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Clinical Trials/CTRI/2019/03/018170
CTRI/2019/03/018170CompletedPhase 4

A Randomized Clinical Trial Comparing 0.75% Ropivacaine And 2% Lignocaine With 1 : 200000 Adrenaline In Minor Oral Surgery.

Vishwajeet Singh Jamwal1 site in 1 country128 target enrollmentStarted: March 20, 2019Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
128
Locations
1
Primary Endpoint
Onset and duration of anesthesia and analgesia, Cardiovascular effects,VAS pain score.

Study Overview

Brief Summary

Ropivacaine hydrochloride being a long acting amide  local anesthetic having long duration ( 6-7 hours) of action can be beneficial in minor oral surgical procedures like surgical extraction of impacted teeth , enucleation of small cysts ,fracture reduction ,intermaxillary fixation etc.These procedures are routinely carried out under local anesthesia but require repeated infiltration or nerve blocks with more conventional drug i.e Lignocaine hydrochloride with 1:200000 adrenaline having moderate duration of action ranging from 120-150 minutes. In patients with CVS problems in whom adrenaline is contraindicated and plain Lignocaine without vasoconstrictor fails to provide effective anesthesia for required duration , Ropivacaine hydrochloride can provide effective anesthesia.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
14.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients not receiving any medications that will alter the perception of pain.
  • Patients requiring extraction of bilaterally symmetrical teeth.

Exclusion Criteria

  • 1.Patients with history of allergic reactions to LA of amide group and sulfides.
  • 2.Patients with acute infections.
  • 3.Patients taking medications like MAO inhibitors, tricyclic antidepressants , phenothiazines ,vasodepressor drugs 4.Pregnant and lactating patients.

Outcomes

Primary Outcomes

Onset and duration of anesthesia and analgesia, Cardiovascular effects,VAS pain score.

Time Frame: Preoperatively, | Intraoperatively at 5 minutes interval and postoperatively as required.

Secondary Outcomes

  • Number of additional blocks /infiltration required or any other adverse effect.

Investigators

Sponsor
Vishwajeet Singh Jamwal
Sponsor Class
Other [self]

Study Sites (1)

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