Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination
Status:
Terminated
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
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.