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

Hospital Infantil Albert Sabin

Status and phase: Completed; Phase 4

Conditions: Appendicitis; Pain, Postoperative

Treatments: Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03005808

HOSPITALIAS1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

control group

No Intervention group

Description:

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

TAP 0.25 group

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine

TAP 0.5 group

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine