A comparison of quality of recovery after erector spinae block given with 20ml vs 30 ml of 0.375% Ropivacaine in patients undergoing modified radical mastectomy.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/07/055300
- Lead Sponsor
- Tata Main Hospital
- Brief Summary
Modified radical mastectomy is one of the most frequently practiced surgery . In MRM there is substantial dissection of nerve fibres. so, post op analgesia is difficult to provide. The incidence of post mastectomy pain syndromes is 20-60%. Quality of recovery after the surgery becomes an important parameter for a good postoperative outcome. One of the components of quality of recovery is good post operative pain management . Regional anaesthesia in the form of fascial blocks have taken the lead in this field. Erector Spinae Block - decreases acute post op pain, improve the quality of recovery in patients undergoing MRM surgeries.
**Research question:**Is the quality of recovery (QoR 40 Score)better when erector spinae plane block is given with 20ml of 0.375% Ropivacaine as compared to 30 ml of 0.375% Ropivacaine in patients undergoing modified radical mastectomy?
**Objectives:**Primary objective is to compare patient improvement with Quality of Recovery 40 (QoR 40) day after surgery. Secondary objective is 24 - hour postoperative pain scores (VAS) , post operative opioid consumption, time of first dose of rescue analgesic .
**Methodology:**Randomized Prospective Double blind study from 1.04.23 – 31.10.24 at Tata Main Hospital, Jamshedpur. Randomization will be done by computer generated random number. Blinding: the patient will be blind to the volume of drug used. Also, the person collecting the data and analyzing in the postoperative period will be different from the person doing the ESP Block. First GA will be administered with IV Fentanyl 2 mcg/kg, Propofol 2.5mg/kg, Vecuronium 0.1mg/kg at induction & ET intubation . After that patient is shifted to lateral position and a Single shot ESP block – US guided 13-6 Mhz (Sonosite M turbo), at T4 level using 100mm 20G USG needle (Stimuplex Ultra 360) is done . A volume of 0.375% Ropivacaine according to the group assigned is administered. Blocks will be performed by an anaesthesiologist who has previously done 25 or more ESPB before the commencement of study. Group A - patients will receive ultrasound guided ESPB with 20 ml of 0.375% Ropivacaine of along with general anaesthesia . Group B – patients will receive ultrasound guided ESPB with 30 ml of 0.375% Ropivacaine along with general anaesthesia. Patient is made Supine and 60 minutes after induction – Morphine 0.1 mg/kg IV is given. Maintenance in the form of O2/N2O, Vecuronium, Isoflurane is administered. Paracetamol 1gm IV half hour before end of surgery and 8 hourly postop and rescue analgesia in the form of Injection Tramadol 1.5 mg/kg when VAS≥4 is administered. Observations in the form of QoR - 40 Score (using QoR-40 Recovery Assessment Format), VAS score at 0,30,60,90(mins) 2 hours, 4,6,12,16,20,24 hours , time of first rescue analgesic, total requirement of opioid in first24 hours and vital parameters – HR, SBP, DBP, MAP, SpO2 ( Baseline, at induction, 5 minutes for first 10 mins and 10 mins till end of surgery will be recorded. Complications in the form of pnuemothorax, intramuscular Injection, bleeding will be recorded. Outcome variables will be: mean QoR 40 Score, mean 24hour VAS score, mean opioid consumption in first 24 hours post operatively, duration of block ( Time of administration of block to first dose of rescue analgesic).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 98
- ASA grade 1 to 3.
- Patients undergoing single side modified radical mastectomy for breast cancer.
- Patients refusing to participate in study.
- Bilateral breast surgery.
- Patients with allergy to local anesthetics.
- Patients with coagulopathy , infection at site of block and patients with neurological deficits.
- Patients on anti depressants or psychiatric drugs.
- Patients previously on pain medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean QoR (Quality of Recovery) 40 Score 24 HOURS
- Secondary Outcome Measures
Name Time Method Mean 24 hours VAS score. Mean opioid consumption in first 24 hours post operatively.
Trial Locations
- Locations (1)
Tata Main Hospital
🇮🇳Singhbhum, JHARKHAND, India
Tata Main Hospital🇮🇳Singhbhum, JHARKHAND, IndiaNirakar PahadiPrincipal investigator9040143917nirakarpahadi190@gmail.com