A study to compare the effects of a drug (dexmedetomidine) in chest wall nerve blocks (Pec 1 and Pec 2 blocks) for pain relief during and after surgery in breast cancer patients.

Not Applicable

Recruiting

• Conditions: 1.Female patients in the age group of 18 to 65 years.2.ASA Grade I or II3.Patients posted for elective modified radical mastectomy.

• Registration Number: CTRI/2018/05/014334
• Lead Sponsor: Dr Vijit Kumar

Brief Summary

The study would be done upon a total of 90 patients after approval of hospital ethics committee and obtaining written informed consent from all the patients.Patients would be randomly assigned to one of the three groups with a total of 30 patients in each group:-

**Group B** would receive Pec 1 and Pec 2 block with 30 ml 0.25% bupivacaine alone.

**Group Bd** would receive Pec 1 and Pec 2 block with 30 ml 0.25% bupivacaine with dexmedetomidine 0.5 microgram per kilogram body weight.

**Group BD** would receive Pec 1 and Pec 2 block with 30 ml 0.25% bupivacaine with dexmedetomidine 1.0 microgram per kilogram body weight.



On arrival in the operating room, baseline vitals of the patient would be recorded.General anaesthesia would be induced with injection of fentanyl 1 microgram per kg i.v. followed by propofol 1.5-2.0 mg/kg i.v. until loss of verbal response.Vecuronium 0.1 mg/kg i.v. would be used to facilitate tracheal intubation.Anaesthesia would be maintained with nitrous oxide 60% in oxygen and isoflurane 1.0%.



One of the investigators would prepare 30 ml of study drug with either of the aforementioned adjuvants according to the assigned group.The patient would receive ultrasound guided Pec 1 and Pec 2 blocks by an experienced anaesthesiologist who would be blinded to the contents of the drug given.



The **primary outcomes** would be assessed as follows:-

1.Quality of postoperative analgesia which would be assessed using VAS score.

2.Duration of analgesia (time to first rescue analgesia after administration of block).

3.Intraoperative hemodynamic parameters (mean blood pressure and heart rate).

4.Total analgesic consumption intraoperatively and in first 24 hours after surgery.



The **s****econdary outcomes** would be presence of any adverse effects like hypotension,nausea,vomiting,respiratory depression, and sedation score.



Data collected from 90 patients (30 in each study group) would be analysed to arrive at the results.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-30
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• 1.Patients of ASA Grade I or II.
• 2.Patients posted for elective modified radical mastectomy.

Exclusion Criteria

• 1.Patient is not giving informed consent.
• 2.Patients with BMI>35 kg/square metres.
• 3.Patients with sensitivity to local anaesthetics.
• 4.Patients with bleeding disorders or on anticoagulants.
• 5.Patients with spine or chest wall deformityor pregnancy.
• 6.Patients with local infection at the site of block.
• 7.Patients with significant neurological,cardiac,renal,hepatic or pulmonary disease.
• 8.Patients planned for breast conservative surgery or simple mastectomy with axillary clearance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Quality of postoperative analgesia which would be assessed using VAS score.	1.The VAS score would be assessed at 0,15,30,60 minutes over first 4 hours postoperatively and then at every 2 hours for first 12 hours and at every 4 hours for next 12 hours. | 2.Total analgesic consumption intraoperatively and in first 24 hours after surgery.
2.Duration of analgesia (time to first rescue analgesia after administration of block).	1.The VAS score would be assessed at 0,15,30,60 minutes over first 4 hours postoperatively and then at every 2 hours for first 12 hours and at every 4 hours for next 12 hours. | 2.Total analgesic consumption intraoperatively and in first 24 hours after surgery.
4.Total analgesic consumption intraoperatively and in first 24 hours after surgery.	1.The VAS score would be assessed at 0,15,30,60 minutes over first 4 hours postoperatively and then at every 2 hours for first 12 hours and at every 4 hours for next 12 hours. | 2.Total analgesic consumption intraoperatively and in first 24 hours after surgery.
3.Intraoperative hemodynamic parameters (mean blood pressure and heart rate).	1.The VAS score would be assessed at 0,15,30,60 minutes over first 4 hours postoperatively and then at every 2 hours for first 12 hours and at every 4 hours for next 12 hours. | 2.Total analgesic consumption intraoperatively and in first 24 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
1.Presence of any adverse effects like hypotension,nausea,vomiting,respiratory depression and sedation score.	The secondary outcomes are assessed immediately after surgery and for first 24 hours in postoperative period.

Trial Locations

Locations (1)

King George Medical University,Lucknow,UP-226003; 🇮🇳 Lucknow, UTTAR PRADESH, India

King George Medical University,Lucknow,UP-226003

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Vijit Kumar

Principal investigator

9936307388

vijitjaiswal3288@gmail.com