Laparoscopic vs Ultrasound Guided TAP Block in Colorectal Surgery. A Randomised Controlled Study.
Condition: Laparoscopic Surgical Procedure; Nerve Block
Study type: Interventional

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.
    

Detailed description: 
      At Danderyds hospital in Stockholm, since 2010, we are conducting patient care according to
      international evidence based Enhanced Recovery After Surgery (ERAS) protocols. Within
      colorectal surgery Danderyds hospital has been appointed ERAS Centre of Excellence due to
      documented favorable clinical results and a particularly suitable infrastructure for clinical
      research. The protocol comprises of 24 evidence-based interventions aimed at reducing so
      called surgical stress and promote early recovery after surgery. All interventions are
      executed in the same way for all patients. Optimal post-operative pain relief constitutes one
      of the 24 interventions and within this section a few methods are recommended. Transversus
      abdominus plane (TAP) block is one of those, and have been shown to reduce post-operative
      pain, reduce opioid consumption and elevate mobilization after surgery.

      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
    

Intervention name(s): LAPTAP
Intervention type(s): Procedure
Intervention description(s): Laparoscopic guided Transverse Abdominus Plane block
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial. The participants are during surgery randomized to either Laparoscopic guided TAP block or Ultrasound guided TAP block.
Masking: Single (Participant)
Primary purpose: Supportive Care