Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
Condition: Inguinal Hernia; Pain, Postoperative
MeSH terms: Hernia; Pain, Postoperative; Hernia, Inguinal
Study type: Interventional

Summary: 
      One of the most common complications after hernia repair is postoperative and chronic pain.
      TAP (transverse abdominis plain) block is a recommended multimodal method of reducing
      postoperative pain in laparoscopic and open inguinal hernia repair. The objective of this
      study is to determine whether the use of a perioperative echo guided unilateral TAP block has
      a superior effect on postoperative pain after laparoscopic inguinal repair compared to an
      anterior Quadratus Lumborum Block with a long acting local anesthetic.
    

Detailed description: 
      One of the most common complications after hernia repair is postoperative and chronic pain.
      Postoperative pain is an expected but undesirable effect after an operation, which can result
      in an prolonged hospital stay or longer time to return fully to normal daily activities.
      There are indications that an insufficient treatment of postoperative pain is a risk factor
      for persistent or chronic pain after open and laparoscopic inguinal hernia repair (Berndsen
      FH 2007) (Nienhuijs SW 2005).

      TAP (transverse abdominis plain) block is a recommended multimodal method of reducing
      postoperative pain in laparoscopic and open surgery (El-Dawlatly AA 2009; 102). TAP block
      (Meyer A 2015) and an anterior Quadratus Lumborum Block (Adhikary, S.D. 2017) are both
      recommended for inguinal hernia repair. The objective of this study is to determine, whether
      the use of a perioperative echo guided unilateral TAP block has a superior effect on
      postoperative pain after laparoscopic inguinal repair compared to the anterior Quadratus
      Lumborum Block with a long acting local anesthetic. There will be no further analysis in this
      study regarding the evidence of open hernia inguinal repair and chronic pain.

      The primary endpoint:

      Opioid consumption measured in orale morphine equivalents four hours postoperative.

      The secondary endpoints:

      Opoioid consumption measured in orale morphine equivalents after 24 hours, 48 hours and seven
      days postoperative.

      Postoperative nausea and vomiting measured on a NRS scale 0-3 at timepoints 1,2,3 hours, 24
      hours, 48 hours and 7 days. Sedation scores measured on a NRS scale 0-3 at timepoints 1,2,3
      hours, 24 hours, 48 hours and 7 days. .

      There will be conducted a telephone interview by a blinded study nurse at 24 h, 48 h and 7
      days, interviewing the patients as to their NRS score, nausea, sedation, level of activity
      and satisfaction with their overall treatment.

      Power and Sample Size Calculator A pilot consisting of 12 patients was performed. The
      patients recieved a TAP block before a elective laparoscopic inguinal hernia repair. The mean
      oral morphine equivalents after four hours postoperative was 8.75 mg and the standard
      deviation 5.93 mg. With a significant clinical difference of 50%,an α = 0,05 and an effect
      size of 80% (β = 0,2) the total sample size is 60 patients with 30 patients in each group.

      Premedication: Paracetamol by weight (2 grams (g)>70 kilos (kg) <70 years, 1,5 g <70 kg >70
      years, 1 g <50 kg) , Diclofenac by weight (100 milligrams (mg) >70 kg <70 years, 50 mg <70 kg
      >70 years).

      General anaesthesia: TCI (Target Control Infusion = Anesthesia protocol): Propofol and
      Remifentanil Surgical procedure: Laparoscopic inguinal hernia repair. 5 mg/ml 10 ml
      Ropivacaine in the ports peroperatively.

      Postoperatively:

        -  Oral paracetamol 1000 mg every 6 h

        -  In case of insufficient analgesia (NRS≥4) oxycodon 2-5 mg will be administered by a
           postoperative nurse.

        -  When nausea and vomiting occurs postoperatively, ondansetron 4 mg IV administers as the
           drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.
    

Intervention name(s): Oksykodonhydroklorid; Ondansetron and Droperidol; Ropivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.; When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously; Local anesthetic for the block
Other intervention name(s): oxycodone; Ondansetron and Dridol
Intervention MeSH terms: Droperidol; Oxycodone; Ondansetron; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group QLB: Anterior Quadratus Lumborum Block using ropivacaine 7,5 mg/ml, 20ml. Subcutaneous wound infiltration in all patients with ropivacaine 5 mg/ml,10 ml.
Group TAP: Transversus abdominis plane block using ropivacaine 7,5 mg/ml, 20 ml Subcutaneous wound infiltration in all patients with ropivacaine 5 mg/ml,10 ml.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anterior Quadratus Lumborum block; Transversus Abdominis block; Truncal block