Ignite Creation Date:
2024-05-06 @ 1:08 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01731782
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2012-10-19
Brief Title:
Evaluation of a TAP Block Given During Laparoscopic Colorectal Surgery to Help Control Pain
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
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
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAP Block
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
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 05 mLkg 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 05 mlkg of 09 normal saline for a maximum of 30 ml
Group B Represents the experimental group and will receive 05 mlkg of 025 Marcaine bupivacaine for a maximum of 30 ml
Group A Represents the control group and will receive 05 mlkg of 09 normal saline for a maximum of 30 ml
Group B Represents the experimental group and will receive 05 mlkg of 025 Marcaine bupivacaine for a maximum of 30 ml
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None