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Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks

2015-06-17 03:38:24 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Pregnancy

Intervention

Ropivacaine + Dexmedetomidine

Location

Tata Main Hospital
Jamshedpur
Jharkhand
India
831001

Status

Recruiting

Source

Tata Main Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-17T03:38:24-0400

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Medical and Biotech [MESH] Definitions

Proteins produced by organs of the mother or the PLACENTA during PREGNANCY. These proteins may be pregnancy-specific (present only during pregnancy) or pregnancy-associated (present during pregnancy or under other conditions such as hormone therapy or certain malignancies.)

The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.

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MULTIPLE PREGNANCY with EMBRYO IMPLANTATION occuring at different locations, involving both an intrauterine site and an extrauterine (ECTOPIC PREGNANCY) site.

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