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

NCT02439281 | Terminated Results DMC

• 1 other identifier: PRO14100075
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Ropivacaine; Anesthesia adjuncts; clonidine; laparoscopic appendectomy; rectus sheath block

Outcome Measures

Primary Outcomes (1)

• Duration of Sensory Block (Paresthesia)

  The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine result in longer duration of sensory block (paresthesia) compared to ropivacaine alone.

  Indicated by return of normal sensation (expected average of 12 hours after block placement).

Secondary Outcomes (6)

• Satisfaction With Pain Control From Patient

  Prior to hospital discharge (up to 24 hours after surgery)

• Complications Rate

  until study completion

• Change in Anxiety Scores

  6 hours after block placement

• Duration of Analgesia at Umbilicus Instrument Site-How Many Minutes Passed From the Time When the Blocks Where Performed Until Patient Reported Pain at Umbilicus

  indicated by the first request for pain medication at umbilicus site

• Average Pain Severity at the Umbilicus Laparoscopic Site

  Logistic regression of the 4 th pain score assessment

Study Arms (2)

Ropivacaine Group

ACTIVE COMPARATOR

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Drug: Ropivacaine

Ropivacaine/ Clonidine Group

EXPERIMENTAL

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; Drug: Ropivacaine

Interventions

Clonidine DRUG

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

Also known as: kapvay, Catapres, Duraclon, Nexiclon

Ropivacaine/ Clonidine Group

Ropivacaine DRUG

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

Also known as: Naropin

Ropivacaine Group; Ropivacaine/ Clonidine Group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mihaela Visoiu: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15201, United States

Location

Related Publications (32)

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  PMID: 33752119 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Clonidine; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

I had to stop the study after 50 patients because the patients that underwent laparoscopic appendectomy were sent home on a day of surgery, before the numbness wore off.

Results Point of Contact

• Title: Mihaela Visoiu
• Organization: U Pittsbutgh, UPMC Children's Hospital

visoium@upmc.edu

4126925260

Study Officials

• Mihaela Visoiu, MD

  Children's Hospital of UPMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Acute Interventional Perioperative Pediatric Pain Service

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 8, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)