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Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean Section.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Placebo Comparator | 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) |
|
| Ropivacaine + Dexmedetomidine | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Time After the TAP Block When Rescue Analgesia Was First Sought | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Dose of Required Morphine in 24 Hours Postoperatively | 24 hours | |
| Adverse Effects Like Pruritus, Nausea and Vomiting | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure (MAP): Intraoperative Period | 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. | Upto 60 minutes |
| Heart Rate: Intraoperative Period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Priti Gehlot, DA | Tata Main Hospital, Jamshedpur, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Main Hospital | Jamshedpur | Jharkhand | 831001 | India |
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The study was conducted between May 2015 to November 2015 in the Obstetrics and Gynaecology Operation Theater and Post-operative ward of the Tata Main Hospital, Jamshedpur, India.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) 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) |
| FG001 | 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 Ropivacaine + Dexmedetomidine: 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 ) for the TAP block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with term pregnancy who were posted for Lower segment caesarean section were recruited for the study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 was 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) Ropivacaine: Patients satisfying inclusion criteria will received 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Time After the TAP Block When Rescue Analgesia Was First Sought | Number of patients who sought rescue analgesic within the first 24 hours postoperatively. Rest of the studied patients needed no rescue analgesic within the first 24 hours postoperatively. | Posted | Mean | Standard Deviation | Hours | 24 hours |
|
1st 24 hours postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Specialist, Anaesthesia & Critical Care | Tata Main Hospital, Jamshedpur, India | 91-9431166582 | debsanjay@gmail.com |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D020927 | Dexmedetomidine |
| D000322 | Adrenergic Agonists |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| 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) |
|
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. |
| 60 minutes |
| Time to Complete Disappearance of Motor Block | During the postoperative recovery, the level of motor block was assessed with Modified Bromage Scale 0 = no paralysis, able to flex hips/knees/ankles
| 24 hours |
| Duration of Sensory Loss at T10 Level | The duration of sensory loss (from the subarachnoid block) at T10 level was assessed by pin-prick test by a sterile needle in minutes. | 24 hours |
| Mean Arterial Pressure (MAP): Postoperative Period | 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. | 24 hours |
| Heart Rate: Postoperative | 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. | 24 hours |
| Visual Analogue Scale at Rest (VAS-R) | 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 | 24 hours |
| Visual Analogue Scale on Coughing (VAS-C) | 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 | 24 hours |
| Short Assessment of Patient Satisfaction Score (SAPS) | 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:
| 24 hours |
| BG001 | Ropivacaine + Dexmedetomidine | Patients satisfying the inclusion criteria received 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 was 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 Ropivacaine + Dexmedetomidine: 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 ) for the TAP block |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Height of the patients | Mean | Standard Deviation | Centimeters |
|
| Duration of surgery | Mean | Standard Deviation | Minutes |
|
| OG001 | 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 Ropivacaine + Dexmedetomidine: 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 ) for the TAP block |
|
|
| Secondary | Total Dose of Required Morphine in 24 Hours Postoperatively | Only the mentioned number of patients needed analgesia within the first 24 hours postoperatively | Posted | Mean | Standard Deviation | Milligrams | 24 hours |
|
|
|
| Secondary | Adverse Effects Like Pruritus, Nausea and Vomiting | Posted | Number | participants | 24 hours |
|
|
|
| Other Pre-specified | Mean Arterial Pressure (MAP): Intraoperative Period | 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. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Upto 60 minutes |
|
|
|
| Other Pre-specified | Heart Rate: Intraoperative Period | 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. | Posted | Mean | Standard Deviation | beats/minute | 60 minutes |
|
|
|
| Other Pre-specified | Time to Complete Disappearance of Motor Block | During the postoperative recovery, the level of motor block was assessed with Modified Bromage Scale 0 = no paralysis, able to flex hips/knees/ankles
| Posted | Mean | Standard Deviation | minutes | 24 hours |
|
|
|
| Other Pre-specified | Duration of Sensory Loss at T10 Level | The duration of sensory loss (from the subarachnoid block) at T10 level was assessed by pin-prick test by a sterile needle in minutes. | Posted | Mean | Standard Deviation | minutes | 24 hours |
|
|
|
| Other Pre-specified | Mean Arterial Pressure (MAP): Postoperative Period | 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. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | 24 hours |
|
|
|
| Other Pre-specified | Heart Rate: Postoperative | 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. | Posted | Mean | Standard Deviation | beats/minute | 24 hours |
|
|
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| Other Pre-specified | Visual Analogue Scale at Rest (VAS-R) | 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 | Posted | Mean | Standard Deviation | Units on a scale | 24 hours |
|
|
|
| Other Pre-specified | Visual Analogue Scale on Coughing (VAS-C) | 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 | Posted | Mean | Standard Deviation | Units on a scale | 24 hours |
|
|
|
| Other Pre-specified | Short Assessment of Patient Satisfaction Score (SAPS) | 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:
| Posted | Mean | Standard Deviation | Units on a scale | 24 hours |
|
|
|
| Post-Hoc | Percentage of Patients Needing Rescue Analgesic | Percentage of patients needing rescue analgesic. Rescue analgesia was provided with 6 mg of intravenous morphine and additional doses of 3 mg at 10 minutes interval till VAS was less than 3 or the 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). | Posted | Number | percentage needing rescue analgesic | 24 hours |
|
|
|
| 0 |
| 50 |
| 3 |
| 50 |
| EG001 | 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 Ropivacaine + Dexmedetomidine: 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 ) for the TAP block | 0 | 50 | 1 | 50 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D000588 |
| Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| No adverse effect |
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| 18 hours |
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| 24 hours |
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