Laparoscopic vs Ultrasound Guided TAP Block in Colorectal Surgery. A Randomised Controlled Study.
NCT ID: NCT04907461
Last Updated: 2024-02-01
Study Results
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Basic Information
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COMPLETED
NA
175 participants
INTERVENTIONAL
2021-05-31
2023-07-24
Brief Summary
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This procedure is normally performed by the anesthesiologist using ultrasound to guide a needle to the right depth or "plane" in the abdominal wall where the nerves are gathered. When in the right position a local anesthetic is injected that will block the nerves and thereby anaesthetizing the abdominal wall for the first post-operative day.
Recently an alternative way of guiding the needle to the right position has been presented. By using a laparoscopic camera the surgeon can easily guide the needle and inject the local anesthetics during surgery. This way of performing the TAP block may save valuable time compared to the more cumbersome ultrasound guided technique while also not needing an extra anesthesiologist in the operating theater.
In this study we aim to include participants selected for elective minimal invasive surgery of the colon or rectum, where a TAP block is normally performed. The participant will be randomized to either a TAP block performed by the surgeon using laparoscopic guidance or by an anesthesiologist using ultrasound guidance. The intended surgery in itself will not be altered.
During surgery we will measure TAP procedure time, total surgical time, total duration of anesthesia and total time spent in the operating theater. The following 2 postoperative days we will measure experienced pain using a validated pain-score (VAS) and measure the total consumption of pain medication. 2 days after surgery the study ends for the participant and there is no further follow up.
By conducting this study we can determine whether a laparoscopic guided TAP by the surgeon, compared to a traditional ultrasound guided by the anesthesiologist; gives a shorter procedure time, shorter time of narcosis and reduced consumption of pain medications post-operative while still not affecting the experienced pain by the participant.
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Detailed Description
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A TAP block is performed by injecting local anesthetics into the nervous plane in between the transverse and external muscles in the abdominal wall, and thereby blocking the nerves responsible for transmitting pain from the laparoscopic holes created during surgery.
Normally this TAP blockage is performed by the anesthesiologist using ultrasound to guide the needle for injection into the right plane of the abdominal wall. A procedure that can be cumbersome and that in our hospital setting takes around 30 minutes and is executed directly after the surgery but before the patient is alleviated of narcosis.
A novel technique has recently been described to guide the needle into the right position for the TAP block. In this technique the surgeon will use the laparoscopic camera and the port holes already made during surgery to visualize the inside of the abdominal wall, and by landmarks and a specially described bulging of the peritoneum as a marker, guide the needle from the outside and inject local anesthetics into the right plane. This method described by earlier studies has a procedure time at around 5+-1 minutes and has the benefit of not needing ultrasound or any other equipment not already present for the surgical procedure.
In this study we aim to include participants selected for elective robotic-assisted or laparoscopic minimal invasive surgery of the colon or rectum, where a TAP block is normally performed. The participant will be randomized to either a TAP block performed by the surgeon using laparoscopic guidance or by an anesthesiologist using ultrasound guidance. The intended surgery in itself will not be altered.
During surgery we will measure TAP procedure time, total surgical time, total duration of anesthesia and total time spent in the operating theater.
The following 2 postoperative days we will measure experienced pain using Visual Analog Scale (VAS) and measure the total opioid consumption. 2 days after surgery the study ends for the participant and there is no further follow up.
Previous studies on this technique have shown comparable or even better pain relieving efficacy compared to the ultrasound guided technique.
By conducting this study we can determine whether a laparoscopic guided TAP by the surgeon, compared to a traditional ultrasound guided TAP by the anesthesiologist; gives a shorter procedure time, shorter time of narcosis and reduced consumption of pain medications post-operative while still not affecting the experienced pain by the participant
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Laparoscopic guided TAP block
The surgeon uses a laparoscopic technique to visualise the peritoneum from the inside of the abdomen and guides the hypodermic needle through the abdominal wall from the outside. When the needle point is visible through the peritoneum and almost enters the abdominal cavity, the surgeon retracts the needle around 5 mm. Then by deploying a test dose of the local anaesthetics a so called "Doyle's bulge" sign can confirm the right position in the nervous plane. A dose of 20 cc 3,75 mg/ml of Ropivacain is administered on each side of the abdominal wall in the midaxillary line, just in between the crista and costal margin.
LAPTAP
Laparoscopic guided Transverse Abdominus Plane block
Ultrasound guided TAP block
The anaesthesiologist uses ultrasound to identify the nervous plane in-between the external and transverse abdominal muscles. A dose of 20 cc 3,75 mg/ml of Ropivacain is administered on each side of the abdominal wall in the midaxillary line, just in between the crista and costal margin.
LAPTAP
Laparoscopic guided Transverse Abdominus Plane block
Interventions
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LAPTAP
Laparoscopic guided Transverse Abdominus Plane block
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* documented alcohol addiction
* documented opioid addiction
* unable to be assessed by Visual Analog Scale (cognitive impairment or other)
* Allergy against the local anaesthetic used, Ropivacain.
18 Years
85 Years
ALL
No
Sponsors
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Danderyd Hospital
OTHER
Responsible Party
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Principal Investigators
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Klas Pekkari, PhD, MD
Role: STUDY_DIRECTOR
Danderyds Hospital, Karolinska Institute
Locations
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Danderyd Hospital
Stockholm, , Sweden
Countries
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References
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Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.
Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
Keller DS, Madhoun N, Ponte-Moreno OI, Ibarra S, Haas EM. Transversus abdominis plane blocks: pilot of feasibility and the learning curve. J Surg Res. 2016 Jul;204(1):101-8. doi: 10.1016/j.jss.2016.04.012. Epub 2016 Apr 27.
Keller DS, Ermlich BO, Schiltz N, Champagne BJ, Reynolds HL Jr, Stein SL, Delaney CP. The effect of transversus abdominis plane blocks on postoperative pain in laparoscopic colorectal surgery: a prospective, randomized, double-blind trial. Dis Colon Rectum. 2014 Nov;57(11):1290-7. doi: 10.1097/DCR.0000000000000211.
Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2481-6. doi: 10.1007/s00464-012-2761-y. Epub 2013 Jan 26.
Keller DS, Ermlich BO, Delaney CP. Demonstrating the benefits of transversus abdominis plane blocks on patient outcomes in laparoscopic colorectal surgery: review of 200 consecutive cases. J Am Coll Surg. 2014 Dec;219(6):1143-8. doi: 10.1016/j.jamcollsurg.2014.08.011. Epub 2014 Sep 16.
Tikuisis R, Miliauskas P, Lukoseviciene V, Samalavicius N, Dulskas A, Zabuliene L, Zabulis V, Urboniene J. Transversus abdominis plane block for postoperative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial. Tech Coloproctol. 2016 Dec;20(12):835-844. doi: 10.1007/s10151-016-1550-3. Epub 2016 Nov 28.
Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.
Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
Ravichandran NT, Sistla SC, Kundra P, Ali SM, Dhanapal B, Galidevara I. Laparoscopic-assisted Tranversus Abdominis Plane (TAP) Block Versus Ultrasonography-guided Transversus Abdominis Plane Block in Postlaparoscopic Cholecystectomy Pain Relief: Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):228-232. doi: 10.1097/SLE.0000000000000405.
Zaghiyan KN, Mendelson BJ, Eng MR, Ovsepyan G, Mirocha JM, Fleshner P. Randomized Clinical Trial Comparing Laparoscopic Versus Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colorectal Surgery. Dis Colon Rectum. 2019 Feb;62(2):203-210. doi: 10.1097/DCR.0000000000001292.
Wong DJ, Curran T, Poylin VY, Cataldo TE. Surgeon-delivered laparoscopic transversus abdominis plane blocks are non-inferior to anesthesia-delivered ultrasound-guided transversus abdominis plane blocks: a blinded, randomized non-inferiority trial. Surg Endosc. 2020 Jul;34(7):3011-3019. doi: 10.1007/s00464-019-07097-y. Epub 2019 Sep 4.
Magee C, Clarke C, Lewis A. Laparoscopic TAP block for laparoscopic cholecystectomy: Description of a novel technique. Surgeon. 2011 Dec;9(6):352-3. doi: 10.1016/j.surge.2010.11.027. Epub 2010 Dec 24. No abstract available.
Other Identifiers
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LAPTAP Study
Identifier Type: -
Identifier Source: org_study_id
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