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Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT02494336
Recruitment Status : Active, not recruiting
First Posted : July 10, 2015
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nicole Chandler, Johns Hopkins All Children's Hospital

Brief 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 PACU staff will be blinded to the method of analgesic administration.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Trans-incisional rectus sheath block Procedure: Laparoscopic guided rectus sheath block Drug: Ropivacaine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Trans-incisional Rectus Sheath Block Versus Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy: A Prospective, Randomized Study
Study Start Date : June 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Active Comparator: Trans-incisional rectus sheath block
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Procedure: Trans-incisional rectus sheath block
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.

Drug: Ropivacaine
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.

Active Comparator: Laparoscopic guided rectus sheath block
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Procedure: Laparoscopic guided rectus sheath block
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.

Drug: Ropivacaine
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.




Primary Outcome Measures :
  1. Post operative pain rating [ Time Frame: 5 days ]
    Using the Wong-Baker FACES Pain Rating Scale (WBFPRS)


Secondary Outcome Measures :
  1. Operative time [ Time Frame: 1 day ]
  2. Use of post-operative intravenous/oral opioid and non-opioid [ Time Frame: 5 days ]
  3. Time to first rescue analgesic [ Time Frame: 1 day ]
  4. Number of participants with side effects [ Time Frame: 5 days ]
    Such as nausea, vomiting, allergic reactions

  5. Number of participants with complications [ Time Frame: 30 days ]
    Complications such as infection, bleeding, intravascular injection, bowel puncture

  6. Number of complications [ Time Frame: 30 days ]
    Such as infection, bleeding, intravascular injection, bowel puncture



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 10-21 years old undergoing single-incision laparoscopic cholecystectomy

Exclusion Criteria:

  • Patients with choledocolithiasis, gallstone pancreatitis, or sickle cell disease
  • Allergy to bupivacaine
  • Concurrent surgical procedure
  • Developmental delay or neurologic diagnosis that would interfere with post- operative pain score assessment
  • Chronic pain medication use, chronic pain disorder or complex regional pain syndrome
  • Anesthesiologist classification of III or greater

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494336


Locations
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United States, Florida
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Sponsors and Collaborators
Johns Hopkins All Children's Hospital
Investigators
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Principal Investigator: Nicole M Chandler, MD Johns Hopkins All Children's Hospital

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Responsible Party: Nicole Chandler, Assistant Professor of Surgery, Johns Hopkins All Children's Hospital
ClinicalTrials.gov Identifier: NCT02494336     History of Changes
Other Study ID Numbers: 41111
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents