Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block in Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction - a Non-inferiority Trial
ESP
1 other identifier
interventional
100
1 country
1
Brief Summary
The objective of this study is to assess the non-inferiority of analgesic efficacy of ESP vs PVB for patients undergoing unilateral mastectomy followed by immediate reconstruction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 21, 2022
October 1, 2022
1.6 years
October 18, 2022
October 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean difference of highest numerical rating score (NRS - a linear 11 point scale for self-reported pain) during admission in the recovery room
1 day
Difference in the ratio of the means of cumulative opioid dose (administered during admission in the recovery room)
1 day
Secondary Outcomes (7)
Success rate as defined by satisfactory spread of local anaesthetic agents on ultrasound
1 month
Ease of procedure (self-reported by anaesthetist on scale of 1-5)
1 month
Total opioid dose administered on day 0 and on day 1 (iv, subcutaneous or oral - converted to morphine equivalent dose (MEQ)
1 day after dose administration
Highest pain score on day 0 and 1
1 day
Time to readiness for discharge from the recovery room
1 day
- +2 more secondary outcomes
Study Arms (2)
paravertebral block
ACTIVE COMPARATORUltrasound-guided erector spinae plane block
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients (18 years of age or older)
- ASA I-III
- Patients scheduled for elective unilateral mastectomy followed by direct reconstruction
- Ability to give written and oral informed consent
You may not qualify if:
- Patient refusal
- Non-elective surgery
- Any contraindication to paravertebral block (including bleeding diathesis, coagulopathy, severe pulmonary disease )
- Allergy to amide-linked local anesthetics
- Cardiac conductivity disorders (e:g: 2nd and 3rd AV-block)
- Severe spinal malformations or history of extensive spine surgery - A history of spinal cord injury
- Known psychiatric disorder
- Chronic pain patients or patients already using opioids pre-operatively
- Infection of the skin at the site of needle puncture area - Inability to give oral and written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NKI-AvL
Amsterdam, North Holland, 1066CX, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2022
First Posted
October 21, 2022
Study Start
June 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
October 21, 2022
Record last verified: 2022-10