Comparison between two drugs as an alternative to drugs causing nausea ,vomiting ,sedation and respiratory depression in spine surgeries.

Not yet recruiting

• Conditions: Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,

• Registration Number: CTRI/2023/06/053997
• Lead Sponsor: St Johns Medical College and Hospital

Brief Summary

This is a randomized control study and aims to compare efficacy of two drugs lignocaine and dexmedetomidine with erector spinae block as opioid free anesthetic technique in lumbar spine surgeries. Primary objective of the study is to assess duration of analgesia between the two groups (lignocaine vs dexmedetomidine) in the postoperative period .The secondary objectives are to assess the hemodynamic parameters such as heart rate ,systolic blood pressure (SBP),diastolic blood pressure (DBP),mean arterial pressure and saturation ,to assess the total rescue analgesic (ketamine)consumed between two groups ,to assess total analgesic consumption of two groups, to assess severity of pain postoperatively using NRS score at rest and movement between two groups and to assess total dose of rescue analgesia used post operatively between two groups. The recruited patients will be randomized and allocated into two groups-Group L (control) and Group D (intervention )with 25 patients in each  by computer generated table .Group L will receive 1.5mg/kg  lignocaine bolus over 15 min followed by 1mg/kg/hr and Group D will receive 1 mcg/kg dexmedetomidine over 15 min followed by 0.5 mcg/kg/hr .Preoperatively oral gabapentin 600 mg will be given 1 hour prior to surgery .Erector spinae block is given at L2-3 vertebral level ,in plane technique in  a caudocranial direction .Hydro dissection is done to visualize  needle position deep to erector spinae muscle .After confirmation 40 ml of 0.25 % bupivacaine with 100 mcg/kg dexamethasone is injected bilaterally. Rescue  analgesia 0.5mg/kg ketamine is used intraoperatively if HR>20 % baseline and MAP>20% baseline .

The outcome variables and their measures

intraoperatively

1)Hemodynamic parameters -HR .Blood pressure (SBP,DBP,MAP),SPO2 is monitored every 15 min until end of surgery

2)Total rescue analgesic (IV Ketamine)consumed at the end of surgery

30Total analgesic consumption of the study drugs

Postoperatively

4)Severity of pain by using  NRS score both at rest and movement on arrival to PACU,20 min ,discharge from PACU ,2 hsr,4hrs,8hrs,12hrs and 24hrs

5)Side effects like PONV ,sedation ,respiratory depression (respiratory rate<8) and desaturation (spo2<94%)on arrival to PACU ,20 min, discharge  from PACU ,2hrs,4hrs,,8hrs,12hrs,24hrs.

6)Total dose of IV PCA Fentanyl used at end of 24 hrs

Descriptive and informative statistical analysis will be tabulated .Results on continues measurements are presented as Mean+\_ SD Results on categorical measurements will be presented as number (%).Analysis of variance (ANOVA) will be used to find the significance of study parameters between the two groups of patients. Study ’t’ test will be used to find the significance of study parameters on continues scale within each group.Chi square /Fischer Exact test will be used to find significance of study parameters on categorical scale within two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-26
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

All ASA I and II adult patients aged 18 years to 80 years posted for lumbar spine surgeries.

Exclusion Criteria

1.Pregnant and lactating women 2.Patients with intellectual disability ,dementia and alzheimer’s disease 3.Known history of hypersensitivity to local anesthetic agents 4.Coagulopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess duration of analgesia between the two groups (Lignocaine vs Dexmedetomidine) in the postoperative period	Duration of analgesia:Time from stop of study drug to first request of analgesia

Secondary Outcome Measures

Name	Time	Method
To assess the hemodynamic parameters such as heart rate, Systolic blood pressure(SBP), Diastolic blood pressure(DBP) and Mean arterial pressure (MAP) and Saturation (SpO2) intraoperatively between the two groups	Hemodynamic parameters -HR, Blood pressure (SBP, DBP and MAP), SpO2 is monitored every 15 min until end of surgery.
To assess the total rescue analgesic (Ketamine) consumed between the two groups	Total rescue analgesic ( IV Ketamine) consumed at the end of surgery
To assess total analgesic consumption of lignocaine and dexmedetomidine.	Total analgesic consumption of the study drugs.(lignocaine and dexmedetomidine)
To compare side effects between the two drugs.	Side effects like PONV, sedation, respiratory depression (Respiratory rate8) and Desaturation (SpO294%) on arrival to PACU, 20min, discharge from PACU, 2hrs,4hrs, 8hrs,12hrs and 24 hrs
To assess the total dose of rescue analgesia used postoperatively between the two groups	Total dose of IV PCA Fentanyl used at the end of 24 hrs
To assess NRS score at rest & movement	PACU at 20 min, discharge from PACU 2hrs,4hrs,8hrs,12hrs & 24hrs

Trial Locations

Locations (1)

St Johns Medical College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

St Johns Medical College and Hospital

🇮🇳Bangalore, KARNATAKA, India

Remya Santhosh

Principal investigator

9526034676

remya1794@gmail.com