Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks
Information source: Tata Main Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy
Intervention: Ropivacaine + Dexmedetomidine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Tata Main Hospital Official(s) and/or principal investigator(s): Priti Gehlot, DA, Principal Investigator, Affiliation: Tata Main Hospital, Jamshedpur, India
Overall contact: Devi Prasad Samaddar, MD, Phone: 917763807300, Email: dp.samaddar@tatasteel.com
Summary
Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus
abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean
Section.
Clinical Details
Official title: Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia in Patients Undergoing Cesarean Sections
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The time after the TAP block when rescue analgesia was first sought
Secondary outcome: total dose of required morphine in 24 hours postoperativelyadverse effects like pruritus, nausea and vomiting
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Devi Prasad Samaddar, MD, Phone: 917763807300, Email: dp.samaddar@tatasteel.com
Tata Main Hospital, Jamshedpur, Jharkhand 831001, India; Recruiting Mamta Rath Datta, MS, Phone: 917763807402, Email: drmamtadatta@gmail.com Abhishek Chatterjee, DNB, Phone: 7763807075, Email: dr.abhishekchatterjee@gmail.com
Additional Information
Starting date: May 2015
Last updated: June 15, 2015
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