TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT

PHASE4CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Transversus Abdominis Plane (TAP) Block CatheterDIEP or Free MS-TRAM Breast ReconstructionLocal Pain ManagementAbdominal/ Donor Site
Interventions
DRUG

Bupivacaine (study group)

At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.

DRUG

Isotonic saline (control group)

At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.

Trial Locations (1)

M5G 2C4

Toronto General Hospital, Toronto

All Listed Sponsors
collaborator

Canadian Society of Plastic Surgeons

OTHER

collaborator

The Plastic Surgery Foundation

OTHER

lead

University Health Network, Toronto

OTHER

NCT01398982 - TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT | Biotech Hunter | Biotech Hunter