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Completed

NCT Number: NCT02472522

Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks

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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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tata Main Hospital

Jamshedpur, Jharkhand, 831001, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine + Dexmedetomidine

Drug

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

ropivacaine

Other

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)

Primary outcomes

  1. The Time After the TAP Block When Rescue Analgesia Was First Sought

    Time frame: 24 hours

Secondary outcomes

  1. Total Dose of Required Morphine in 24 Hours Postoperatively

    Time frame: 24 hours

  2. Adverse Effects Like Pruritus, Nausea and Vomiting

    Time frame: 24 hours

Other outcomes

  1. Mean Arterial Pressure (MAP): Intraoperative Period

    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.

  2. Heart Rate: Intraoperative Period

    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.

  3. Time to Complete Disappearance of Motor Block

    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

    • = able to move knees, unable to raise extended legs
    • = able to flex ankles, unable to flex knees
    • = unable to move any part of the lower limb The time from subarachnoid block to complete disappearance of motor block (Bromage 0) was recorded in minutes.
  4. Duration of Sensory Loss at T10 Level

    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.

  5. Mean Arterial Pressure (MAP): Postoperative Period

    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.

  6. Heart Rate: Postoperative

    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.

  7. Visual Analogue Scale at Rest (VAS-R)

    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

  8. Visual Analogue Scale on Coughing (VAS-C)

    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

  9. Short Assessment of Patient Satisfaction Score (SAPS)

    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:

    • highly dissatisfied
    • dissatisfied
    • neither dissatisfied nor satisfied
    • satisfied
    • highly satisfied

Sponsors and collaborators

Lead sponsor

Tata Main Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 16, 2015
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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