Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472522
• Other study ID #: SR9851450
• Status: Completed
• Phase: N/A
• First received: June 9, 2015
• Last updated: December 21, 2015
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Tata Main Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean Section.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• 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

Other:
• 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)

Locations

Country	Name	City	State
India	Tata Main Hospital	Jamshedpur	Jharkhand

Sponsors (1)

Lead Sponsor	Collaborator
Tata Main Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time after the TAP block when rescue analgesia was first sought		24 hours	No
Secondary	total dose of required morphine in 24 hours postoperatively		24 hours	No
Secondary	adverse effects like pruritus, nausea and vomiting		24 hours	No