ROPIVACAINE WITH CLONIDINE FOR PEDIATRIC RECTUS SHEATH BLOCKS- THE MAGIC COMBINATION? - A Double Blinded Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Duration of Sensory Block (Paresthesia)
Study Overview
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.
Detailed Description
Objective: The primary aim is to determine if ropivacaine combined with clonidine prolongs duration of paresthesia at the umbilicus. The secondary aims are to determine if the use of clonidine decreases anxiety level, prolongs duration of analgesia, decreases pain severity at the umbilicus laparoscopic site, reduces the need for pain medication, improves satisfaction with pain control, and is associated with complications such as oversedation, hypotension, and bradycardia.
Specific Aims: Aim 1 will determine if the duration of sensory block (paresthesia) after ultrasound guided single injections rectus sheath blocks performed with ropivacaine/ clonidine is longer than duration of paresthesia after rectus sheath blocks performed with ropivacaine alone. The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine result in longer duration of sensory block (paresthesia) compared to ropivacaine alone.
Aim 2 will determine if the use of clonidine decreases postoperative anxiety scores and if postoperative pain scores correlate with anxiety scores. 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 the Ropivacaine Group. The investigators expect that preoperative and postoperative Numeric Rating Scale(NRS) scores reported by the patient will correlate moderately (0.3-0.49) to high (equal /or >0.5) with preoperative and postoperative anxiety level.
Aim 3 will determine if rectus sheath injections with ropivacaine/ clonidine prolongs duration of analgesia at umbilicus instrument site, decreases analgesic consumption, improves satisfaction with pain control, and has minimal complications such as oversedation, bradycardia, and hypotension. The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in longer duration of analgesia compared to ropivacaine alone, lower pain scores at umbilicus, less need for pain medication consumption for pain at umbilicus and for the first 18 hours, better satisfaction with pain control from patient, parent and nurse. The investigators expect no difference in incidence of oversedation, hypotension, and bradycardia episodes.
Background: Millions of pediatric patients undergo laparoscopic surgeries every year and many of them suffer significant pain on the day of surgery and the subsequent days. Pain is a sensory and emotional experience, modified by multiple factors, including anxiety. Patient's anxiety correlates with the severity of pain. Children that are very anxious before surgery have been found to have more postoperative pain, delayed hospital discharge, higher incidence of emergence delirium, sleep disturbances, and other maladaptive behavior changes that can last up to a few weeks following surgery. Laparoscopic appendectomy can cause significant pain and anxiety despite the minimally invasive approach. The investigators' recent completed prospective study showed that on the day after surgery, pain after laparoscopic appendectomy correlated very well with postoperative anxiety scores (Pearson coefficient =0.539; pending publication results from 133 subjects, 11-17 years old, that underwent laparoscopic appendectomy).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ropivacaine Group
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Intervention: Ropivacaine (Drug)
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.
Intervention: Clonidine (Drug)
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.
Intervention: Ropivacaine (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Average Pain Severity at the Umbilicus Laparoscopic Site(Logistic regression of the 4 th pain score assessment)
- Satisfaction With Pain Control From Patient(Prior to hospital discharge (up to 24 hours after surgery))
- Complications Rate(until study completion)
- 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)
- Change in Anxiety Scores(6 hours after block placement)
- Medication Consumption(18 hours after surgery)
Investigators
Mihaela Visoiu
Director Acute Interventional Perioperative Pediatric Pain Service
University of Pittsburgh