Effect Of Dexmedetomidine An Analgesic Drug As An Additive In Errector Spinae Plane Block In Spine Surgery

Phase 4

Not yet recruiting

• Conditions: Acquired deformity of musculoskeletal system, unspecified,

• Registration Number: CTRI/2022/01/039431
• Lead Sponsor: PGIMER CHANDIGARH

Brief Summary

Opioid Free Anaesthesia (OFA) is a multimodal nonopioid analgesic technique wherein use of opioids in any form is completely eliminated during anaesthesia. This  new concept has emerged secondary to potential adverse effects of opioids.In light of the known adverse effects, there have been concerted efforts to reduce opioid exposure by utilising the non-opioid based alternatives analgesic techniques. These non-opioid based techniques are either administered systemically or at nerve root levels.Ketamine is a well-established anaesthetic agent which acts as NMDA receptor in addition to opioid receptors. It provides intense analgesia by reducing glutamate release due to its antagonist action on NMDA receptors and by binding to sigma-opioid receptors. Subanaesthetic doses of ketamine (0.5 mg/kg or less) is very effective in reducing postoperative pain score.Few studies have documented use of ESP block  in spine surgery and observed lower pain scores postoperatively in ESP block group compared with systemic opioids. Dexmedetomidine, an alfa 2 receptors agonist, produces analgesia by acting on locus ceruleus of central nervous system and on both presynaptic and postsynaptic alfa 2 receptors at peripheral nervous system.We hypothesize that the addition of dexmedetomidine to local anaesthetic agent (ropivacaine) as an adjuvant in the ESP block will increase the duration of postoperative analgesia in spine surgery in ketamine based OFA technique.In this study, the effect of dexmedetomidine will be assessed as an adjuvant to ropivacaine in ESP block in thoracolumbar spine surgery done under ketamine based OFA on postoperative pain management.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-02
• Last Update Posted: 2022-10-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1. Age :18-65 years 2) Male/female 3) ASA 1 and 2 4) Patient posted for lower thoracic and upper lumber spine surgery (T8-L3) involving 2-4 intervertebral spaces.
• 5. Nontraumatic cases and Traumatic cases with no other skeletal trauma 6) Patient able to grade severity of pain.

Exclusion Criteria

• 1. Preoperative pain score more than or equal to 5 2) BMI>35kg/m2 3) Pregnant or lactating woman 4) Patient with CAD/bradycardia/heart block/arrhythmias 5) Patient with hepatic/renal failure /CNS pathology 6) Patient with psychiatric disorder.
• 7. Patient not able to assess and tell severity of pain 8) Patients with allergies to any study medication.
• 9. Inability to position patient for block 10) ASIA A spine injury.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare duration of pain free period postoperatively in patients receiving ESP block with ropivacaine and dexmedetomidine Vs ropivacaine alone.	1) postoperative pain scores at 0,2,4,6,8,12 and 24 hrs | 2) rescue analgesic requirements during first 24 hour after surgery.

Secondary Outcome Measures

Name	Time	Method
1.To compare postoperative pain scores at 0,2,4,6,8,12 and 24 hrs	2.To compare rescue analgesic requirements during first 24 hour after surgery.

Trial Locations

Locations (1)

NEUROSURGERY OT AND WARD; 🇮🇳 Chandigarh, CHANDIGARH, India

NEUROSURGERY OT AND WARD

🇮🇳Chandigarh, CHANDIGARH, India

SWATI VERMA

Principal investigator

9896818470

swativerma962@gmail.com