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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005808
• Other study ID #: HOSPITALIAS1
• Status: Completed
• Phase: Phase 4
• First received: December 25, 2016
• Last updated: December 29, 2016
• Start date: January 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Hospital Infantil Albert Sabin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine
Surgery for appendicitis

Locations

Country	Name	City	State
Brazil	Hospital Infantil Albert Sabin	Fortaleza	Ceara

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Infantil Albert Sabin	Fortaleza University

Country where clinical trial is conducted

Brazil, 

References & 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. — View 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. — View 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. — View Citation

Reinoso-Barbero F, Población 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	24 hour after surgery	Yes