have anatomical proof of concept for the functionality of the block technique. The investigators have also conducted a small clinical pilot study with very promising results. The investigators 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. The 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 or ductal carcinoma in situ. The 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.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 8, 2021 |
Est. primary completion date | December 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Scheduled for elective unilateral mastectomy and primary reconstructive (UMPR) surgery with subpectoral implant due to breast cancer and ductal carcinoma in situ - Age 18 years or above at the date of inclusion - Have received thorough information, orally and in written, and signed the "Informed Consent" form on participation in the study. Exclusion Criteria: - Scheduled for elective UMPR surgery due to breast cancer and DCIS 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 (SCTL, ITTC etc.) necessary for the block execution - Substantial co-morbidity, ASA>3 - Severe hypovolemia - Pregnant or breastfeeding |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde | Roskilde | Zealand Region |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital | Copenhagen University Hospital, Denmark |
Denmark,
Nielsen MV, Moriggl B, Hoermann R, Nielsen TD, Bendtsen TF, Borglum J. Are single-injection erector spinae plane block and multiple-injection costotransverse block equivalent to thoracic paravertebral block? Acta Anaesthesiol Scand. 2019 Oct;63(9):1231-1238. doi: 10.1111/aas.13424. Epub 2019 Jul 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morphine Consumption | The primary aim of this study is total morphine consumption in the first 24 postoperative hours (data from PCA pump and the patient's medical record). | 24 hours | |
Secondary | Pain intensity | 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 [ arrival at the ward - 4 hrs. postop ] ] 4 hrs. postop - 8 hrs. postop ] ] 8 hrs. postop - 12 hrs. postop ] ] 12 hrs. postop - 16 hrs. postop ] ] 16 hrs. postop - 20 hrs. postop ] ] 20 hrs. postop - 24 hrs. postop ] |
24 hours | |
Secondary | Morphine consumption at 4, 8, 12, 16 and 20 postoperative hours. | NRS score will be recorded electronically in the PCA-pump when morphine is administrated. All patients must enter NRS 0-10 on the PCA pump prior to morphine bolus administration. | 20 hours | |
Secondary | Duration of block (time to first opioid). | How long time does the MICB work? | 24 hours | |
Secondary | Patient satisfaction with application of the block. | Patient is asked immediately after block application, Numeric Rating Scale (0-10, 0 = no pain, 10 = worst pain) | Immediately after application | |
Secondary | The degree of morphine-related side effects (PONV, itching, fatigue, etc.). | PONV. 0-3; 0=No nausea. 3=Unmanageable nausea | 24 hours | |
Secondary | Time from operation (T0) to ambulation (bed to chair to walking) | When is the patient capable to ambulate; ie. going to the bathroom by themself | 24 hours | |
Secondary | Time to discharge (days). | When is the patient discharged? | 5 days (anticipated) | |
Secondary | Quality of recovery | Quality of Recovery - 15 score (QoR15). Preoperatively compared to twice postoperatively. Preoperatively the patients are asked to fill in the validated Quality of Recovery Questionnaire QoR1536 questionnaire repeated at T0+24hrs. and 14 days after surgery (possibly by phone interview). The QoR15 questionnaire results in a score of 0-150. | 24 hours and 14 days |
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