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

Primary Purpose

Pain, Postoperative, Appendicitis

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Hospital Infantil Albert Sabin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring appendectomy, pediatrics, nerve block, abdominal wall

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Infantil Albert Sabin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

TAP 0.25 group

TAP 0.5 group

Arm Description

All patients had the same protocol of anesthesia and analgesia. The control group didn´t received block.

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.

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.

Outcomes

Primary Outcome Measures

Reduce the pain intensity using the Face Pain Scale
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

Reduce the opioid consumption through 24 hours postoperative observation
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.

Full Information

First Posted
December 25, 2016
Last Updated
December 29, 2016
Sponsor
Hospital Infantil Albert Sabin
Collaborators
Fortaleza University
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1. Study Identification

Unique Protocol Identification Number
NCT03005808
Brief Title
Choose the Best Concentration of Ropivacaine on TAP Block for Open Appendectomy in Children
Official Title
Choose Between Two Different Concentration of Ropivacaine on TAP Block for Children Submitted of Open Appendectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Infantil Albert Sabin
Collaborators
Fortaleza University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Appendicitis
Keywords
appendectomy, pediatrics, nerve block, abdominal wall

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
All patients had the same protocol of anesthesia and analgesia. The control group didn´t received block.
Arm Title
TAP 0.25 group
Arm Type
Experimental
Arm Description
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.
Arm Title
TAP 0.5 group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Appendectomy
Intervention Description
Surgery for appendicitis
Primary Outcome Measure Information:
Title
Reduce the pain intensity using the Face Pain Scale
Description
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.
Time Frame
24 hour after surgery
Secondary Outcome Measure Information:
Title
Reduce the opioid consumption through 24 hours postoperative observation
Description
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.
Time Frame
24 hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Hospital Infantil Albert Sabin
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60410794
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27731956
Citation
Abu Elyazed MM, Mostafa SF, Abdullah MA, Eid GM. The effect of ultrasound-guided transversus abdominis plane (TAP) block on postoperative analgesia and neuroendocrine stress response in pediatric patients undergoing elective open inguinal hernia repair. Paediatr Anaesth. 2016 Dec;26(12):1165-1171. doi: 10.1111/pan.12999. Epub 2016 Oct 12.
Results Reference
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PubMed Identifier
20802056
Citation
Carney J, Finnerty O, Rauf J, Curley G, McDonnell JG, Laffey JG. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial. Anesth Analg. 2010 Oct;111(4):998-1003. doi: 10.1213/ANE.0b013e3181ee7bba. Epub 2010 Aug 27.
Results Reference
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PubMed Identifier
25571981
Citation
Lapmahapaisan S, Tantemsapya N, Aroonpruksakul N, Maisat W, Suraseranivongse S. Efficacy of surgical transversus abdominis plane block for postoperative pain relief following abdominal surgery in pediatric patients. Paediatr Anaesth. 2015 Jun;25(6):614-20. doi: 10.1111/pan.12607. Epub 2015 Jan 9.
Results Reference
background
PubMed Identifier
22488336
Citation
Reinoso-Barbero F, Poblacion G, Builes LM, Castro LE, Lahoz AI. Successful ultrasound guidance for transversus abdominis plane blocks improves postoperative analgesia after open appendicectomy in children. Eur J Anaesthesiol. 2012 Aug;29(8):402-4. doi: 10.1097/EJA.0b013e328353570e. No abstract available.
Results Reference
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Choose the Best Concentration of Ropivacaine on TAP Block for Open Appendectomy in Children

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