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

NCT03005808 | Completed Phase 4 DMC

• 1 other identifier: HOSPITALIAS1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Appendicitis

Keywords

appendectomy, pediatrics, nerve block, abdominal wall

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hour after surgery

Secondary Outcomes (1)

• Reduce the opioid consumption through 24 hours postoperative observation

  24 hour after surgery

Study Arms (3)

control group

NO INTERVENTION

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

TAP 0.25 group

EXPERIMENTAL

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

TAP 0.5 group

EXPERIMENTAL

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

Interventions

Ropivacaine DRUG

Surgery for appendicitis

Also known as: Appendectomy

TAP 0.25 group; TAP 0.5 group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.

Sponsors & Collaborators

• Hospital Infantil Albert Sabin: lead
• Fortaleza University: collaborator

Study Sites (1)

Hospital Infantil Albert Sabin

Fortaleza, Ceará, 60410794, Brazil

Location

Related Publications (4)

• 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.

  PMID: 27731956 BACKGROUND

• 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.

  PMID: 20802056 BACKGROUND

• 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.

  PMID: 25571981 BACKGROUND

• 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.

  PMID: 22488336 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Appendicitis

Interventions

Ropivacaine; Appendectomy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical Anesthesiologist

Study Record Dates

• First Submitted: December 25, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)