N/A
Completed N=79
Evaluation of a TAP Block Given During Laparoscopic Colorectal Surgery to Help Control Pain
Colorectal Disease
Source: ClinicalTrials.gov NCT01731782 ↗
Enrolled (actual)
79
Serious AEs
1.3%
Results posted
Nov 2022
Primary outcomePrimary: Postoperative Pain as Measured by Pain Score — 2.60; 3.46 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain as Measured by Pain Score |
2.60; 3.46 | — |
| SECONDARY Percent of Analgesics Used as Measured by Patient Report |
0.80; 1.79 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have benign or malignant colonic or rectal disease that are being scheduled for laparoscopic colorectal resection.
- Subjects who are 18 years of age and older
- Subjects of either sex
- 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
- 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.
- Subjects who are pregnant.
- Subjects with a medical condition that may interfere with the use of the study medication Bupivicaine.
- Subjects who have another condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
Data sourced from ClinicalTrials.gov (NCT01731782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.