Caudal Ropivacaine With or Without Dexmedetomidine for Post Operative Analgesia
Condition: Ropivacaine; Infraumbilical Surgery; Dexmedetomidine; Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the postoperative analgesic effects of caudal
      Ropivacaine with or without Dexmedetomidine in pediatric infraumbilical surgery. The main
      question[s] it aims to answer are:

      • if Caudal Dexmedetomidine with Ropivacaine would prolong the duration of analgesia in
      children undergoing infraumbilical surgery.

      Participants will receive ropivacaine with dexmedetomidine in infraumbilical surgery.

      If there is a comparison group: Investigators will compare this with ropivacaine with a
      placebo to see if the duration of analgesia differs.
    

Detailed description: 
      Children have significant pain following surgery. It has been under-managed most of the time.
      Poorly controlled post-operative pain increases the morbidity. It leads to post-operative
      agitation, urinary retention, nausea and vomiting, hypoxia, pulmonary edema, cardiovascular
      and temperature instability. So, postoperative pain management is an essential and important
      component of pediatric postoperative care. Adequate pain control after surgery permits early
      mobilization, reduces postoperative complication, prevents development of fear and anxiety
      and allows early hospital discharge.

      Caudal block is one of the modality of multimodal analgesia. It is a well-established,
      effective and relatively safe technique used for intra and post-operative analgesia in
      children undergoing abdominal and lower limb surgery. It provides excellent analgesia,
      reduces intra-operative anesthetics drug requirements, ensures pain free recovery from
      anesthesia, decreases stress response and avoids deleterious adverse effects of narcotic
      drugs.

      However, the main disadvantage of caudal block is being its short duration of action with
      sole local anesthetics. Even long-acting local anesthetic drugs such as bupivacaine provides
      only 4-8 hours of analgesia. The insertion of catheter in caudal space to administer repeated
      doses or continuous infusions of local anesthetic drug is not popular because of concerns of
      infection. So, various adjuvants like Fentanyl, Morphine, Ketamine, clonidine,
      Dexmeditomidine etc. have been used to prolong the duration of analgesia.

      Morphine and Fentanyl are opioids that have been used traditionally in combination with a
      local anesthetic to achieve prolonged anesthetic effect. The addition of opioid does provide
      better analgesia but there is a possibility of an increased incidence of pruritus, urinary
      retention, nausea, vomiting and respiratory depression. Similarly, Ketamine and Clonidine are
      the widely preferred adjuvant to caudal block but have their own number of unpleasant adverse
      effects8.

      Hence, there is still ongoing investigations to find for an adjuvant that can safely prolong
      caudal analgesia. Recently, Dexmedetomidine has been used for this purpose. Various studies
      have described the use of Dexmedetomidine with local anesthetic drugs in caudal block for the
      management of postoperative pain in children. Saadawy et al. found that 1μg/kg caudal
      dexmedetomidine with bupivacaine was associated with an extended duration of postoperative
      analgesia while in other studies 2μg/kg Dexmedetomidine was used with caudal Bupivacaine or
      Ropivacaine for providing postoperative analgesia in children undergoing lower abdominal and
      perineal surgeries.

      Dexmedetomidine is a highly specific and selective α2-adrenoceptor agonist that has been
      described as a safe and effective additive in many anesthetic procedures. In contrast to
      other agents, it has a sympatholytic, analgesic and sedative effects. It is remarkably free
      from side effects except for hypotension and bradycardia. But studies investigating its
      analgesic property in our population are limited.

      Ropivacaine is a long-acting amino amide local anesthetic drug and was the first to be
      formulated as a pure S-enantiomer. It is reported to have a better safety profile than
      Bupivacaine with less risk for central nervous system and cardiac toxicity 10. It also
      decreases unwanted motor block than Bupivacaine, which makes it a more suitable agent for
      caudal epidural analgesia6.

      Dexmedetomidine with Ropivacaine is commonly used to prolong the caudal analgesia in western
      population but have not been well studied in our pediatric population. So investigators
      designed this study to determine analgesic effect of caudal Dexmedetomidine with Ropivacaine
      in pediatric infraumbilical surgeries.

      HYPOTHESIS Caudal Dexmedetomidine with Ropivacaine would not prolong the duration of
      analgesia in children undergoing infraumbilical surgery.

      GENERAL OBJECTIVES To evaluate the postoperative analgesic effects of caudal Ropivacaine with
      or without Dexmedetomidine in pediatric infraumbilical surgery SPECIFIC OBJECTIVES

        1. To compare rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)in 24
           hours of postoperative period.

        2. To compare the time for first rescue analgesia.

        3. To evaluate the total analgesics consumption in 24 hours of postoperative period.

        4. To observe the side effects of study drugs (vomiting and bradycardia).
    

Intervention name(s): ropivacaine with dexmedetomidine; Ropivacaine with placebo
Intervention type(s): Drug; Drug
Intervention description(s): this group received with ropivacaine with dexmedetomidine; this group received with ropivacaine with normal saline
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children were randomly assigned to two groups having 31 children in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: ropivacaine; caudal ropivacaine; dexmedetomidine; placebo; analgesia; infraumbilical surgery