Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks

Overview

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

Full Title of Study: “Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia in Patients Undergoing Cesarean Sections”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: November 2015

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.

Interventions

  • Drug: Ropivacaine + Dexmedetomidine
    • 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
  • Other: Ropivacaine
    • 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)

Arms, Groups and Cohorts

  • Placebo Comparator: Ropivacaine
    • 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)
  • Experimental: Ropivacaine + Dexmedetomidine
    • 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 addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block

Clinical Trial Outcome Measures

Primary Measures

  • The Time After the TAP Block When Rescue Analgesia Was First Sought
    • Time Frame: 24 hours

Secondary Measures

  • Total Dose of Required Morphine in 24 Hours Postoperatively
    • Time Frame: 24 hours
  • Adverse Effects Like Pruritus, Nausea and Vomiting
    • Time Frame: 24 hours

Participating in This Clinical Trial

Inclusion Criteria

  • ASA 1 or 2 – Age above 18 years – Patients for Lower Section Cesarean Section surgery Exclusion Criteria:

  • Patient refusal – Allergy to study medications – Localized infection over injection point – Patients with significant coagulopathies and with contraindications to regional anesthesia – Patients with a history of cardiac, respiratory, renal or hepatic failure – Psychological disorders – Chronic use of pain medications or adrenoreceptors agonists or antagonists. – BMI >35 or weight < 50 kilograms

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tata Main Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr.Deb Sanjay Nag, Associate Specialist – Tata Main Hospital
  • Overall Official(s)
    • Priti Gehlot, DA, Principal Investigator, Tata Main Hospital, Jamshedpur, India

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