Comparing two techniques of ultrasound guided nerve block for postoperative pain relief in patients for breast surgery.

Phase 4

Not yet recruiting

• Conditions: Patients having carcinoma breast undergoing modified radical mastectomy

• Registration Number: CTRI/2018/05/013660
• Lead Sponsor: Sir Ganga Ram Hospital

Brief Summary

Breast cancer is most commonly diagnosed malignancy. Acute postoperative pain is a risk factor in development of chronic post mastectomy pain and seen in 40%patients after surgery. It has profound effect on health related quality of life, anxiety, depression, postoperative nausea and vomiting.They also show lower rates of satisfaction, increased hospital costs.

Regional anaesthesia techniques provide better control of acute pain leading to less postoperative chronic pain. Mechanism is decreased central sensitisation and improve patient outcome in terms of acute and persistent post surgical pain (PPSP).

The advancement of ultrasound technology has increased interest in performing thoracic paravertebral and pectoral block

Our study prospectively compares ultrasound guided thoracic paravertebral block versus ultrasound guided paravertebral and pectoral I block in patients undergoing modified radical mastectomy surgery for duration of analgesia, postoperative pain,perioperative analgesic consumption, postoperative nausea and vomiting and PPSP.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-01-05
• Study Start: 2018-10-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• Gender: female patients undergoing elective unilateral MRM surgery.
• ASA physical status I, II and III 3.
• Age more than 18 years.

Exclusion Criteria

• Patient’s refusal 2.
• Declining to give written informed consent, 3.
• History of allergy to the medications used in the study, 4.
• Contraindications to regional anesthesia (including coagulopathy and local infection), •Prior breast surgery except for diagnostic biopsies, • History of treatment for a chronic pain condition and/or psychiatric disorder.
• •ASA grade physical status III/IV •Metabolic disorders (liver and kidney disease).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in duration of analgesia between three groups	Difference in duration of analgesia between three groups

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	At 0, 30, 60,90, 120 minutes postoperatively
Intraoperative analgesic consumption	Throughout intraoperative period
Postoperative nausea and vomiting (PONV)	At 0, 30, 60, 90, 120 minutes postoperatively
Acute postoperative pain relief as assessed by visual analogue scale (VAS)	At o, 30, 60, 90,120 minutes postoperatively
Assess difference in postoperative pain scores at 3 and 6 months	At 3 and 6 months

Trial Locations

Locations (1)

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

Sir Ganga Ram Hospital

🇮🇳Delhi, DELHI, India

Dr Anirban Roy

Principal investigator

9910181136

dr.anirvan@gmail.com