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

December 29, 2016 updated by: washington aspilicueta pinto filho, Hospital Infantil Albert Sabin

Choose Between Two Different Concentration of Ropivacaine on TAP Block for Children Submitted of Open Appendectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ceara
      • Fortaleza, Ceara, Brazil, 60410794
        • Hospital Infantil Albert Sabin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Infantil Albert Sabin

Collaborators

Fortaleza University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 25, 2016

First Submitted That Met QC Criteria

December 25, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOSPITALIAS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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