Efficacy of peripheral nerve block as post operative analgesia in modified radical mastectomy
- Conditions
- Malignant neoplasm of breast,
- Registration Number
- CTRI/2019/11/022086
- Lead Sponsor
- SSG Hospital Vadodara
- Brief Summary
The study will be a type of prospective randomized controlled study undertaken in adults patients undergoing MRM admitted in SSG Hospital with a sample size of 60 patients,
Patient to be kept nil by mouth (NBM) for minimum 6-8 hours and an intravenous line will be secured. After thorough pre-anaesthetic evaluation all the patients falling in the inclusion criteria will be selected and informed written consent will be taken from the patient
After taking patient inside the operation theatre, multipara monitor will be attached and baseline vital parameter like pulse rate, bood pressure, SpO2, ECG will be noted. As premedication, Inj. Glycoprrolate 5mcg/kg iv and Inj. Tramadol 2mg/kg iv 5 minutes prior to induction.
**Induction** will be the same in both groups A and B, starting preoxygenation with 100% O2 for 3min will be done by using close circuit of Fabius anaesthesia machine.Inj. Propofol 2 mg/kg IV will be given till loss of eye lash reflex. Inj. Suxamethonium Chloride 2 mg/kg IV given after check ventilation.Intubation will be done in sniffing position by direct laryngoscopy with no 3 mac blade with appropriate size endotracheal tube after disappearance of fasciculation and confirmed by Capnometry. Patient will be then ventilated with Oâ‚‚ & Nâ‚‚O (50:50%) gases along with inhalational agent Sevoflurane turned on. Inj.Vecuronium bromide 0.1 mg/kg will be given as loading dose. (Muscle relaxants will be given intravenously after performing blocks in case of group B patients).
Block will be performed in group B patients using peripheral nerve stimulator and drug will be prepared as Injection Bupivacaine 0.5% 15 cc; Injection sterile water 15cc; Total drug 30cc of 0.25% Bupivacaine.
**PEC I BLOCK**
• The PEC-I block will be performed with the guidance of PNS with the patient lying in supine position with ipsilateral arm slightly abducted. The landmark will be the point of intersection of angle of Louis (2nd Rib) and the anterior axillary line where the needle will be inserted. The block will be done with a 50 mm insulated nerve stimulator needle with syringe filled with local anaesthetic (LA) attached to the extension tubing and the needle will be inserted perpendicular to the skin, at the landmark described above. The PNS will be initially set at 2.5 - 3 mA current, 0.1ms duration and frequency of 1Hz. The needle then slowly advanced till the pectoralis muscle contractions noted. The needle will be kept at this depth and current will be gradually reduced to 0.6mA. Persistence of contraction of pectoralis muscle at this level confirms the needle placement at the target site thereby blocking lateral pectoral nerve and medial pectoral nerve. Injection Bupivacaine 0.25% of 10cc will be then slowly injected in increments with frequent negative aspirations.
• **SAP BLOCK**
The SAP block will be performed with the guidance of PNS with the patient lying in supine position and ipsilateral arm abducted. The landmark will be the point of intersection of 5th Rib and the mid axillary line where the needle is inserted. The block will be done with a 50 mm insulated nerve stimulator needle with syringe filled with local anaesthetic (LA) attached to the extension tubing and the needle will be inserted perpendicular to the skin, at the landmark described above. The PNS will be initially set at 2.5 - 3 mA current, 0.1ms duration, and frequency of 1Hz. The needle will be slowly advanced till the serratus anterior muscle contractions noted. The needle will be kept at this depth and current will be gradually reduced to 0.6 mA. Persistence of contraction of serratus anterior muscle at this level confirms the needle placement at the target site thereby blocking lateral and posterior cutaneous branches of intercostal nerves and long thoracic nerve . Injection Bupivacaine 0.25% of 20cc will be then slowly injected in increments with frequent negative aspirations.
Cylinders and circuits will be checked, airway equipment and drugs will be kept ready before induction.
All the blocks will be given by me after a learning curve of 10 such cases.
**Maintainence**:
Patient will be then maintained with O₂+N₂O (50:50) with sevoflurane and vecuronium bromide 0.02 mg/kg. Intraoperative rise in heart rate and systolic blood pressure ≥ 20% from pre induction value will be managed by giving intravenous Inj. fentanyl 0.25microgram/kg. Fluid requirement and blood loss will be calculated and replaced accordingly. Towards the end of surgery, all patients (in group A and B) will be given inj. Paracetamol 1g/100ml intravenously.
**Reversal**:
At the end of surgery N2O and anaesthetic agent will be stopped before 10 mins and patient will be ventilated with 100% oxygen. Reversal of residual neuromuscular block will be done, once patient starts spontaneous breathing, with Inj. Neostigmine - 50 mcg/kg iv and Inj. Glycopyrrolate - 10 mcg/kg iv.
During this period patient will be ventilated with 100% oxygen with fresh gas flow of 4- 6 litres/min. Patient will be extubated when regular spontaneous breathing pattern become established and able to open the eyes on command. Patient will then be shifted to recovery room after monitoring for 15minutes inside operation theatre.
1. POSTOPERATIVE MONITORING:
(i) VAS Score: Score recorded by making handwritten mark on a 10cm line that represents a continuum between “no pain†and “worst painâ€. Postoperatively patient will be enquired regarding intensity of pain at rest, with mild pressure over surgical site and with movements over shoulder joint. VAS score will be assessed every 1hour for first 6 hours, every 2 hours for next 6 hours and at 18 and 24 hours.
(ii) TIME OF 1ST RESCUE ANALGESIA GIVEN: Rescue analgesia will be given in the form of inj. Tramadol 2 mg/kg intravenously when VAS score will be ≥ 4 and time at which 1st rescue analgesic required will be noted. Time from when the blocks given till the supplementation of 1st rescue analgesic will be considered as duration of postoperative analgesia.
(iii) TOTAL REQUIREMENT OF RESCUE ANALGESIA IN 1ST 24 HOURS:
Total number of doses of rescue analgesics given in 1st 24 hours will be noted.
(iv) PERI OPERATIVE COMPLICATIONS
• Pneumothorax – if suspected immediate CXR will be done and ICD insertion if necessary.
• Local anaesthetics toxicity – will be treated symptomatically.
• Postoperative nausea and vomiting – will be treated by Inj. Ondansetron 0.15 mg/kg iv.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 60
1)All patients having Unilateral Breast Carcinoma 2)ASA – II/III 3)Scheduled for Modified Radical Mastectomy.
- 1)Patient’s refusal 2)Patients with allergy to study medication such as Bupivacaine and Tramadol.
- 3)Locally advanced breast malignancies with skin ulceration or infiltration of chest wall 4)Long-term analgesic therapy 5)Bleeding dyscrasias 6)Patient on anticoagulants 7)History of neurological or neuromuscular disorders 8)Deranged liver function tests.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) Score (post operatively). 24 hours
- Secondary Outcome Measures
Name Time Method 1) Time to give 1st rescue analgesia 2) Total dose requirement of rescue analgesics in 1st 24 hours.
Trial Locations
- Locations (1)
SSG Hospital
🇮🇳Vadodara, GUJARAT, India
SSG Hospital🇮🇳Vadodara, GUJARAT, IndiaDr VM Ananda JyothiPrincipal investigator9840217023annejyo@yahoo.co.in