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Evaluation of a TAP Block Given During Laparoscopic Colorectal Surgery to Help Control Pain

Evaluation of a TAP Block as Part of an Enhanced Recovery Pathway in Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-blinded Multi-institution Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01731782
Acronym
TAP Block
Enrollment
79
Registered
2012-11-22
Start date
2012-07-31
Completion date
2014-08-31
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Disease

Keywords

colorectal surgery

Brief summary

Patients experience pain after surgery mostly from their abdominal wounds, even when those wounds are small. Decreasing that pain has many benefits. It improves comfort, decreases stress response and might improve the outcome of the surgery. Local anesthesia (which is a numbing agent given directly at the site of pain via a needle) is given to decrease the pain that is felt after surgery and decrease the need for strong pain medications which can have negative side effects. One promising way to give local pain medication is called the transversus abdominis plane or TAP block. This method works by directly blocking the nerves in the abdomen that are the cause of the pain patients feel in their incision after surgery. This is done by injecting a numbing agent (Bupivacaine) into the area of their abdomen where their nerves are located that cause pain. In the case of nerves that carry sensation, bupivacaine blocks the pain sensation traveling in a particular nerve. Patients will be randomized (like a flip of a coin) to receive either a normal saline injection or the bupivacaine injection. The purpose of this study will be to prove the effectiveness of local anesthetic given via a TAP block in improving postoperative pain, decreasing the use of pain medications, decreasing postoperative nausea and vomiting and improve surgical outcomes such as hospital length of stay in laparoscopic colorectal surgery.

Detailed description

Using standard surgical procedures, the surgeon will proceed with the planned laparoscopic surgery. All procedures will be done by straight laparoscopic technique according to standard of care. At the completion of the procedure, and under laparoscopic control, patients will have a TAP block placed by the attending surgeon. The clinical research nurse involved in the research will prep the solution to be injected and the surgeon will be blinded as to whether the patient will be receiving normal saline or Marcaine in the TAP blocks. The block will be administered between the costal margin and iliac crest in the anterior axillary line. A Braun Stimuplex A insulated needle (80 mm 21 gauge) with 0.5 mL/kg solution (max of 30 ml) is passed through the skin, and then continued until two distinct pops are felt, which indicates the needle piercing each of the two fascial layers. The needle is then deemed to be in the inter-muscular plane between internal oblique and transversus abdominis muscles respectively, to target the spinal nerves in this plane. The laparoscope will be visualizing for the needle tip to ensure that it does not penetrate the peritoneum or inject pre-peritoneally. The local anesthetic is infiltrated in two separate injections into the same plane on each side. If a sub-peritoneal bleb is seen to be raised by the laparoscope, then the needle will be withdrawn slightly. Two thirds of the solution is injected, and the needle is withdrawn 5 mm and the remaining solution is injected. If injecting in the correct plane, then a smooth raised area of fluid, covered by transversus will be seen via the laparoscope. This procedure is repeated on the patients other side, to complete a bilateral block. Depending on their randomization, patients will receive one of the following solutions: Group A: Represents the control group and will receive 0.5 ml/kg of 0.9% normal saline for a maximum of 30 ml. Group B: Represents the experimental group and will receive 0.5 ml/kg of 0.25% Marcaine (bupivacaine) for a maximum of 30 ml.

Interventions

DRUGbupivacaine
DRUGnormal saline placebo (for bupivacaine)

Normal saline to mimic bupivacaine

Sponsors

University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Subjects who have benign or malignant colonic or rectal disease that are being scheduled for laparoscopic colorectal resection. 2. Subjects who are 18 years of age and older 3. Subjects of either sex 4. Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.

Exclusion criteria

1. Subjects who undergo conversion to the open approach will be excluded from the analysis, as the block will be given at the end of the procedure and is being evaluated for laparoscopic cases. 2. Subjects who are pregnant. 3. Subjects with a medical condition that may interfere with the use of the study medication Bupivicaine. 4. Subjects who have another condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain as Measured by Pain Scoreup to 10 daysPain measured via score of 1 to 5, with 1 being no pain and 5 being the worst pain

Secondary

MeasureTime frame
Percent of Analgesics Used as Measured by Patient ReportUp to 30 days after surgery

Other

MeasureTime frameDescription
Number of Nausea/Vomiting Episodesup to 10 days
Length of Hospital Stayup to 10 days
Day of Return of Bowel Functiondaily after surgery until discharge up to 10 daysLog the day bowel function returns by day postoperative that flatus returns and has first stool

Countries

United States

Participant flow

Participants by arm

ArmCount
Bupivacaine
bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml bupivacaine
41
Normal Saline
Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine
38
Total79

Baseline characteristics

CharacteristicBupivacaineNormal SalineTotal
Age, Continuous67.34 Years
STANDARD_DEVIATION 14.16
64.82 Years
STANDARD_DEVIATION 13.11
66.12 Years
STANDARD_DEVIATION 13.65
Sex: Female, Male
Female
23 Participants22 Participants45 Participants
Sex: Female, Male
Male
18 Participants16 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 38
other
Total, other adverse events
0 / 410 / 38
serious
Total, serious adverse events
1 / 410 / 38

Outcome results

Primary

Postoperative Pain as Measured by Pain Score

Pain measured via score of 1 to 5, with 1 being no pain and 5 being the worst pain

Time frame: up to 10 days

ArmMeasureValue (MEAN)Dispersion
BupivacainePostoperative Pain as Measured by Pain Score2.60 score on a scaleStandard Deviation 2.09
Normal SalinePostoperative Pain as Measured by Pain Score3.46 score on a scaleStandard Deviation 1.92
Secondary

Percent of Analgesics Used as Measured by Patient Report

Time frame: Up to 30 days after surgery

ArmMeasureValue (MEAN)Dispersion
BupivacainePercent of Analgesics Used as Measured by Patient Report0.80 percentage of analgesics usedStandard Deviation 0.52
Normal SalinePercent of Analgesics Used as Measured by Patient Report1.79 percentage of analgesics usedStandard Deviation 0.72
Other Pre-specified

Day of Return of Bowel Function

Log the day bowel function returns by day postoperative that flatus returns and has first stool

Time frame: daily after surgery until discharge up to 10 days

Other Pre-specified

Length of Hospital Stay

Time frame: up to 10 days

ArmMeasureValue (MEAN)Dispersion
BupivacaineLength of Hospital Stay3.15 daysStandard Deviation 2.03
Normal SalineLength of Hospital Stay2.87 daysStandard Deviation 1.58
Other Pre-specified

Number of Nausea/Vomiting Episodes

Time frame: up to 10 days

ArmMeasureValue (NUMBER)
BupivacaineNumber of Nausea/Vomiting Episodes10 Episodes
Normal SalineNumber of Nausea/Vomiting Episodes9 Episodes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026