Surgical Versus Anaesthetic Placement of Rectus Sheath Catheters
SPARC
Surgical Placement Versus Anaesthetic Placement of Rectus Sheath Catheter for Pain Relief Following Major Abdominal Surgery (SPARC). A Single Centre Randomised Controlled Trial
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
This is a single centred randomized controlled trial comparing surgeon versus anaesthetist inserted rectus sheath catheters for management of analgesia post major abdominal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
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
First Submitted
Initial submission to the registry
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMay 3, 2017
April 1, 2017
6 months
April 26, 2017
April 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Time taken to insert rectus sheath catheters
This will be recorded in theatre on a stopwatch and recorded.
under 15 minutes
Secondary Outcomes (6)
Pain scores
4 days
Peri-operative analgesic use
4 days
Catheter issues
4 days
Duration of catheter use
4 days
TIme to diet and mobilisation
likely 1-3 days
- +1 more secondary outcomes
Study Arms (2)
Surgeon-inserted
ACTIVE COMPARATORRectus sheath catheter will be inserted under direct vision / palpation of the space at the end of the operation.
Anaesthetist-inserted
ACTIVE COMPARATORRectus sheath catheter will be inserted under ultrasound guidance by the anaethetist.
Interventions
Insertion of rectus sheath catheter via either method
Eligibility Criteria
You may qualify if:
- Patients aged over 18 years
- Able to provide informed consent
- Undergoing elective, open colorectal surgery or emergency laparotomy via a midline incision extending above the umbilicus
- Weight of 50kg or over to standardise the analgesia given.
You may not qualify if:
- Weight of less than 50kg
- Patients unable to consent
- Age under 18 years
- Inability to insert RSC - local infection or severe coagulopathy
- Allergy to local anaesthetic
- Chronic pre-operative use of strong opioids or gabapentins and or chronic pain syndromes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patients will be blinded to the intervention that they are randomized to intraoperatively.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Colorectal Surgeon
Study Record Dates
First Submitted
April 26, 2017
First Posted
May 3, 2017
Study Start
June 1, 2017
Primary Completion
December 1, 2017
Study Completion
June 1, 2018
Last Updated
May 3, 2017
Record last verified: 2017-04