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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

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.

Condition or disease Intervention/treatment Phase
Appendicitis Procedure: UGBRSB Procedure: Local Infiltration Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Ultrasound Guided Bilateral Rectus Sheath Block and Local Anesthetic Infiltration for Postoperative Pain Control in Children With Acute Appendicitis
Study Start Date : April 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. Comparing the amount of morphine used during the first 48 hurs after surgery [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Comparing pain scores during the first 48 hours after surgery [ Time Frame: 48 hours ]
  2. Comparing time to first rescue analgesia [ Time Frame: 48 hours ]
  3. Comparing rescue analgesia used in the Post Anesthetic Care Unit (PACU) [ Time Frame: 48 hours ]
  4. Comparing incidence of side effects of opioids such as respiratory depression, itching, nausea, and vomiting, dysphoria [ Time Frame: 48 hours ]
  5. Comparing time to achieving discharge readiness in PACU [ Time Frame: 48 hours ]
  6. Comparing time to achieving discharge rediness from the hospital [ Time Frame: 48 hours ]
  7. comparing patient and parental satisfaction with pain management [ Time Frame: 48 hours ]


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02352519


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Yang Liu, M.D> Baylor College of Medicine
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Responsible Party: Yang Liu, Pediatric Anesthesiologist, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02352519    
Other Study ID Numbers: H28183
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents