Choose Between Two Different Concentration of Ropivacaine on TAP Block for Children Submitted of Open Appendectomy
| Registry | NCT03005808 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | Hospital Infantil Albert Sabin (Other); collaborators: Fortaleza University |
| Conditions | Pain, Postoperative, Appendicitis |
| Interventions | Ropivacaine (Drug) |
| Dates | start 2015-01-01, primary completion 2016-02-01, completion 2016-11-01, first posted 2016-12-29, last updated 2016-12-30 |
| Locations | 1 site in Brazil |
Related Papers Related Patents Related Grants Related Experts
All trials for Pain, Postoperative All trials for Appendicitis All trials of Ropivacaine
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 | Drug: Ropivacaine | 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. |
| TAP 0.5 group | Experimental | Drug: Ropivacaine | 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. |
Sex: All, ages: 6 Years to 16 Years, 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Infantil Albert Sabin | Fortaleza, Ceará | Brazil |