Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This is a prospective, double-blinded, randomized controlled study comparing the efficacy of
      trans-incisional rectus sheath block to laparoscopic guided rectus sheath block for pediatric
      single-incision laparoscopic cholecystectomy (SILC). umbilical hernia repair in children.

      Patients aged 10-21 years old undergoing SILC for cholelithiasis, cholecystitis, or biliary
      dyskinesia will be screened for study inclusion. Eligible patients and their
      parents/guardians will be approached and, if agreeable, consented for the study
      pre-operatively. Patients will be randomized to receive either trans-incisional rectus sheath
      block or intra-operative rectus sheath block under direct laparoscopic visualization. Both
      will be done by the attending pediatric surgeon. The patient, patient guardians, select
      research team members, and Post anesthesia care unit (PACU) staff will be blinded to the
      method of analgesic administration.
    

Detailed description: 
      Regional anesthesia has been increasingly utilized for providing post-operative analgesia for
      a number of surgical procedures in children. Rectus sheath block and local anesthetic
      infiltration of the surgical site are two common modes for providing post-operative
      analgesia. Studies comparing the two modes have shown ultrasound-guided rectus sheath block
      to improve immediate pain scores and reduce use of post-operative analgesia in pediatric
      patients undergoing umbilical hernia repair. However, these studies have compared
      pre-incisional ultrasound-guided rectus sheath block to post-operative local anesthetic
      infiltration as a subcutaneous and/or intradermal injection. Also, to our knowledge, there
      are no studies evaluating the use or efficacy of laparoscopic guided rectus sheath block for
      pediatric single-incision laparoscopic surgery. Single-incision surgery involves performing
      abdominal operations though a single, small incision, usually located at the umbilicus.

      The purpose of this study is to compare the efficacy of trans-incisional rectus sheath block
      to intra-operative infiltration of the rectus sheath under direct laparoscopic visualization
      via an intra-abdominal approach for providing post-operative analgesia following
      single-incision laparoscopic cholecystectomy (SILC) in children.

      The investigators propose a prospective study where pediatric patients who are undergoing
      single-incision laparoscopic cholecystectomy will be randomized pre-operatively to receive
      either a trans-incisional rectus sheath block after facial closure but prior to skin closure
      or intra-operative infiltration of the rectus sheath under direct laparoscopic visualization
      after cholecystectomy. The primary outcome is the post-operative pain rating based on the
      Wong-Baker Faces Pain Rating Scale (WBFPRS) following SILC. Additional outcomes measured will
      include: operative times, the use of intravenous/oral opioid and/or non-opioid medication in
      the post-operative period, duration of analgesia following surgery based on time to first
      rescue analgesic, intra-operative hemodynamic changes, post-operative hemodynamic changes,
      incidence of side-effects, and complications. Patients/patient guardians will receive a sheet
      to document post-operative WBFPRS scores, oral opioid and non-opioid medication
      administration once discharged to home for a total of 5 days.
    

Intervention name(s): Trans-incisional rectus sheath block; Laparoscopic guided rectus sheath block; Ropivacaine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.; After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.; Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care