Laparoscopic vs Ultrasound Guided TAP Block in Colorectal Surgery. A Randomised Controlled Study.

NCT04907461 | Completed

• 1 other identifier: LAPTAP Study
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial aiming to compare two different techniques of performing a nerve blockage of the abdominal wall. When performing surgery on the colon and rectum surgeons often use a minimal invasive technique called Laparoscopic surgery. In this technique small incisions in the abdominal wall are used to put special ports trough into the abdomen so that surgical instrument can be inserted. To minimize the pain caused by these port-holes, a so-called Transversus Abdominus Plane (TAP) nerve block is performed directly after the surgery before the patient wakes up from narcosis. 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.

Conditions

Laparoscopic Surgical Procedure; Nerve Block

Outcome Measures

Primary Outcomes (2)

• Post operative consumption of pain medication

  Difference in pain medication consumption between arms.

  72 hours post surgery

• Visual Analog Scale

  Difference in experienced post operative pain using Visual Analog Scale (VAS) between arms. The VAS pain scale reaches from 0-10 where 0 equals No pain and 10 equals maximum pain.

  72 hours post surgery

Secondary Outcomes (1)

• TAP procedure time

  TAP procedure during surgery

Study Arms (2)

Laparoscopic guided TAP block

EXPERIMENTAL

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.

Procedure: LAPTAP

Ultrasound guided TAP block

ACTIVE COMPARATOR

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.

Procedure: LAPTAP

Interventions

LAPTAP PROCEDURE

Laparoscopic guided Transverse Abdominus Plane block

Laparoscopic guided TAP block; Ultrasound guided TAP block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective laparoscopic or robot-assisted colorectal surgery.

You may not qualify if:

• IBD
• 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.

Sponsors & Collaborators

• Danderyd Hospital: lead

Study Sites (1)

Danderyd Hospital

Stockholm, 18150, Sweden

Location

Related Publications (14)

• 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.

  PMID: 30426190 BACKGROUND

• 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.

  PMID: 23099039 BACKGROUND

• 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.

  PMID: 19841366 BACKGROUND

• 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.

  PMID: 27451874 BACKGROUND

• 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.

  PMID: 25285696 BACKGROUND

• 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.

  PMID: 23355160 BACKGROUND

• 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.

  PMID: 25442068 BACKGROUND

• 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.

  PMID: 27896461 BACKGROUND

• 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.

  PMID: 23389068 BACKGROUND

• 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.

  PMID: 11576144 BACKGROUND

• 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.

  PMID: 28472015 BACKGROUND

• 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.

  PMID: 30540660 BACKGROUND

• 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.

  PMID: 31485929 BACKGROUND

• 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.

  PMID: 22041649 BACKGROUND

Study Officials

• Klas Pekkari, PhD, MD

  Danderyds Hospital, Karolinska Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are under narcosis during randomisation and intervention. The surgical staff are aware of randomisation and intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial. The participants are during surgery randomized to either Laparoscopic guided TAP block or Ultrasound guided TAP block.

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: May 31, 2021
• Primary Completion: May 20, 2023
• Study Completion: July 24, 2023
• Last Updated: February 1, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)