The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
Condition: Hernia, Inguinal; Hydrocele
MeSH terms: Testicular Hydrocele; Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 2

Summary: 
      The current study will compare the effects on postoperative pain relief of "freezing"
      (ropivacaine 0.2 %) alone and in combination with clonidine for a nerve block in children
      undergoing hernia repair. The researchers anticipate that the addition of clonidine to
      "freezing" will result in prolongation of postoperative pain relief in children undergoing
      hernia repair compared to "freezing" used alone.
    

Detailed description: 
      The optimal method of controlling postoperative pain in children undergoing hernia repair
      would effectively relieve pain for extended periods of time and have no adverse effects.
      Unfortunately, such an ideal technique does not exist.

      The control of postoperative pediatric pain after hernia repair is achieved with a
      combination of oral and intravenous pain medications and "nerve blocks". "Nerve blocks" are
      achieved by injecting local anesthetics or what is commonly referred to as "freezing "next to
      the nerve supply of the wound. "Freezing" the major nerves supplying sensation at the site of
      hernia repair in children, while they are asleep, is effective. At CHEO, this technique in
      addition to administering ketorolac, a liquid intravenous form of an anti-inflammatory agent
      similar to Advil, is the current technique of choice for postoperative pain control after
      inguinal hernia.

      It is not unusual for these patients to require extra pain medications postoperatively.
      Available means of pain control in addition to those mentioned above include codeine-like
      medications, Tylenol, Advil-like medications and opioids administered intravenously. The
      addition of these medications increases the risk of suffering from side effects including
      respiratory depression, nausea and vomiting, and itching.

      Ideally, the prolongation of postoperative pain relief by the addition of a second medication
      to the "freezing" during the nerve block would limit the need for additional pain medication
      and hence, decrease their associated side effects. Clonidine has the potential to be such a
      medication. It has been shown to provide pain relief by affecting several areas of the
      nervous system including the brain, the spinal cord and nerves. Clonidine prolongs pain
      relief of certain local anesthetics when used in nerve blocks for adults. Unfortunately,
      there are no studies that have examined the combination of clonidine and the local anesthetic
      ropivacaine for nerve blocks in children. Presently, the injectable form of clonidine is not
      marketed and is considered investigational in Canada.

      The current study will be a prospective double -blind, randomized, controlled trial. It will
      compare the effects on postoperative pain relief of "freezing" (ropivacaine 0.2 %) alone and
      in combination with clonidine for a nerve block in children undergoing hernia repair. In
      addition, it will measure changes in the child's level of sedation, breathing, heart rate,
      blood pressure and any complications. Finally, it will assess how satisfied the parents are
      with this technique.

      The researchers anticipate that the addition of clonidine to "freezing" will result in
      prolongation of postoperative pain relief in children undergoing hernia repair compared to
      "freezing" used alone.
    

Intervention name(s): clonidine
Intervention type(s): Drug
Intervention description(s): 2 mcg clonidine added to local anesthetic
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: unilateral; hernia; hydrocele; pediatric; clonidine; nerve block