Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks

NCT02472522 | Completed Results DMC

• 1 other identifier: SR9851450
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Secondary Outcomes (2)

• Total Dose of Required Morphine in 24 Hours Postoperatively

  24 hours

• Adverse Effects Like Pruritus, Nausea and Vomiting

  24 hours

Other Outcomes (9)

• Mean Arterial Pressure (MAP): Intraoperative Period

  Upto 60 minutes

• Heart Rate: Intraoperative Period

  60 minutes

• Time to Complete Disappearance of Motor Block

  24 hours

Study Arms (2)

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)

Other: Ropivacaine

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

Drug: Ropivacaine + Dexmedetomidine

Interventions

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

Also known as: selective alpha 2 (α2) adrenergic agonist

Ropivacaine + Dexmedetomidine

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)

Ropivacaine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1 or 2
• Age above 18 years
• Patients for Lower Section Cesarean Section surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Main Hospital: lead

Study Sites (1)

Tata Main Hospital

Jamshedpur, Jharkhand, 831001, India

Location

MeSH Terms

Interventions

Ropivacaine; Dexmedetomidine; Adrenergic Agonists

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Limitations and Caveats

1. There was no mechanism in our study to ascertain the effectiveness or failure of the TAP block. 2. We did not ascertain if the effect of dexmedetomidine was by its systemic absorption or by a perineural effect.

Results Point of Contact

• Title: Specialist, Anaesthesia & Critical Care
• Organization: Tata Main Hospital, Jamshedpur, India

debsanjay@gmail.com

91-9431166582

Study Officials

• Priti Gehlot, DA

  Tata Main Hospital, Jamshedpur, India

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Specialist

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 16, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 6, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)