NCT03480165

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

March 6, 2018

Last Update Submit

March 20, 2018

Conditions

Anesthesia; FunctionalAnesthesia

Keywords

Randomized controlled trialDouble blindParallel group

Outcome Measures

Primary Outcomes (4)

  • Sensory block onset

    Time (measured in minutes) required for a 30% decrease in sensation compared to the contralateral upper limb limb as a reference

    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)

  • Motor block onset

    Time (measured in minutes) from the injection of interventions until a decrease in motor power to at least grade 3

    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 duration

    The time (measured in hours) from the injection of interventions until complete recovery in cold and pain sensation confirmed by alcohol swab and pin prick tests in all respective dermatomes of the brachial plexus (C5-T1)

    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 duration

    Time (measured in hours) from the injection of allotted interventions until complete recovery of motor power (grade 1) in all dermatomes supplied by brachial plexus (C5-T1)

    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]

Secondary Outcomes (2)

  • Complete sensory blockade at 30 minutes post interventions

    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

    Measured at 30 minutes post intervention and recorded as a binary categorical variable (yes or no)

Study Arms (2)

20 mg Parecoxib + 0.75% Ropivacaine

EXPERIMENTAL

1 ml of 20 mg Parecoxib is given concurrently with 19 mls of 0.75% ropivacaine

Drug: Parecoxib 20 MG/MLDrug: Ropivacaine

0.75% Ropivacaine only

ACTIVE COMPARATOR

19 ml of Ropivacaine at a concentration of 0.75% is given concurrently with 1 ml of 0.9% saline

Drug: Ropivacaine

Interventions

Parecoxib 20 MG/MLDRUG

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)

Also known as: Dynastat® (Pfizer)
20 mg Parecoxib + 0.75% Ropivacaine
RopivacaineDRUG

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

Also known as: Naropin® (Astra Zeneca)
0.75% Ropivacaine only20 mg Parecoxib + 0.75% Ropivacaine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anaesthesiology Physical Status Gred 1 and 2
  • Expected duration of surgery is between 1 and 4 hours

You may not qualify if:

  • Subjects who refused brachial plexus block
  • Know allergies to parecoxib, other NSAID and anaesthetic agents
  • Pregnancy
  • Prior history of brachial plexus injury
  • Chronic pain history which long term use of analgesic medications
  • Coagulopathy
  • Systemic or local infection at the injection site
  • Known neuropathy affecting the limb which undergo the surgical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universiti Sains Malaysia (HUSM)

Kubang Kerian, Kelantan, 15350, Malaysia

Location

Related Publications (9)

  • Liu X, Zhao X, Lou J, Wang Y, Shen X. Parecoxib added to ropivacaine prolongs duration of axillary brachial plexus blockade and relieves postoperative pain. Clin Orthop Relat Res. 2013 Feb;471(2):562-8. doi: 10.1007/s11999-012-2691-y. Epub 2012 Nov 21.

    PMID: 23179117BACKGROUND

  • Little RAJ, Rubin DB (2002). Statistical analysis with missing data. 2nd edition.John Wiley and Sons; Hoboken, New Jersey. ISBN: 978-0-471-18386-0

    BACKGROUND

  • Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009 Jun 29;338:b2393. doi: 10.1136/bmj.b2393.

    PMID: 19564179BACKGROUND

  • Jain KK. Evaluation of intravenous parecoxib for the relief of acute post-surgical pain. Expert Opin Investig Drugs. 2000 Nov;9(11):2717-23. doi: 10.1517/13543784.9.11.2717.

    PMID: 11060833BACKGROUND

  • Amabile CM, Spencer AP. Parecoxib for parenteral analgesia in postsurgical patients. Ann Pharmacother. 2004 May;38(5):882-6. doi: 10.1345/aph.1D283. Epub 2004 Mar 23.

    PMID: 15039473BACKGROUND

  • Ammar AS, Mahmoud KM. Ultrasound-guided single injection infraclavicular brachial plexus block using bupivacaine alone or combined with dexmedetomidine for pain control in upper limb surgery: A prospective randomized controlled trial. Saudi J Anaesth. 2012 Apr;6(2):109-14. doi: 10.4103/1658-354X.97021.

    PMID: 22754434BACKGROUND

  • Borgeat A, Ekatodramis G, Dumont C. An evaluation of the infraclavicular block via a modified approach of the Raj technique. Anesth Analg. 2001 Aug;93(2):436-41, 4th contents page. doi: 10.1097/00000539-200108000-00040.

    PMID: 11473876BACKGROUND

  • Duma A, Urbanek B, Sitzwohl C, Kreiger A, Zimpfer M, Kapral S. Clonidine as an adjuvant to local anaesthetic axillary brachial plexus block: a randomized, controlled study. Br J Anaesth. 2005 Jan;94(1):112-6. doi: 10.1093/bja/aei009. Epub 2004 Oct 29.

    PMID: 15516351BACKGROUND

  • Crews JC, Weller RS, Moss J, James RL. Levobupivacaine for axillary brachial plexus block: a pharmacokinetic and clinical comparison in patients with normal renal function or renal disease. Anesth Analg. 2002 Jul;95(1):219-23, table of contents. doi: 10.1097/00000539-200207000-00039.

    PMID: 12088972BACKGROUND

Related Links

MeSH Terms

Interventions

parecoxibRopivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Vivekananda Gunasekaran, MBBS

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 29, 2018

Study Start

June 20, 2016

Primary Completion

September 19, 2017

Study Completion

September 19, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

All individual participant data (IPD) will be shared with other researchers. These include all primary and secondary outcomes of interest and covariate information which include the clinical and demographic profiles of patients.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The IPD are now available and will be shared with other researchers upon request. There is no time restriction and the IPD will be deposited in the database of a journal in which the results will be published.
Access Criteria
Data request will be shared upon request to the primary investigator (Vivekananda Gunasekaran;drvivek\ ananda@yahoo.com) or back up investigator (Muhammad Irfan bin Abdul Jalal, muhammadirfan1504@gmail.com)

Locations

MY(1)