Clinical trial NCT02472522: Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks
Official title: Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia in Patients Undergoing Cesarean Sections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Tata Main Hospital
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Time After the TAP Block When Rescue Analgesia Was First Sought
timeFrame: 24 hours
Secondary outcomes:
measure: Total Dose of Required Morphine in 24 Hours Postoperatively
timeFrame: 24 hours
measure: Adverse Effects Like Pruritus, Nausea and Vomiting
timeFrame: 24 hours
Other outcomes:
measure: Mean Arterial Pressure (MAP): Intraoperative Period
timeFrame: Upto 60 minutes
measure: Heart Rate: Intraoperative Period
timeFrame: 60 minutes
measure: Time to Complete Disappearance of Motor Block
timeFrame: 24 hours
measure: Duration of Sensory Loss at T10 Level
timeFrame: 24 hours
measure: Mean Arterial Pressure (MAP): Postoperative Period
timeFrame: 24 hours
measure: Heart Rate: Postoperative
timeFrame: 24 hours
measure: Visual Analogue Scale at Rest (VAS-R)
timeFrame: 24 hours
measure: Visual Analogue Scale on Coughing (VAS-C)
timeFrame: 24 hours
measure: Short Assessment of Patient Satisfaction Score (SAPS)
timeFrame: 24 hours
Locations:
city: Jamshedpur
country: India
facility: Tata Main Hospital
state: Jharkhand
Study officials:
affiliation: Tata Main Hospital, Jamshedpur, India
name: Priti Gehlot, DA
role: PRINCIPAL_INVESTIGATOR
References: