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

NCT ID: NCT03005808

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Appendicitis

Keywords

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appendectomy, pediatrics, nerve block, abdominal wall

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Surgery for appendicitis

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.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Surgery for appendicitis

Interventions

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Ropivacaine

Surgery for appendicitis

Intervention Type DRUG

Other Intervention Names

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Appendectomy

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fortaleza University

OTHER

Sponsor Role collaborator

Hospital Infantil Albert Sabin

OTHER

Sponsor Role lead

Responsible Party

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washington aspilicueta pinto filho

medical Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Infantil Albert Sabin

Fortaleza, Ceará, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 27731956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20802056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25571981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22488336 (View on PubMed)

Other Identifiers

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HOSPITALIAS1

Identifier Type: -

Identifier Source: org_study_id