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Effectiveness of a Quadratus Lumborum 3 Block vs. a TAP-block for Inguinal Hernia Repair (NCT03023462)

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 the a Quadratus Lumborum 3 Block with a long acting local anesthetic.
  • Drug: Oksykodonhydroklorid
    Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
    • oxycodone
  • Drug: Ketobemidone Hydrochloride
    In case of insufficient analgesia, judged by the patient.
    • Ketorax
  • Drug: Ondansetron and Droperidol
    When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
    • Ondansetron and Dridol
  • Drug: Ropivacaine
    Local anesthetic for the block
    Ages eligible for Study
    18 Years to 80 Years
    Genders eligible for Study
    Male
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Scheduled for general anaesthesia Laparoscopic inguinal hernia repair 20<BMI(Kg/sq.m.>35
    Exclusion Criteria:
    • Allergy to LA
    • Chronic pain requiring opioid analgesics
    • Patients with atrioventricular block II
    • Patients treated with class III antiarrhythmics
    • Patients with severe renal and/or hepatic disease
    • A coagulation disorder
    • An infection at the LA injection place
    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 a Quadratus Lumborum 3 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 Quadratus Lumborum 3 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:

    Differences in pain scores between the 2 groups until 48 hours after the operation.

    The secondary endpoints:

    - Pain at the incision site

    - Deep pain and pain on coughing

    - Nonsteroidal anti-inflammatory drug consumption

    - Postoperative nausea and vomiting

    - Antiemetics administered

    - Sedation scores Power and Sample Size Calculator The number of patients required for the study was calculated on the basis of VAS, which was found to be 22±12 mm in Peterson PL study (Petersen, et al. 2013 (30):7). We were interested in a reduction by 20% in the group given IFB. Assuming α=0,05, we calculated that we need 46 patients (23 in each group) to achieve a power of 80% (β=0.2).

    50 adult patients have to be scheduled for primary inguinal hernia repair includes.

    The study is randomized:

    - Group QLB: Quadratus Lumborum 3 Block using ropivacaine 7,5 mg/ml, 30ml

    - Group TAP: Transversus abdominis plane block, 20 ml of ropivacaine 7,5 mg/ml and inguinal field blocks.

    Subcutaneous wound infiltration in all patients with ropivacaine 5 mg/ml, 5-10 ml.

    Premedication: Paracetamol 2g General anaesthesia: TCI (Target Control Infusion = Anesthesia protocol): Propofol and Remifentanil Surgical procedure: Inguinal hernia repair

    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, ketobemidone 1 mg IV.

    - 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.

    Collected data:

    - Postoperative pain at rest and during activity evaluates by 100-mm visual analog scale (VAS) and 4-points verbal pain score (VPS; with no pain= =, slight pain = 1, Moderate pain = 2, and severe pain = 3) on admission to recovery, and every hour until discharge.

    - Rescue analgesic consumption during 0 to 4, 4 to 24 and 24 to 48 h.

    - Sedation, 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), antiemetics administered (0 to 24 and 24 to 48 H), grade of sedation (0 to 10 scale, where 0 = awake, and 10 = aroused on stimulation), and other side effects and symptoms of LA (Local Anesthetics) toxicity.

    Telephone interview at 24 h, 48 h and 7 days, with questions:

    - Pain during rest and activity using the VPS

    - Total need og analgesics

    - Sedation

    - Nausea

    - Level of activity

    - Overall satisfaction with the per- and postoperative period on a 0 - 3 scale: not satisfied, slight, moderate or highly satisfied.
    Status:
    not yet recruiting
    Type:
    Interventional
    Phase:
    Start:
    30 September, 2017
    Updated:
    28 September, 2017
    Participants:
    50
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