The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy
Condition: Cholecystectomy; Quadratus Lumborum Block
Study type: Interventional

Summary: 
      The enhanced recovery after surgery and laparoscopic approach is essential after day-case
      surgery. The patients want to go home early without pain and nausea, and the hospitals need
      the post-operative capacity for more patients. Many patients have pains, nausea and vomiting
      postoperatively. Postoperative pain is an expected but undesirable effect after an operation.
      The aim of the study is to find out if a bilateral quadratus lumborum block has a beneficial
      effect after a cholecystectomy.
    

Detailed description: 
      QLB (quadratus lumborum block) is a recommended multimodal method of reducing postoperative
      pain in laparoscopic and open surgery. Quadratus lumborum block for postoperative pain after
      caesarean section 2015). Transversus abdominis plane (TAP) block seems to be feasible and
      effective in postoperative pain control without increasing morbidity in cholecystectomy. QLB
      is also performed as one of the perioperative pain management procedures in abdominal
      surgery. It is regarded as an effective analgesic tool The dermatomal effects of QLB reach
      higher than the TAP block and might explain the better effect of the QLB than TAP blocks on
      postoperative pain after caesarean delivery. A randomized double blinded clinical trial with
      TAP block in patients scheduled for cholecystectomy is performed, but there is no good data
      for the QLB. For this study the investigators standardize the type of surgery to be
      laparoscopic day-case cholecystectomy, and we use the anterior (transmuscular) QLB.

      Power and Sample Size Calculator The number of patients required for the study was calculated
      on the basis of opioid consumption. The investigators are interested in a reduction by 20% in
      the group given QLB. Assuming α=0,05, the calculation shows a need of 69 patients (23 in each
      group) to achieve a power of 80% (β=0.2).

      75 adult patients scheduled for cholecystectomy have to be included. Subcutaneous wound
      infiltration at the end of surgery in all patients with ropivacaine 2 mg/ml, 10 ml. Maximum
      allowed dosis is 3 mg/kg BW (BodyWeight). Dosis reduction if BW<70 kg. All three groups
      receive necessary analgesics oral or parenteral.

      Premedication: Paracetamol 2g and Diklofenak 100 mg

      General anesthesia: TCI (Target Control of Infusion): Propofol and Remifentanil, Ondansetron
      4 mg and Decadron 8 mg iv preoperatively. Oxycodon 5 mg iv at the end of the procedure.

      Surgical procedure: Cholecystectomy, laparoscopic and day-case.

      Postoperatively:

        -  Oral paracetamol and codeine-fixed combination up to 1000 mg and 60 mg, respectively,
           every 6 h

        -  In case of insufficient analgesia, as judged by the patient, oxycodon 1 - 5 mg IV.

        -  When nausea and vomiting occur postoperatively, ondansetron 4 mg IV administers as the
           drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.

      Collected data:

        -  Postoperative pain at rest and during activity evaluates by a 0 - 10 scale (NRS) on
           admission to recovery, and every hour until discharge.

        -  Rescue analgesic consumption during 0 to 4, 4 to 24 and 24 to 48 h.

        -  Nausea and vomiting record by the same 0 - 3 scale (none, slight, moderate, strong)
           during recovery

        -  Time of postoperative mobilization with corresponding pain score.

        -  Time of discharge-to-home readiness according to standard criteria, including stable
           vital signs, no bleeding from the surgical site, ability to void, absence of excessive
           nausea and pain, and ability to dress and walk without support.

        -  Side effects including nausea and/or vomiting (0 to 4, 4 to 24, and 24 to 48 h), and
           other side effects and symptoms of LA (Local Anaesthetic) toxicity.

      Telephone interview at 24 h and 48 h
    

Intervention name(s): Cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic technique
Other intervention name(s): Quadratus lumborum block with Naropin; Quadratus lumborum block with Nacl; Traditional analgesics
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment