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The Efficacy of 20 mg Parecoxib as an Adjunct to 0.75% Ropivacaine in Supraclavicular Brachial Plexus Block for Upper Limb Surgery

NCT03480165 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2018-03-29

No results posted yet for this study

Summary

This clinical trial aims to investigate the efficacy of 20 mg Parecoxib when it is given as an addition to 20 ml 0.75% ropivacaine in patients receiving ultrasound-guided supraclavicular brachial plexus block prior to the upper limb surgeries. It is hypothesised that the addition of parecoxib to ropivacaine will provide superior sensory and motor blockades to those who only received 0.75% ropivacaine.

Eighty six (n=86) patients were randomised in one-to-one ratio to either receiving 20 mg parecoxib and 20 ml 0.75% ropivacaine (n=43) or 20 ml 0.75% ropivacaine and 1 ml 0.9% saline (n=43). The primary efficacy outcomes of interest are a) The time to onsets of sensory and motor blockades (measured in minutes); b) The time to recovery from sensory and motor blockades (measured in hours). The secondary efficacy outcomes of interest are a) The presence of complete sensory blockade at 30 minutes post intervention (recorded as a binary yes-no categorical variable); b) The presence of complete motor blockade at 30 minutes post intervention (recorded as a binary yes-no categorical variable).

Conditions

  • Anesthesia; Functional
  • Anesthesia

Interventions

DRUG

Parecoxib 20 MG/ML

1 ml of injectable parecoxib (Dynastat®, Pfizer) at a concentration of 20 mg/mL is given concurrently with 19 ml of 0.75% ropivacaine (Naropin®, Astra Zeneca)

DRUG

Ropivacaine

19 ml of 0.75% ropivacaine (Naropin®, Astra Zeneca)) is given concurrently with 1 ml of normal saline

Sponsors & Collaborators

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Vivekananda Gunasekaran, MBBS · Universiti Sains Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-20
Primary Completion
2017-09-19
Completion
2017-09-19

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03480165 on ClinicalTrials.gov