Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair
Condition: Pain
MeSH terms: Hernia, Umbilical; Hernia; Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of local infiltration to an
      ultrasound guided nerve block placed by the anesthesiologist for children undergoing
      umbilical hernia repair.

      This is a double-cohort, double blinded, randomized study comparing local infiltration to
      ultrasound-guided rectus sheath block in children 1 to 17 years of age undergoing epigastric
      or umbilical hernia repair.

      We will first compare pain scores to see if one method is more adequate then the other in
      providing post-op analgesia. Our second aim is to compare morphine consumption between the
      two groups.

      Our third aim is to measure the levels of local anesthetic in the blood following local
      anesthetic infiltration or USGRSB.
    

Detailed description: 
      Healthy children, aged 1 to 17 years of age, undergoing elective umbilical hernia repairs
      will be considered for this study. After informed consent/assent has been obtained, the
      subject will be randomized into one of two groups. Group A will receive local infiltration of
      0.25% bupivacaine by the surgeon at the end of the subject's surgery. Group B will undergo an
      ultrasound-guided rectus sheath block using 0.25% bupivacaine prior to incision by an
      anesthesiologist skilled in the performance of this block.

      All subjects will receive a standardized anesthetic for their surgery. Subjects assigned to
      Group A (local infiltration) will receive 2mcg/kg of fentanyl prior to incision for
      intra-operative pain management. Subjects assigned to Group B will have their Rectus Sheath
      Block and no fentanyl will be given at this time.

      Fentanyl is a short-acting opioid analgesic. It's duration of action in the dose we will be
      using is approximately one hour which is close to the expected length of surgery. Therefore,
      it is not expected to influence the pain management after surgery.

      Pain scores will be assessed by a member of the research team. They will be blinded to which
      technique the subject has been randomized to. This person will not be involved in the direct
      care of the subject. These observations will be made using an age-appropriate scoring system
      (FLACC or FACES scale). Scoring will be done every 5 minutes when the subject is in the
      recovery room and every 30 minutes when they are in Phase II. This will be done until the
      subject is discharged from the hospital.

      Families will be followed by phone for 48 h post discharge, to collect data on medication
      use.
    

Intervention name(s): rectus sheath block; local anesthetic infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): ultrasound-guided rectus sheath block using 0.2ml/kg 0.25% bupivacaine bilaterally prior to skin incision; Wound infiltration using 0.4ml/kg 0.25% bupivacaine by the surgeon at the end of surgery
Other intervention name(s): bupivacaine; bupivacaine
Intervention MeSH terms: Bupivacaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain relief after umbilical hernia repair; morphine consumption; plasma bupivacaine levels