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

• Status: Terminated
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Pittsburgh; Mihaela Visoiu
• Treatments: Clonidine; Ropivacaine

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.