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Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination

NCT02439281 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-07-23

Study results available
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Summary

Background: Millions of pediatric patients undergo laparoscopic surgeries every year and many of them suffer significant pain and anxiety. Patient's anxiety correlates with the severity of pain and effective postoperative analgesia is necessary for optimal recovery. Single injections ultrasound guided rectus sheath blocks provide satisfactory postoperative analgesia after pediatric laparoscopic appendectomy, however they are short lived. Searching for a blocking agent that last long enough to outlast pain and has minimal side effects is a difficult task. Using a combination of drugs yielded mixed results. Few pediatric studies showed at best a weak trend in favor of clonidine prolonging analgesia after some blocks, but anxiolytic properties of clonidine were not investigated. This study will compare rectus sheath ropivacaine blocks with ropivacaine and clonidine blocks.

Methods: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be double blinded and randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location, and Ropivacaine Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg). Post-operative analgesia will be provided with ketorolac and acetaminophen around the clock, and morphine, or/and oxycodone as needed. The primary aim is to determine if ropivacaine combined with clonidine prolongs duration of paresthesia. The secondary aims are to determine if the use of clonidine decreases anxiety level, prolongs duration of analgesia, and decreases pain severity at umbilicus laparoscopic site, reduces the need for analgesics, improves satisfaction with pain control, and is associated with complications such as oversedation, hypotension, and bradycardia.

Conclusions: Every hour of excellent analgesia count and a prolongation of block duration by at least 50% is clinical relevant. The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine offer improved pain management compared to ropivacaine alone.

Conditions

  • Postoperative Pain

Interventions

DRUG

Clonidine

Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

DRUG

Ropivacaine

One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Sponsors & Collaborators

  • Mihaela Visoiu

    lead OTHER

Principal Investigators

  • Mihaela Visoiu, MD · Children's Hospital of UPMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-05-01
Completion
2018-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02439281 on ClinicalTrials.gov