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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03480165
• Date of registration: 06/03/2018
• Prospective Registration: No
• Primary sponsor: Universiti Sains Malaysia
• Public title: The Efficacy of 20 mg Parecoxib as an Adjunct to 0.75% Ropivacaine in Supraclavicular Brachial Plexus Block for Upper Limb Surgery RCT
• Scientific title: A Randomized Two-parallel Group Controlled Trial Comparing the Effects of 20mg Parecoxib as an Adjunct to 0.75% Ropivacaine in Ultrasound-guided Supraclavicular Block for Upper Limb Surgery
• Date of first enrolment: June 20, 2016
• Target sample size: 86
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03480165
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Malaysia

Contacts

• Name: Vivekananda Gunasekaran, MBBS
• Affiliation: Universiti Sains Malaysia

Key inclusion & exclusion criteria

Inclusion Criteria:

1. American Society of Anaesthesiology Physical Status Gred 1 and 2

2. Expected duration of surgery is between 1 and 4 hours

Exclusion Criteria:

1. Subjects who refused brachial plexus block

2. Know allergies to parecoxib, other NSAID and anaesthetic agents

3. Pregnancy

4. Prior history of brachial plexus injury

5. Chronic pain history which long term use of analgesic medications

6. Coagulopathy

7. Systemic or local infection at the injection site

8. Known neuropathy affecting the limb which undergo the surgical procedures



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anesthesia; Functional

Anesthesia

Intervention(s)

Drug: Ropivacaine

Drug: Parecoxib 20 MG/ML

Primary Outcome(s)

Motor block duration [Time Frame: From complete administration of interventions via supraclavicular brachial plexus block until complete recovery of motor power (grade 1) in all dermatomes supplied by brachial plexus (C5-T1) [assessed half hourly, up to 12 hours post surgery]]

Sensory block duration [Time Frame: From complete institution of interventions via supraclavicular brachial plexus block until full recovery of sensation (cold and pain) (grade 0) in all dermatomes supplied by the brachial plexus (C5-T1) [assessed half hourly, up to 12 hours post surgery]]

Motor block onset [Time Frame: From complete administration of the allotted interventions via supraclavicular brachial plexus block until motor power was reduced to at least grade 3 (assessed every 5 minutes, up to 30 minutes)]

Sensory block onset [Time Frame: From complete adminstration of the allotted interventions via supraclavicular brachial plexus block until the occurrence of 30% decrease in sensation compared to the contralateral upper limb (assessed every 5 minutes, up to 30 minutes)]

Secondary Outcome(s)

Complete sensory blockade at 30 minutes post interventions [Time Frame: Measured at 30 minutes following post interventions and recorded as a binary categorical variable (yes or no)]

Complete motor blockade at 30 minutes post intervention [Time Frame: Measured at 30 minutes post intervention and recorded as a binary categorical variable (yes or no)]

Secondary ID(s)

USM/JEPeM/16010033

Source(s) of Monetary Support

Please refer to primary and secondary sponsors