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A Comparison of UGBRS Block and Local Infiltration

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ClinicalTrials.gov Identifier: NCT02352519
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Yang Liu, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE July 24, 2014
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date July 21, 2015
Study Start Date  ICMJE April 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
Comparing the amount of morphine used during the first 48 hurs after surgery [ Time Frame: 48 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • Comparing pain scores during the first 48 hours after surgery [ Time Frame: 48 hours ]
  • Comparing time to first rescue analgesia [ Time Frame: 48 hours ]
  • Comparing rescue analgesia used in the Post Anesthetic Care Unit (PACU) [ Time Frame: 48 hours ]
  • Comparing incidence of side effects of opioids such as respiratory depression, itching, nausea, and vomiting, dysphoria [ Time Frame: 48 hours ]
  • Comparing time to achieving discharge readiness in PACU [ Time Frame: 48 hours ]
  • Comparing time to achieving discharge rediness from the hospital [ Time Frame: 48 hours ]
  • comparing patient and parental satisfaction with pain management [ Time Frame: 48 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of UGBRS Block and Local Infiltration
Official Title  ICMJE A Randomized Comparison of Ultrasound Guided Bilateral Rectus Sheath Block and Local Anesthetic Infiltration for Postoperative Pain Control in Children With Acute Appendicitis
Brief Summary In this research study, the investigators are trying to find out which of the two methods of injecting local anesthetics (at the site of the belly button cut or by ultrasound guided rectus sheath block) will provide better pain relief and less need for pain medication after surgery in children undergoing single incision laparoscopic appendectomy.
Detailed Description

Laparoscopic appendectomy is a common procedure in pediatric surgery. For single incision laparoscopic appendectomy (SILA), the laparoscope and other instruments are inserted with the aid of a large trocar through a single umbilical incision. Laparoscopic appendectomy via a single umbilical incision is a less invasive procedure associated with minimal or no scarring compared to the traditional laparoscopic operation. Postoperative pain, nausea and vomiting are common problems encountered with laparoscopic appendectomy and other abdominal operations. As an established standard practice at Texas Children's Hospital, pain control in these patients is achieved by intravenous opioids via a patient controlled device along with ketorolac tromethamine, as well as local anesthetic infiltration (LAI) performed by surgeon or bilateral rectus sheath blocks as described below.

The umbilical area is innervated by the bilateral 9th, 10th and 11th intercostal nerves, which run between the internal oblique and transversus abdominis muscle. At the lateral edge of the rectus muscle, the nerves perforate the rectus sheath and innervate the rectus muscle. Anterior cutaneous branches cross the muscle supplying the skin of the umbilical area. Successful blockade of the relevant intercostal nerves within the rectus sheath can provide effective pain relief for umbilical and other midline surgical incisions. Rectus sheath block has also been shown to give better pain control when compared with intra-incisional infiltration and intra-peritoneal injection in patients undergoing laparoscopic gynecologic surgery. Recently, it has been shown that there is improved efficacy and a decreased local anesthetic requirement when ultrasound is used to guide rectus sheath block in children undergoing umbilical hernia repair. However, data comparing pain after ultrasound guided bilateral rectus sheath block (UGBRSB) and peri-umbilical local anesthetic infiltration (LAI) for SILA are not available. The incidence of postoperative nausea and vomiting (PONV) is high after laparoscopic surgery, with a dose-related increase noted when opioids are used in the postoperative period. Effective regional anesthesia may decrease opioids use and consequently reduce the incidence of PONV and improve patient satisfaction.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Appendicitis
Intervention  ICMJE
  • Procedure: UGBRSB
    Under sterile conditions,the posterior rectus sheath will be identified by ultrasound, and an insulated 22 gauge 50 mm needle inserted till the tip is seen to be directly between the rectus abdominis muscle and the posterior rectus sheath. Bupivacaine 0.25% (0.2 ml/kg with maximum 5 ml in each side) will be injected observing the spread on the ultrasound image.
    Other Name: Ultrasound Guided Bilateral Rectus Sheath Block
  • Procedure: Local Infiltration
    In those patients randomized to the LAI group, the surgeon will perform infiltration of 0.5 ml/kg of 0.25% bupivacaine (maximum, 10 ml) around the incision
    Other Name: Local Anesthetic Infiltration
Study Arms  ICMJE
  • Experimental: UGBRSB
    Under sterile conditions,the posterior rectus sheath will be identified by ultrasound, and an insulated 22 gauge 50 mm needle inserted till the tip is seen to be directly between the rectus abdominis muscle and the posterior rectus sheath. Bupivacaine 0.25% (0.2 ml/kg with maximum 5 ml in each side) will be injected observing the spread on the ultrasound image.
    Intervention: Procedure: UGBRSB
  • Active Comparator: Local infiltration
    In those patients randomized to the LAI group, the surgeon will perform infiltration of 0.5 ml/kg of 0.25% bupivacaine (maximum, 10 ml) around the incision.
    Intervention: Procedure: Local Infiltration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2015)
80
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1) Acute appendicitis (2) Age 6 - 17 years (3) American Society of Anesthesiologists Physical Status I - III (4) Patients undergoing SILA procedure performed by a single pediatric surgeon (Dr. Ashwin P. Pimpalwar) (5) Patients judged by parents, physicians and other caretakers as being capable of using the patient controlled analgesia (PCA) device.

Exclusion Criteria:

  • 1) Patients who are not scheduled to undergo the procedure of SILA. (2) Patients with allergies to local anesthetics (3) Patients who do not understand or cannot use the pain rating scale because of developmental delay, language or other issues. (4) Patients with concomitant major cardio-respiratory disorders. (5) Patients judged to be incapable of using the PCA device (6) Patients who refuse to participate in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02352519
Other Study ID Numbers  ICMJE H28183
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yang Liu, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yang Liu, M.D> Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP