Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

INCLUSION CRITERIA:

1. Adult patients aged between 18 and 65 years of either sex.

2. ASA I and ASA II undergoing general anesthesia for elective Robotic Spine surgery.

3. Mallampati class I and II.

EXCLUSION CRITERIA:

1. Patient refusal.

2. Body mass index ≥ 35 kg/ m2

3. Patients with cardiac, coronary, renal, hepatic, cerebral diseases and peripheral vascular diseases.

4. Patients coming for emergency surgeries.

5. Pregnancy.

6. Neuromuscular disorder.

7. Anticipated difficult intubation.

8. Inability to use VAS (Visual Analogue Scale).

9. History of allergy to Local Anaesthetics

 

BLINDING: It will be a double blinded study, both researcher and observer will be unaware of drug being administered.

 

Study subjects allocation –

Patients fulfilling the inclusion criteria will be divided randomly into two groups using the random table generator. On the day of surgery, the drug to be administered will be picked randomly from a sealed envelope by an anesthesiologist unrelated to study.

Group A- will receive IV lignocaine infusion 2 mg per kg per hour along with the standard TIVA regimen.

Group B- will receive IV placebo infusion (saline) along with the standard TIVA regimen.

c) Statistical methods :

Statistical analysis will be performed on SPSS software Version 20.0 (IBM Corp., Armonk, New York, USA). The distribution of variables will be evaluated for normality using the Kolmogorov-Smirnov and histogram tests. Descriptive data will be expressed as mean standard deviation. Categorical variables will be analyzed using the chi square test. Normally, distributed data comprising continuous variables will be analyzed using the Student t test. Otherwise, the Mann Whitney U test will be used. P < 0.05 will be considered statistically significant

Methodology:

After obtaining approval by the Institutional  scientific and ethics  Committee patients will be enrolled to the study. Written informed consent will be obtained from every patient. During the preoperative interview, in addition to the detailed pre anaesthetic check up and relevant work up, patient’s pain score will be assessed by the Visual Analogue Scale . Detailed Consent for the study will be taken.

The study will have two groups.

Group A : Will receive IV Lidocaine 2 mg/kg/hour infusion along with TIVA

Group B : Those will receive IV saline infusion along with TIVA.

On arrival to the operating room, standard ASA monitors will be applied (electrocardiography, non invasive blood pressure monitor, and pulse oximetry). A balanced intravenous crystalloid solution (lactated Ringer’s solution) will be  administered (2ml/kg/hr). Before induction, IV Ondansetron 4mg, IV Pantoprazole 40 mg will given. Anaesthetic induction will be performed while providing 100% oxygen (10 L/min). IV Lidocaine bolus of 1.5 mg/kg will be administered followed by which Infusion of study drug(based on the group randomisation) will be started . All patients will receive pre emptive analgesia with fentanyl (2mcg/kg), followed by hypnotic dose of IV Propofol (1.5–2 mg/kg) and Rocuronium (0.6-1.2mg/kg) for intubation. After endotracheal intubation,  patient will be positioned prone with optimal padding of pressure points .

Group A - Patients will receive the following TIVA regimen:1) propofol (50–150 μg/kg/hr), titrated to maintain entropy 40-60  2) lidocaine (2 mg/kg/hr) and 3) Fentanyl (0.5mcg/kg/hr)

Group B- Patients will receive the following TIVA regimen 1) propofol (50–150 μg/kg/hr titarted to maintain entropy 40-60 2)Placebo infusion containing physiological saline and 3) Fentanyl (0.5mcg/kg/hr) .

IV dexamethasone (4 or 8 mg) and IV Paracetamol 1g will be given intra operatively .

In both the groups Infusions will be stopped once skin suturing commences. Inhaled halogenated agents (sevoflurane) will be permitted, up to 0.5 minimum alveolar concentration (MAC), as needed and will also be tapered and stopped before extubation. Mechanical ventilation will be achieved with 1:1 mixture of oxygen:air (FiO2 50%) with a tidal volume of 6–8 ml/kg and respiratory rate of 12- 14 titrated to an end-tidal carbon dioxide between 30–35 mm Hg. Convective warming devices will be used to maintain normothermia . Need based fluid management will be carried out using dynamic indicators such as systolic pressure variability(SPV).  Invasive Hemodynamic monitoring will be done as per patient requirements. Entropy and Neuromuscular monitoring with Train of Four (TOF) and Post Tetanic Count( PTC) will be done throughout the surgery. In all patients, more than 20% elevation in mean arterial pressure and/or heart rate 15% above baseline (or higher) will be treated with additional bolus doses of Fentanyl(0.5 mcg/kg) and/or propofol (up to a 50-mg) boluses, and/ or by increasing the MAC of inhaled anaesthetics. These will be recorded. Post surgery, once patient is made supine, residual neuromuscular blockade will be reversed with IV Sugammadex 2mg/kg as per TOF count. Time to awakening after switching off propofol will be recorded in both the groups. Intraoperative incidence of hypotension and bradycardia will be recorded.

All procedures will be performed by a single surgeon and his team . All procedures will be provided anaesthesia by the same two anaesthesiologists .

In the PACU (Post Anaesthesia Care Unit) our analgesic regimen will be IV Ketorolac 0.5mg/kg in 100 ml NS and IV Paracetamol 1 g (15mg/kg) given 6^th hourly, IV Tramadol 50mg in 100 ml NS given 12^th hourly/ SOS and IV Pentazocine 10mg SOS(Upto 3 doses) . Rescue analgesic will be IV Fentanyl 0.5mcg/kg (given only in PACU for the first 4 hours) .

All patients will be assessed for pain scores( VAS)  at following time intervals- 30 minutes,  2 hr,4 hrs,8 hrs, 12 hrs and 16 hours, from the time of arrival to the PACU.

Their Hemodynamics will also be continuously monitored.

Incidence of PONV(Post Op Nausea and Vomiting) will be recorded in both groups.

Post operatively , NPO(Nil per oral) will be maintained  for 6 hours, following which patient will be restarted gradually on oral feeds with sips of water/juice.

Time to first mobilisation soon after surgery under guidance of a physical therapist will be recorded and patients will be discharged home early, as soon as the following conditions are true: 1) pain optimally controlled by oral analgesics, 2) no complication (e.g., incidental durotomy) that would require prolonged hospital stay, and 3) ability to climb stairs. Post discharge, patients will have a dedicated support line provided by the Spine care team; Surgical consultation will be routinely undertaken at 7th day Post operatively, during which Satisfaction Scores and Quality of Recovery will be recorded. The above two parameters will also be assessed at 1 month post operatively.

Outcome measures :

Primary outcome will be to assess –

●       Visual Analog Scale (VAS) ranging from 0 to 10 (0=no pain, 10=worst imaginable pain) to score the postoperative pain. The VAS scores will be recorded immediately in the recovery room at 30 minutes, 2 hr,4hr, 8hr, 12hr , and 24 hours postoperatively during bed rest and at 8, 12, and 24 hours during movement. Movement state defined as “moving from supine to semi sitting position”

Secondary outcomes will be :

●       Time to request of 1st rescue analgesic

●       Total Rescue analgesic used .

●       Total analgesics used in both groups

●       Total intraoperative Fentanyl use

●       Total Intraoperative Propofol use

●       Time to awakening( TA) after shutting anaesthetic agents in both groups

●       Richmond Agitation Sedation Score(RASS) at 1st, 2nd, 4th hour in PACU.

●       Hemodynamics recorded at the following time points: before induction, post intubation, before incision, at 1,2,4 hrs, at extubation,and at 1, 2 and 4 hrs post-operatively.

●       Time to feeding(Tf), Time to ambulation(Ta),

●       Adverse effects such as hypotension, Bradycardia(> 20% decline from baseline)/pruritus/ nausea and vomiting post operatively.

●       Length of Stay(LOS) in hospital(post surgery)

●       Incidence of Major/Minor complications will be recorded

●       Incidence of readmission will be recorded

●       Quality of recovery [15-item QoR questionnaire (QoR-15)¹⁵: scores ranging from 0 (poorest quality of recovery) to 150 (best quality of recovery)  will be assessed at 24 h, 7 days and 1month after surgery (APPENDIX)

●       Satisfaction scores of patients and surgeon 24 h , 7th day, 1 month following surgery (APPENDIX) using Five-point Likert scales (from 5 = very satisfied to 1 = very unsatisfied) will be used to assess patient satisfaction, including satisfaction with 1) overall participation of various specialities, 2) organization of preparation, 3)Pain control and 4) organization of discharge