Pregnancy
Conditions
Brief summary
Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean Section.
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.
Interventions
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
OTHERRopivacaine
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)
Sponsors
Tata Main Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Time After the TAP Block When Rescue Analgesia Was First Sought | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Total Dose of Required Morphine in 24 Hours Postoperatively | 24 hours |
| Adverse Effects Like Pruritus, Nausea and Vomiting | 24 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of Sensory Loss at T10 Level | 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. |
| Mean Arterial Pressure (MAP): Postoperative Period | 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. |
| Heart Rate: Postoperative | 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. |
| Mean Arterial Pressure (MAP): Intraoperative Period | 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. |
| Visual Analogue Scale on Coughing (VAS-C) | 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 |
| Short Assessment of Patient Satisfaction Score (SAPS) | 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: 1. highly dissatisfied 2. dissatisfied 3. neither dissatisfied nor satisfied 4. satisfied 5. highly satisfied |
| Visual Analogue Scale at Rest (VAS-R) | 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 |
| Heart Rate: Intraoperative Period | 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 to Complete Disappearance of Motor Block | 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 1. = able to move knees, unable to raise extended legs 2. = able to flex ankles, unable to flex knees 3. = 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. |
Countries
India
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 50 |
| 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Ropivacaine | Ropivacaine + Dexmedetomidine |
|---|---|---|---|
| Age, Continuous | 28.34 Years STANDARD_DEVIATION 4.57 | 28.02 Years STANDARD_DEVIATION 4.64 | 28.66 Years STANDARD_DEVIATION 4.53 |
| Duration of surgery | 50.06 Minutes STANDARD_DEVIATION 4.14 | 50.12 Minutes STANDARD_DEVIATION 3.97 | 50.00 Minutes STANDARD_DEVIATION 4.35 |
| Height of the patients | 158.13 Centimeters STANDARD_DEVIATION 11.57 | 158.90 Centimeters STANDARD_DEVIATION 4.53 | 157.36 Centimeters STANDARD_DEVIATION 15.77 |
| Region of Enrollment India | 100 participants | 50 participants | 50 participants |
| Sex: Female, Male Female | 100 Participants | 50 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 64.88 Kilograms STANDARD_DEVIATION 6.78 | 64.08 Kilograms STANDARD_DEVIATION 5.96 | 65.68 Kilograms STANDARD_DEVIATION 7.49 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 50 | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
The Time After the TAP Block When Rescue Analgesia Was First Sought
Time frame: 24 hours
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine | The Time After the TAP Block When Rescue Analgesia Was First Sought | 13.12 Hours | Standard Deviation 3.53 |
| Ropivacaine + Dexmedetomidine | The Time After the TAP Block When Rescue Analgesia Was First Sought | 18.21 Hours | Standard Deviation 3.14 |
Secondary
Adverse Effects Like Pruritus, Nausea and Vomiting
Time frame: 24 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropivacaine | Adverse Effects Like Pruritus, Nausea and Vomiting | Nausea | 1 participants |
| Ropivacaine | Adverse Effects Like Pruritus, Nausea and Vomiting | Vomiting | 2 participants |
| Ropivacaine | Adverse Effects Like Pruritus, Nausea and Vomiting | No adverse effect | 47 participants |
| Ropivacaine + Dexmedetomidine | Adverse Effects Like Pruritus, Nausea and Vomiting | Nausea | 0 participants |
| Ropivacaine + Dexmedetomidine | Adverse Effects Like Pruritus, Nausea and Vomiting | Vomiting | 1 participants |
| Ropivacaine + Dexmedetomidine | Adverse Effects Like Pruritus, Nausea and Vomiting | No adverse effect | 49 participants |
Secondary
Total Dose of Required Morphine in 24 Hours Postoperatively
Time frame: 24 hours
Population: Only the mentioned number of patients needed analgesia within the first 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine | Total Dose of Required Morphine in 24 Hours Postoperatively | 8.16 Milligrams | Standard Deviation 2.94 |
| Ropivacaine + Dexmedetomidine | Total Dose of Required Morphine in 24 Hours Postoperatively | 6.21 Milligrams | Standard Deviation 0.8 |
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine | Duration of Sensory Loss at T10 Level | 303.74 minutes | Standard Deviation 7.86 |
| Ropivacaine + Dexmedetomidine | Duration of Sensory Loss at T10 Level | 305.40 minutes | Standard Deviation 7.19 |
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.
Time frame: 60 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine | Heart Rate: Intraoperative Period | At 50 minutes | 86.60 beats/minute | Standard Deviation 8.84 |
| Ropivacaine | Heart Rate: Intraoperative Period | At 60 minutes | 86.74 beats/minute | Standard Deviation 9.44 |
| Ropivacaine | Heart Rate: Intraoperative Period | Baseline | 85.64 beats/minute | Standard Deviation 7.75 |
| Ropivacaine | Heart Rate: Intraoperative Period | At 5 minutes | 94.52 beats/minute | Standard Deviation 10.68 |
| Ropivacaine | Heart Rate: Intraoperative Period | At 10 minutes | 96.60 beats/minute | Standard Deviation 11.92 |
| Ropivacaine | Heart Rate: Intraoperative Period | At 20 minutes | 93.84 beats/minute | Standard Deviation 10.35 |
| Ropivacaine | Heart Rate: Intraoperative Period | At 30 minutes | 91.08 beats/minute | Standard Deviation 8.71 |
| Ropivacaine | Heart Rate: Intraoperative Period | At 40 minutes | 87.96 beats/minute | Standard Deviation 8.46 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Intraoperative Period | At 40 minutes | 88.68 beats/minute | Standard Deviation 10.24 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Intraoperative Period | At 50 minutes | 87.52 beats/minute | Standard Deviation 10.17 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Intraoperative Period | At 10 minutes | 97.02 beats/minute | Standard Deviation 11.75 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Intraoperative Period | At 60 minutes | 88.50 beats/minute | Standard Deviation 11.28 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Intraoperative Period | At 30 minutes | 90.06 beats/minute | Standard Deviation 9.99 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Intraoperative Period | Baseline | 86.76 beats/minute | Standard Deviation 9.54 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Intraoperative Period | At 20 minutes | 93.28 beats/minute | Standard Deviation 10.46 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Intraoperative Period | At 5 minutes | 98.20 beats/minute | Standard Deviation 11.54 |
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.
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine | Heart Rate: Postoperative | At 12 hours | 85.26 beats/minute | Standard Deviation 13.48 |
| Ropivacaine | Heart Rate: Postoperative | At 18 hours | 80.88 beats/minute | Standard Deviation 10.44 |
| Ropivacaine | Heart Rate: Postoperative | On shifting | 84.92 beats/minute | Standard Deviation 13.9 |
| Ropivacaine | Heart Rate: Postoperative | At 1 hour | 86.74 beats/minute | Standard Deviation 9.56 |
| Ropivacaine | Heart Rate: Postoperative | At 4 hours | 83.50 beats/minute | Standard Deviation 8.07 |
| Ropivacaine | Heart Rate: Postoperative | At 8 hours | 81.46 beats/minute | Standard Deviation 9.11 |
| Ropivacaine | Heart Rate: Postoperative | At 24 hours | 78.82 beats/minute | Standard Deviation 6.59 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Postoperative | At 18 hours | 81.60 beats/minute | Standard Deviation 15.52 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Postoperative | At 12 hours | 83.18 beats/minute | Standard Deviation 8.03 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Postoperative | At 4 hours | 82.54 beats/minute | Standard Deviation 10.01 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Postoperative | At 24 hours | 79.14 beats/minute | Standard Deviation 6.64 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Postoperative | On shifting | 88.52 beats/minute | Standard Deviation 12.59 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Postoperative | At 8 hours | 81.14 beats/minute | Standard Deviation 10 |
| Ropivacaine + Dexmedetomidine | Heart Rate: Postoperative | At 1 hour | 86.50 beats/minute | Standard Deviation 12.09 |
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.
Time frame: Upto 60 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine | Mean Arterial Pressure (MAP): Intraoperative Period | Baseline | 76.84 millimeter of mercury (mmHg) | Standard Deviation 8.57 |
| Ropivacaine | Mean Arterial Pressure (MAP): Intraoperative Period | At 5 minutes | 68.28 millimeter of mercury (mmHg) | Standard Deviation 7.9 |
| Ropivacaine | Mean Arterial Pressure (MAP): Intraoperative Period | At 10 minutes | 67.42 millimeter of mercury (mmHg) | Standard Deviation 6.26 |
| Ropivacaine | Mean Arterial Pressure (MAP): Intraoperative Period | At 20 minutes | 70.02 millimeter of mercury (mmHg) | Standard Deviation 7.24 |
| Ropivacaine | Mean Arterial Pressure (MAP): Intraoperative Period | At 30 minutes | 72.46 millimeter of mercury (mmHg) | Standard Deviation 7.39 |
| Ropivacaine | Mean Arterial Pressure (MAP): Intraoperative Period | At 40 minutes | 75.82 millimeter of mercury (mmHg) | Standard Deviation 7.93 |
| Ropivacaine | Mean Arterial Pressure (MAP): Intraoperative Period | At 50 minutes | 76.98 millimeter of mercury (mmHg) | Standard Deviation 8.89 |
| Ropivacaine | Mean Arterial Pressure (MAP): Intraoperative Period | At 60 minutes | 79.66 millimeter of mercury (mmHg) | Standard Deviation 10.1 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Intraoperative Period | At 60 minutes | 84.02 millimeter of mercury (mmHg) | Standard Deviation 12.94 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Intraoperative Period | Baseline | 79.38 millimeter of mercury (mmHg) | Standard Deviation 10.4 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Intraoperative Period | At 30 minutes | 73.44 millimeter of mercury (mmHg) | Standard Deviation 8.68 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Intraoperative Period | At 5 minutes | 66.38 millimeter of mercury (mmHg) | Standard Deviation 7.97 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Intraoperative Period | At 50 minutes | 79.90 millimeter of mercury (mmHg) | Standard Deviation 10.67 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Intraoperative Period | At 10 minutes | 67.52 millimeter of mercury (mmHg) | Standard Deviation 8.62 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Intraoperative Period | At 40 minutes | 77.76 millimeter of mercury (mmHg) | Standard Deviation 9.55 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Intraoperative Period | At 20 minutes | 68.98 millimeter of mercury (mmHg) | Standard Deviation 8.63 |
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.
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine | Mean Arterial Pressure (MAP): Postoperative Period | 4 hours | 78.38 millimeter of mercury (mmHg) | Standard Deviation 9.72 |
| Ropivacaine | Mean Arterial Pressure (MAP): Postoperative Period | 12 hours | 82.90 millimeter of mercury (mmHg) | Standard Deviation 10.64 |
| Ropivacaine | Mean Arterial Pressure (MAP): Postoperative Period | 1 hour | 80.14 millimeter of mercury (mmHg) | Standard Deviation 10.58 |
| Ropivacaine | Mean Arterial Pressure (MAP): Postoperative Period | 18 hours | 83.94 millimeter of mercury (mmHg) | Standard Deviation 7.07 |
| Ropivacaine | Mean Arterial Pressure (MAP): Postoperative Period | 8 hours | 78.06 millimeter of mercury (mmHg) | Standard Deviation 8.34 |
| Ropivacaine | Mean Arterial Pressure (MAP): Postoperative Period | 24 hours | 77.24 millimeter of mercury (mmHg) | Standard Deviation 5.64 |
| Ropivacaine | Mean Arterial Pressure (MAP): Postoperative Period | On shifting | 79.98 millimeter of mercury (mmHg) | Standard Deviation 10.13 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Postoperative Period | 24 hours | 79.46 millimeter of mercury (mmHg) | Standard Deviation 7.76 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Postoperative Period | On shifting | 83.80 millimeter of mercury (mmHg) | Standard Deviation 13.33 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Postoperative Period | 1 hour | 83.46 millimeter of mercury (mmHg) | Standard Deviation 12.13 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Postoperative Period | 4 hours | 82 millimeter of mercury (mmHg) | Standard Deviation 11.6 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Postoperative Period | 8 hours | 81.26 millimeter of mercury (mmHg) | Standard Deviation 10.65 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Postoperative Period | 12 hours | 80.84 millimeter of mercury (mmHg) | Standard Deviation 9.8 |
| Ropivacaine + Dexmedetomidine | Mean Arterial Pressure (MAP): Postoperative Period | 18 hours | 85.08 millimeter of mercury (mmHg) | Standard Deviation 13.89 |
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).
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ropivacaine | Percentage of Patients Needing Rescue Analgesic | 50 percentage needing rescue analgesic |
| Ropivacaine + Dexmedetomidine | Percentage of Patients Needing Rescue Analgesic | 28 percentage needing rescue analgesic |
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: 1. highly dissatisfied 2. dissatisfied 3. neither dissatisfied nor satisfied 4. satisfied 5. highly satisfied
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine | Short Assessment of Patient Satisfaction Score (SAPS) | 4.22 Units on a scale | Standard Deviation 0.93 |
| Ropivacaine + Dexmedetomidine | Short Assessment of Patient Satisfaction Score (SAPS) | 4.70 Units on a scale | Standard Deviation 0.5 |
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 1. = able to move knees, unable to raise extended legs 2. = able to flex ankles, unable to flex knees 3. = 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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine | Time to Complete Disappearance of Motor Block | 171.06 minutes | Standard Deviation 5.51 |
| Ropivacaine + Dexmedetomidine | Time to Complete Disappearance of Motor Block | 170.34 minutes | Standard Deviation 14.62 |
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
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine | Visual Analogue Scale at Rest (VAS-R) | At 4 hours | 0.94 Units on a scale | Standard Deviation 0.65 |
| Ropivacaine | Visual Analogue Scale at Rest (VAS-R) | At 12 hours | 2.54 Units on a scale | Standard Deviation 1.49 |
| Ropivacaine | Visual Analogue Scale at Rest (VAS-R) | At 1 hour | 0.36 Units on a scale | Standard Deviation 0.56 |
| Ropivacaine | Visual Analogue Scale at Rest (VAS-R) | At 18 hours | 2.74 Units on a scale | Standard Deviation 1.44 |
| Ropivacaine | Visual Analogue Scale at Rest (VAS-R) | At 8 hours | 1.46 Units on a scale | Standard Deviation 0.86 |
| Ropivacaine | Visual Analogue Scale at Rest (VAS-R) | At 24 hours | 1.88 Units on a scale | Standard Deviation 0.38 |
| Ropivacaine | Visual Analogue Scale at Rest (VAS-R) | On shifting to postoperative area | 0.06 Units on a scale | Standard Deviation 0.31 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale at Rest (VAS-R) | At 24 hours | 1.78 Units on a scale | Standard Deviation 0.42 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale at Rest (VAS-R) | On shifting to postoperative area | 0.00 Units on a scale | Standard Deviation 0 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale at Rest (VAS-R) | At 1 hour | 0.38 Units on a scale | Standard Deviation 0.53 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale at Rest (VAS-R) | At 4 hours | 0.96 Units on a scale | Standard Deviation 0.53 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale at Rest (VAS-R) | At 8 hours | 1.34 Units on a scale | Standard Deviation 0.74 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale at Rest (VAS-R) | At 12 hours | 1.66 Units on a scale | Standard Deviation 0.52 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale at Rest (VAS-R) | At 18 hours | 2.12 Units on a scale | Standard Deviation 0.72 |
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
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine | Visual Analogue Scale on Coughing (VAS-C) | On shifting to postoperative area | 0.24 Units on a scale | Standard Deviation 0.52 |
| Ropivacaine | Visual Analogue Scale on Coughing (VAS-C) | At 1 hour | 1.12 Units on a scale | Standard Deviation 0.75 |
| Ropivacaine | Visual Analogue Scale on Coughing (VAS-C) | At 4 hours | 1.58 Units on a scale | Standard Deviation 0.7 |
| Ropivacaine | Visual Analogue Scale on Coughing (VAS-C) | At 8 hours | 2.22 Units on a scale | Standard Deviation 1.05 |
| Ropivacaine | Visual Analogue Scale on Coughing (VAS-C) | At 12 hours | 3.42 Units on a scale | Standard Deviation 1.76 |
| Ropivacaine | Visual Analogue Scale on Coughing (VAS-C) | At 18 hours | 3.52 Units on a scale | Standard Deviation 1.49 |
| Ropivacaine | Visual Analogue Scale on Coughing (VAS-C) | At 24 hours | 2.62 Units on a scale | Standard Deviation 0.6 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale on Coughing (VAS-C) | At 24 hours | 2.64 Units on a scale | Standard Deviation 0.52 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale on Coughing (VAS-C) | At 12 hours | 2.40 Units on a scale | Standard Deviation 0.64 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale on Coughing (VAS-C) | On shifting to postoperative area | 0.08 Units on a scale | Standard Deviation 0.27 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale on Coughing (VAS-C) | At 8 hours | 1.94 Units on a scale | Standard Deviation 0.65 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale on Coughing (VAS-C) | At 1 hour | 0.96 Units on a scale | Standard Deviation 0.57 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale on Coughing (VAS-C) | At 18 hours | 3.02 Units on a scale | Standard Deviation 0.82 |
| Ropivacaine + Dexmedetomidine | Visual Analogue Scale on Coughing (VAS-C) | At 4 hours | 1.48 Units on a scale | Standard Deviation 0.54 |