Trial Outcomes & Findings for Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection (NCT NCT01339273)
NCT ID: NCT01339273
Last Updated: 2020-02-05
Results Overview
Total morphine consumption in the first 48 hours after the surgery will be calculated from the drug chart and the Patient controlled analgesia(PCA)pump.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
48 hours after the operation
Results posted on
2020-02-05
Participant Flow
Participant milestones
| Measure |
TAP Block
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
TAP Block
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.7 years
n=28 Participants
|
67.8 years
n=28 Participants
|
68.3 years
n=56 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=28 Participants
|
15 Participants
n=28 Participants
|
27 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=28 Participants
|
13 Participants
n=28 Participants
|
29 Participants
n=56 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
28 Participants
n=28 Participants
|
28 Participants
n=28 Participants
|
56 Participants
n=56 Participants
|
|
BMI
|
26.9 Kg/m2
n=28 Participants
|
28.9 Kg/m2
n=28 Participants
|
27.7 Kg/m2
n=56 Participants
|
PRIMARY outcome
Timeframe: 48 hours after the operationTotal morphine consumption in the first 48 hours after the surgery will be calculated from the drug chart and the Patient controlled analgesia(PCA)pump.
Outcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Morphine Consumption in the First 48hours After the Operation
|
47.3 mg
Interval 36.2 to 58.5
|
46.7 mg
Interval 36.2 to 57.3
|
SECONDARY outcome
Timeframe: 48 hours after the operationNumerical Rating Scores for Pain (0-10) 0= no pain 10= severe pain
Outcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Numerical Rating Pain Scores at 48 Hours Postoperatively
|
2 units on a scale
Interval 1.5 to 5.0
|
2 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 48 hours after the operation0-10 0= no nausea 10=severe nausea
Outcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Nausea Score at 48 Hours Postoperatively
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.25
|
SECONDARY outcome
Timeframe: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.Population: data were not collected
The time will be calculated from the drug chart looking up when the first dose of rescue morphine was administered
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.Time will be calculated from the nursing notes and patient diary, when the patient was first mobilised.
Outcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Time to Mobilisation
|
1 days
Interval 0.5 to 2.0
|
1 days
Interval 0.5 to 2.0
|
SECONDARY outcome
Timeframe: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.Time will be calculated from the nursing notes and patient diary, when the patient had first successful intake of oral fluids.
Outcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Time to Successful Intake of Fluids
|
1.5 days
Interval 0.5 to 3.0
|
2 days
Interval 0.5 to 4.0
|
SECONDARY outcome
Timeframe: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.Time will be calculated from the nursing notes and patient diary, when the patient resumed normal diet.
Outcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Time to Resumption of Normal Diet
|
2 days
Interval 1.0 to 5.0
|
2.5 days
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.Time will be calculated from the nursing notes and patient diary, when the patient had the first bowel motion.
Outcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Time to First Bowel Motion
|
2.5 days
Interval 1.0 to 5.0
|
3 days
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.Time will be calculated from the nursing notes and patient diary, when the patient first passed flatus.
Outcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Time to First Flatus
|
1 days
Interval 0.5 to 3.0
|
1 days
Interval 0.3 to 3.0
|
SECONDARY outcome
Timeframe: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.Time will be calculated from the medical notes, when the decision that the patient is medically fit to be discharged was made.
Outcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Time to Medically Fit to Discharge
|
4.5 days
Interval 3.0 to 9.0
|
4.5 days
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
TAP Block
n=28 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Total Morphine Consumption at 24hours
|
30.9 mg
Interval 24.0 to 37.8
|
31 mg
Interval 24.1 to 37.9
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: data lost during follow up
Outcome measures
| Measure |
TAP Block
n=21 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=23 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Nausea at 24hours Post Operatively
|
0 units on a scale
Interval 0.0 to 0.5
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: daysPopulation: data lost in follow up
Outcome measures
| Measure |
TAP Block
n=26 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Time to Mobilization
|
1 days
Interval 0.5 to 2.0
|
1 days
Interval 0.5 to 2.0
|
SECONDARY outcome
Timeframe: daysPopulation: data lost on follow up
Outcome measures
| Measure |
TAP Block
n=24 Participants
Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
|
Local Anaesthetic Infiltration
n=28 Participants
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
|
|---|---|---|
|
Time to Hospital Discharge
|
4.5 days
Interval 3.0 to 9.0
|
4.5 days
Interval 3.0 to 8.0
|
Adverse Events
TAP Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Local Anaesthetic Infiltration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Nicholas Crabtree
Oxford University Hospitals NHS Trust
Phone: 01865 221590
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place