Tata Main Hospital
Jamshedpur, Jharkhand, 831001, India
NCT Number: NCT02472522
Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean Section.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Jamshedpur, Jharkhand, 831001, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: selective alpha 2 (α2) adrenergic agonist
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)
Time frame: 24 hours
Time frame: 24 hours
Time frame: 24 hours
Time frame: Upto 60 minutes
The Mean Arterial Pressure (MAP) of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.
Time frame: 60 minutes
The Heart Rate of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.
Time frame: 24 hours
During the postoperative recovery, the level of motor block was assessed with Modified Bromage Scale 0 = no paralysis, able to flex hips/knees/ankles
Time frame: 24 hours
The duration of sensory loss (from the subarachnoid block) at T10 level was assessed by pin-prick test by a sterile needle in minutes.
Time frame: 24 hours
The Mean Arterial Pressure (MAP) of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.
Time frame: 24 hours
The Heart Rate of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.
Time frame: 24 hours
Visual Analogue Scale at rest (VAS-R) was used to assess Post-operative Pain at rest. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour
Time frame: 24 hours
Visual Analogue Scale on Coughing (VAS-C) Was Used to Assess Post-operative Pain on Coughing. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour
Time frame: 24 hours
Short assessment of patient satisfaction score(SAPS) was assessed on a 5 point scale at the end of 24 hours on the quality of postoperative analgesia. where:
Tata Main Hospital
Other
Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia in Patients Undergoing Cesarean Sections
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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