Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks
Condition: Pregnancy
Study type: Interventional

Summary: 
      Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus
      abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean
      Section.
    

Detailed description: 
      Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy
      0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. Routine NPO protocols will be followed.
      At the end of the procedure, bilateral TAP block will be performed using Landmark Technique
      in Triangle of Petit with 2 inches 24 G needle.

      Patients would receive 75 mg of intramuscular diclofenac sodium immediately on shifting to
      the postoperative care unit (PACU) and a second dose 12 hours later. The time after the TAP
      block when rescue analgesia was first sought, total dose of required morphine in 24 hours
      postoperatively, its adverse effects like pruritus, nausea and vomiting will be recorded. VAS
      will be used to assess post-operative pain (VAS; where 0 = no pain and 10 = worst imaginable
      pain) during rest and on coughing.

      Rescue analgesia would be provided with 6 mg of intravenous morphine and additional doses of
      3 mg at 10 minutes interval till VAS was less than 3 or in case of development of adverse
      effects such as nausea and/or vomiting, respiratory depression (SpO2 <92%, ventilatory
      frequency rate <10), or occurrence of deep sedation (eyes closed >3 min, Ramsay Score RS >2).
      An RS on a 6-point scale was used (1=anxious and agitated patient; 2=cooperative patient;
      3=asleep patient, brisk response to loud voice; 4=asleep patient, sluggish response to loud
      voice; 5=no response to loud voice; score of 6=no response to pain). In PACU and in first 24
      h post-operatively, MAP, HR, VAS (at rest and on coughing), nausea and vomiting, sedation
      score (RS) will be recorded on admission to PACU and at 1,4, 8, 12, 18 and 24 hours
      post-operatively by an observer who will be unaware of the study protocol.

      Patients will we assessed on a 5 point scale at the end of 24 hours on the quality of
      postoperative analgesia. Nausea and vomiting will be recorded using a categorical scoring
      system (0 = none, 1 = nausea, 2 = retching, 3 = vomiting). IV Metoclopramide 10 mg bolus will
      be offered for any patient with a score >/=1.
    

Intervention name(s): Ropivacaine + Dexmedetomidine; Ropivacaine
Intervention type(s): Drug; Other
Intervention description(s): Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine and 1 micrograms/kg dexmedetomidine (combination drug) diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block; Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Other intervention name(s): selective alpha 2 (α2) adrenergic agonist
Intervention MeSH terms: Dexmedetomidine; Ropivacaine; Adrenergic Agonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment