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Clinical Trials/CTRI/2018/11/016311
CTRI/2018/11/016311CompletedNot Applicable

COMPARATIVE EVALUATION OF POST OPERATIVE ANALGESIC EFFECTS OF WOUND INFILTRATION WITH ROPIVACAINE VERSUS LEVOBUPIVACAINE IN MODIFIED RADICAL MASTECTOMY.

Department of Anesthesiology kidwai Cancer Institute1 site in 1 country60 target enrollmentStarted: November 21, 2018Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Analgesic efficacy VAS scale

Study Overview

Brief Summary

Adequate post operative analgesia with minimal side effects is  major concern of post anaesthesia care.

Ropivacaine  known to be significantly lower toxic effect than racemic Bupivacaine, it is less potent than Bupivacaine when used at equal concentration.

Levobupivacine the s enantiomer of racemic Bupivacaine is associated with greater safety with regard to cardiotoxic and neurotoxicity. It is also found that it is equipotent to racemic Bupivacaine.

This prospective study is proposed to compare analgesic efficacy  in modified radical mastectomy.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 65.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • ASA 1 and 2 Consenting patient Weight 50-70kg.

Exclusion Criteria

  • Patient refusal History of allergy Severe renal liver cardiac and pulmonary dysfunction Unable to comprehend VAS scale.

Outcomes

Primary Outcomes

Analgesic efficacy VAS scale

Time Frame: Post operatively 0min, 15min, 30min, 45min, 60min,90min,2,4,8,12,16,20 and 24hours.

Secondary Outcomes

  • Requirements of rescue analgesia(Incidence and severity of side effect)

Investigators

Sponsor
Department of Anesthesiology kidwai Cancer Institute
Sponsor Class
Research institution and hospital

Study Sites (1)

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