DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks

Information source: Tata Main Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy

Intervention: Ropivacaine + Dexmedetomidine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Tata Main Hospital

Official(s) and/or principal investigator(s):
Priti Gehlot, DA, Principal Investigator, Affiliation: Tata Main Hospital, Jamshedpur, India

Overall contact:
Devi Prasad Samaddar, MD, Phone: 917763807300, Email: dp.samaddar@tatasteel.com

Summary

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

Clinical Details

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

Primary outcome: The time after the TAP block when rescue analgesia was first sought

Secondary outcome:

total dose of required morphine in 24 hours postoperatively

adverse effects like pruritus, nausea and vomiting

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

Locations and Contacts

Devi Prasad Samaddar, MD, Phone: 917763807300, Email: dp.samaddar@tatasteel.com

Tata Main Hospital, Jamshedpur, Jharkhand 831001, India; Recruiting
Mamta Rath Datta, MS, Phone: 917763807402, Email: drmamtadatta@gmail.com
Abhishek Chatterjee, DNB, Phone: 7763807075, Email: dr.abhishekchatterjee@gmail.com
Additional Information

Starting date: May 2015
Last updated: June 15, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017