Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Peripheral Nerve Block Versus Local Anesthetic
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in
      the postoperative period. As a routine part of the procedure, surgeons inject local
      anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most
      children will still require additional pain medications after surgery. The purpose of the
      study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal
      nerve) will give better pain relief, decreasing pain medication requirements and increasing
      comfort during the postoperative period.
    

Detailed description: 
      A study investigator who is not involved in the immediate care of the patient will use a
      computer generated randomized table as to whether a child undergoing laparoscopic
      appendectomy will receive local anesthetic infiltration to the laparoscopic port placement
      sites by the surgeon, or peripheral nerve blocks by the anesthesiologist. All subjects will
      receive a dose of fentanyl at 2 mcg/kg with a maximum dose of 100 mcg. If the subject is to
      get peripheral nerve blocks, the anesthesiologist will administer bilateral rectus sheath and
      ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia.
      The local anesthetic used will be 0.25% bupivacaine without epinephrine for both local
      infiltration and peripheral nerve blocks. It has been shown that a dose of 0.075 ml/kg is the
      minimum amount of local anesthetic needed for a successful block. This will be the dose for
      each block with a maximum of 3 ml for rectus sheath blocks, and 4 ml for ilioinguinal blocks
      adding up to a total maximum dose of 14 ml of 0.25% bupivacaine. The infiltration of port
      sites by surgeons will also be limited to a total of 14 ml. If a subject does not have
      adequate analgesia in the post anesthesia care unit (PACU), they may receive morphine 0.05
      mg/kg (max 2 mg) per dose; some may receive a dose of ketorolac 0.5 mg/kg (max 30 mg) per
      surgeon preference. A blinded observer will observe the subject for pain in the PACU using a
      validated pain scale, Faces Pain Scale - Revised (FPS-R). The need for additional pain
      medications will be noted by an observer in the PACU and followed for the first 24 hours
      postoperatively. All data will be entered in an Excel spreadsheet and the number of doses of
      rescue analgesics used will be used as the parameter to judge the efficacy of the peripheral
      nerve blocks versus local anesthetic infiltration.
    

Intervention name(s): Bupivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 3 ml for rectus sheath blocks and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml.; The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 14 ml.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: children; laparoscopic appendectomy; iliohypogastric nerve block; rectus sheath nerve block; ilioinguinal nerve block