Trial Outcomes & Findings for TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT (NCT NCT01398982)

Results Overview

The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

93 participants

Primary outcome timeframe

first postoperative 48 hours

Results posted on

2015-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	44	49
Overall Study COMPLETED	38	47
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Isotonic Saline (Control Group) n=44 Participants 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.	Bupivacaine (Study Group) n=49 Participants 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.	Total n=93 Participants Total of all reporting groups
Age, Continuous	50.5 years STANDARD_DEVIATION 8.4 • n=5 Participants	52.1 years STANDARD_DEVIATION 8.3 • n=7 Participants	51.4 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	49 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	44 participants n=5 Participants	49 participants n=7 Participants	93 participants n=5 Participants

PRIMARY outcome

Timeframe: first postoperative 48 hours

The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.

Outcome measures

Outcome measures
Measure	Isotonic Saline (Control Group) n=38 Participants At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or 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.	Bupivacaine (Study Group) n=47 Participants At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or 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.
Mean Total Opioid Consumption	30.0 mg Standard Deviation 19.1	20.7 mg Standard Deviation 20.1

SECONDARY outcome

Timeframe: In-patient hospital stay average of 4 - 5 days

Total in-hospital cumulative opioid consumption levels

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In Hospital postoperative measures, average 4-5 days

Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge

Pain Disability Index Scores

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In-patient hospital stay, average 4-5 days

Time to first bowel movement (# of days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In-patient hospital stay, average 4-5 days

Total in-hospital cumulative anti-nausea consumption

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In-patient hospital stay, first post operative 48 hours

Quality of Recovery (QOR) score (0-18)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In-patient hospital stay, average of 4-5 days

Duration of hospital stay (# of days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In Hospital postoperative measures, average 4-5 days

Postoperative nausea and vomiting (score of 0-3)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In Hospital postoperative measures, average 4-5 days

Sedation score in-patient

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge

Short-form McGill Pain Questionnaire Score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge

Hospital Anxiety and Depression Scale Score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge

Short-form health-related quality of life 36 Scores

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In-patient hospital stay, average 4-5 days

Time to ambulation (# of days)

Outcome measures

Outcome data not reported

Adverse Events

Isotonic Saline (Control Group)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Bupivacaine (Study Group)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Isotonic Saline (Control Group) n=44 participants at risk At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or 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.	Bupivacaine (Study Group) n=49 participants at risk At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or 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.
Surgical and medical procedures hematoma or revision of vessel anastomoses	4.5% 2/44 • Number of events 2	6.1% 3/49 • Number of events 3

Additional Information

Kate Butler

UHN

Phone: 416-340-4800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place