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Completed

NCT Number: NCT03005808

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

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.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Infantil Albert Sabin

Fortaleza, Ceará, 60410794, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine

Drug

Surgery for appendicitis

Other names: Appendectomy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Infantil Albert Sabin

Other

Collaborators

  • Fortaleza University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2016
Registry last updated
Dec 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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