Analgesic Effect of TAP Block After Laparoscopic Cholecystectomy
Condition: Laparoscopic Cholecystectomy; Postoperative Analgesia
Study type: Interventional

Summary: 
      TAP block is a locoregional analgesic technique that consists of infiltrating a local
      anesthetic solution between the muscle layers of the abdominal wall. This block produces
      prolonged parietal analgesia.

      The aim of the study is to evaluate whether infiltration of the abdominal wall using TAP
      block reduces postoperative pain and postoperative analgesic consumption, and improves
      patient comfort after laparoscopic cholecystectomy. This effect will be clinically relevant
      only if parietal pain predominates postoperatively.
    

Detailed description: 
      Between 10 and 20% of the Western population suffer from gallstones. When a surgical
      operation (cholecystectomy) is necessary, the removal of the gallbladder is done by
      laparoscopy in 95% of cases. The risk of having to undergo this operation increases with age
      and on average women are twice as likely as men to have to undergo surgery. In Belgium, only
      4% of these laparoscopic cholecystectomies are performed as one day hospitalization. Although
      this operation is considered a minor surgery, patients sometimes report intense postoperative
      pain that may encourage them to spend a night in the hospital. Better management of
      postoperative pain could increase the number of outpatient procedures. A large individual
      variability in pain intensity is observed after this surgical procedure. Three types of pain
      can be associated with this surgery: parietal pain secondary to the incisions of the wall
      necessary for the introduction of the surgical instruments; deep visceral pain, difficult to
      localize and secondary to surgical trauma in the area of dissection of the gall bladder; and
      scapular pain, a projected pain secondary to the irritation of the diaphragm by
      CO2-pneumoperitoneum. The temporal characteristics and intensity of these three types of pain
      are different. Some report a predominance of parietal pain, while for others visceral pain is
      most intense.

      The Transversus Abdominis Plane (TAP) block is a loco-regional analgesia technique that
      consists of infiltrating a local anesthetic solution between the plane of the transversus
      abdominis muscle and the internal oblicus muscle, laterally at the level of the triangle of
      Petit. The sensory nerves of the abdominal wall pass through this plane. This technique
      produces long-lasting analgesia, between 24-36 hours. Only the nerves responsible for the
      innervation of the abdominal wall are blocked by this infiltration. The metameric extension
      of parietal analgesia varies from one study to another, especially depending on the site of
      infiltration. After posterior TAP block, parietal analgesia concerns the infra-umbilical
      abdominal wall, but can reach in some cases the dermatome T-8. When the surgery involves the
      supra-umbilical abdominal wall, the TAP block is performed at the subcostal level to block
      the nerve branches T-6 to T-10. Infiltration is then performed between the transverse muscle
      and the rectus abdominis at the lateral end of this muscle.

      Several studies have evaluated the efficacy of TAP block for analgesia after laparoscopic
      cholecystectomy. Controversial results have been reported. These controversies can be
      explained in part by the type of TAP block used: lateral versus subcostal approach which
      appears more appropriate for laparoscopic cholecystectomy (supra-umbilical parietal
      incisions). In addition, effective multimodal analgesia, a recommended good medical practice,
      is not always used in these studies. This strategy, by effectively reducing postoperative
      pain, may make the clinical utility of TAP block irrelevant. Finally, in case of predominance
      of parietal pain on visceral pain, the clinical relevance of the TAP block should be
      objectified. In the opposite case (predominance of visceral pain), TAP block would be much
      less effective.

      2.2 Purpose of the study. The purpose of this study is to evaluate the analgesic efficacy of
      TAP subcostal block after laparoscopic cholecystectomy. The effectiveness of the TAP block
      will confirm the importance of the parietal pain component after this type of surgery.
      Decreases in postoperative pain and postoperative opioid consumption, possibly associated
      with a decrease in morphine side effects (nausea, vomiting, sedation, fatigue), may be
      conducive to the development of outpatient laparoscopic cholecystectomy.

      2.3 General description. This randomized double-blind placebo-controlled study will include
      two groups of 20 patients: the TAP block will be performed in a group using a local
      anesthetic solution (levobupivacaine [Chirocaine®] 0.375% Adr 1/200000) in the " treatment "
      group and with saline Adr 1/200000 in the control group.
    

Intervention name(s): Bilateral subcostal TAP block
Intervention type(s): Procedure
Intervention description(s): Echo-guided infiltration of a local anesthetic solution in the plane located between the transversus abdominis muscle and the rectus abdominis muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups : treatment group (TAP block with local anesthestic) compared to control group (TAP block with saline)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: surgery: laparoscopic cholecystectomy; analgesia: postoperative; locoregional analgesia: transversus abdominis plane block; opioid: side effects