Comparing pain relieving potential of giving Dexamethasone or Dexmedetomidine or Ketamine when given with 0.375% Ropivacaine for ultrasound guided erector spinae block in spinal surgery for pain relief

Completed

• Conditions: Joint disorder, unspecified,

• Registration Number: CTRI/2023/09/057570
• Lead Sponsor: Institute of Neurosciences Kolkata

Brief Summary

Pain is main concern for all patients undergoing surgery. Drugs like benzodiazepines (like Midazolam, Diazepam) and opioids (like Fentanyl) have been used with their known side effects. Enhanced Recovery After Anaesthesia (ERAS) emphasizes the use of regional anaesthesia for postoperative analgesia with the goal of it being opioid free. Erector spinae plane block (ESPB) is a novel regional anaesthesia technique, which is a useful intervention in thoracic neuropathic pain and acute pain after surgery. The placement of local anaesthetics only in the interfacial plane for the block has been well established since its inception of use in pain management. However, to further the duration of analgesia additives are being deposited perineural along with local anesthetics. Perineurally deposited dexmedetomidine, dexamethasone and ketamine has been historically in use for peripheral nerve blocks, which is now finding its place in truncal blocks. Thus, this study is being conducted to compare the efficacy of dexmedetomidine, dexamethasone and ketamine along with 0.375 % ropivacaine in erector spinae plane block to reduce postoperative pain in dorsolumbar spine surgeries.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-20
• Study Completion: 2024-09-15
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Aged 18–65 years ASA grade I, II Either gender BMI < 24 kg/m2 Surgical procedure: spinal instrumentation surgeries involving the dorso-lumbar spine (D10-S1) Duration of surgery: up to 4 hours.

Exclusion Criteria

Patient refusal ASA Grade III/ IV Surgeries: Scoliosis correction surgery Spinal instrumentation surgery planned under intraoperative neuro-monitoring Revision spine surgery Duration of surgery >4 hours, Patients with hypersensitivity to any of the drugs in use History of congestive heart failure/ valvular heart disease/ IHD/Â cardiac conduction block/ renal dysfunction/ hepatic disease/ pulmonary disease/ neuropsychiatric disorders/ coagulation abnormality Puncture site infection History of chronic pain or central neuropathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of duration of analgesia using VAS pain score	0 hr | 2 hr | 4 hr | 8 hr | 12 hr | 24 hr

Secondary Outcome Measures

Name	Time	Method
Total intraoperative and postoperative opioid consumption	24 hr
Intraoperative haemodynamic stability	10 min
First request of rescue analgesic	Anytime in first 24 hr
Occurrence of PONV in postoperative period	Anytime in first 24 hr

Trial Locations

Locations (1)

Institute of Neurosciences Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Institute of Neurosciences Kolkata

🇮🇳Kolkata, WEST BENGAL, India

Dr Eesha Banerjee

Principal investigator

7501724995

eesha5banerjee70@gmail.com