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

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ClinicalTrials.gov Identifier: NCT02439281
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Mihaela Visoiu, University of Pittsburgh

Brief 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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Clonidine Drug: Ropivacaine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ROPIVACAINE WITH CLONIDINE FOR PEDIATRIC RECTUS SHEATH BLOCKS- THE MAGIC COMBINATION? - A Double Blinded Prospective Study
Study Start Date : May 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ropivacaine Group
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
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
Other Name: Naropin

Experimental: Ropivacaine/ Clonidine Group
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Drug: Clonidine
Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Other Names:
  • kapvay
  • Catapres
  • Duraclon
  • Nexiclon

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
Other Name: Naropin




Primary Outcome Measures :
  1. Duration of sensory block (paresthesia) [ Time Frame: Indicated by return of normal sensation (expected average of 12 hours after block placement). ]
    The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine result in longer duration of sensory block (paresthesia) compared to ropivacaine alone.


Secondary Outcome Measures :
  1. Satisfaction with pain control [ Time Frame: Prior to hospital discharge (up to 24 hours after surgery) ]
    The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in better satisfaction with pain control.

  2. Complications rate [ Time Frame: up to 24 hours after surgery ]
    The investigators expect no difference in incidence of complications (e.g. oversedation, hypotension, bradycardia episodes, etc.).

  3. Change in anxiety scores [ Time Frame: Before surgery (baseline) and 6 hours after block placement ]
    The investigators hypothesize that patient postoperative anxiety scores are lower in the Ropivacaine/Clonidine group and postoperative anxiety scores decrease more in Ropivacaine /Clonidine Group, than in Ropivacaine Group.

  4. Duration of analgesia at umbilicus instrument site [ Time Frame: indicated by the first request for pain medication (expected average of 12 hours post block placement) ]
    The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in longer duration of analgesia and decreased pain scores compared to ropivacaine alone.

  5. Average pain severity at the umbilicus laparoscopic site [ Time Frame: 18 hours after surgery ]
    Scores will be obtained every 2 hours after PACU discharge up to 18 hours or until hospital discharge, whichever occurs first. The average of these scores will be evaluated.

  6. Medication Consumption [ Time Frame: 18 hours after surgery ]


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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 10-17 years
  • scheduled for elective laparoscopic appendectomy
  • weight >/=34kg
  • complete postoperative questionnaires.

Exclusion Criteria:

  • patients younger than 10 years and 18 years or older
  • weight < 34 kg
  • weight >/=100 kg
  • patient and family refusal
  • non-English-speaking patients and families
  • cognitive impairment
  • developmental delay
  • allergies to medications used in the study (hydromorphone, oxycodone, acetaminophen, ketorolac, ropivacaine, and clonidine)
  • need for opioids via patient controlled analgesia device
  • patients with a positive pregnancy test
  • local infection at planned injection sites
  • patients with failed rectus sheath blocks
  • patients that require opioids via patient controlled analgesia device
  • patients with laparoscopic procedure converted to open
  • patients that will not be able to place the time of return to normal sensation within 1 hour of its occurrence
  • patients with no follow up possible
  • the patients that will be discharged home before the resolution on paresthesia will be excluded from analysis of the first aim.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439281


Contacts
Contact: Mihaela Visoiu, MD 412-692-5260 visoium@upmc.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15201
Contact: Mihaela Visoiu, MD    412-692-5260    visoium@upmc.edu   
Principal Investigator: Mihaela Visoiu, MD         
Sponsors and Collaborators
Mihaela Visoiu
Investigators
Principal Investigator: Mihaela Visoiu, MD Children's Hospital of UPMC

Publications:
Spielberger Charles Donald ECD. State-trait Anxiety Inventory for Children: STAIC : How I Feel Questionnaire : Professional Manual 1973.

Responsible Party: Mihaela Visoiu, Director Acute Interventional Perioperative Pediatric Pain Service, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02439281     History of Changes
Other Study ID Numbers: PRO14100075
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mihaela Visoiu, University of Pittsburgh:
Ropivacaine
Anesthesia adjuncts
clonidine
laparoscopic appendectomy
rectus sheath block

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Clonidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action