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Choose the Best Concentration of Ropivacaine on TAP Block for Open Appendectomy in Children

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ClinicalTrials.gov Identifier: NCT03005808
Recruitment Status : Completed
First Posted : December 29, 2016
Last Update Posted : December 30, 2016
Sponsor:
Collaborator:
Fortaleza University
Information provided by (Responsible Party):
washington aspilicueta pinto filho, Hospital Infantil Albert Sabin

Brief Summary:
Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall and the parietal peritoneum. The TAP block could advange the postoperative pain of Appendectomy in children. The world literature doesn´t focus the best Ropivacaine´s concentration to improve postoperative pain in Appendectomy in children. We propose a randomized trial that compares 3 groups children submitted Appendectomy in children between 6 and 16 years. The control group has received no blockade, the other two groups have received TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Appendicitis Drug: Ropivacaine Phase 4

Detailed Description:
Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall and the parietal peritoneum. The meta-analyzes in adults demonstrate improved of postoperative pain and analgesic´s consumption. There are few studies on TAP block in open appendectomies and laparoscopic in pediatrics, they show good results. There is a consensus of the best anesthetic volume for good infiltration of the TAP block, but there are still doubts in the literature about the best concentration of local anesthetics of long duration. The main objective of this prospective, randomly distributed and double-blind clinical trial is to evaluate two concentrations of 0.25% and 0.5% ropivacaine with a volume of 0.4 ml / kg in pain control and the analgesic consumption through 24 hours observation in open Appendectomy in children between 6 and 16 years. 3 groups were being compared: the control group has received no blockade, the other two groups have received TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg. All pacients patients received the same protocols (anesthesia and analgesia). The provided analgesia was dipyrone every 6 hours and ketoprofen every 8 hours, and rescue analgesia was tramadol every 4hours if it were required. The FACE pain scale was used to evaluate the postoperative pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Choose Between Two Different Concentration of Ropivacaine on TAP Block for Children Submitted of Open Appendectomy
Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
No Intervention: control group
All patients had the same protocol of anesthesia and analgesia. The control group didn´t received block.
Experimental: TAP 0.25 group
The TAP 0.25 group received TAP block with ropivacaine 0.25% 0.4ml/kg. All patients had the same protocol of anesthesia and analgesia.
Drug: Ropivacaine
Surgery for appendicitis
Other Name: Appendectomy

Experimental: TAP 0.5 group
The TAP 0.5 group received TAP block with ropivacaine 0.5% 0.4ml/kg. All patients had the same protocol of anesthesia and analgesia.
Drug: Ropivacaine
Surgery for appendicitis
Other Name: Appendectomy




Primary Outcome Measures :
  1. Reduce the pain intensity using the Face Pain Scale [ Time Frame: 24 hour after surgery ]
    Subjected to the same general anesthesia protocol and postoperative analgesia. The TAP0.25 and TAP0.5 groups received TAP block with ropivacaine 0.25% or 0.5% 0.4ml/kg, the control group didn´t receive block. The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of tramadol. The parents and the patients themselves were instructed to request analgesic at any time.


Secondary Outcome Measures :
  1. Reduce the opioid consumption through 24 hours postoperative observation [ Time Frame: 24 hour after surgery ]
    Subjected to the same general anesthesia protocol and analgesia. The TAP0.25 and TAP0.5 groups received TAP block with ropivacaine 0.25% or 0.5% 0.4ml/kg, the control group didn´t receive block. All patients received dipyrone and ketoprofen, the rescue analgesic used was tramadol 1.5mg / kg (maximum dose of 100mg) up to 4 / 4h when Face´s Scales reached 5 points.



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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children between 6 and 16 years who were previously healthy submitted to appendectomy.

Exclusion Criteria:

  • Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients 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): NCT03005808


Locations
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Brazil
Hospital Infantil Albert Sabin
Fortaleza, Ceara, Brazil, 60410794
Sponsors and Collaborators
Hospital Infantil Albert Sabin
Fortaleza University
Publications:
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Responsible Party: washington aspilicueta pinto filho, medical Anesthesiologist, Hospital Infantil Albert Sabin
ClinicalTrials.gov Identifier: NCT03005808    
Other Study ID Numbers: HOSPITALIAS1
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by washington aspilicueta pinto filho, Hospital Infantil Albert Sabin:
appendectomy, pediatrics, nerve block, abdominal wall
Additional relevant MeSH terms:
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Appendicitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents