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Trial registered on ANZCTR
Registration number
ACTRN12626000690358p
Ethics application status
Not yet submitted
Date submitted
16/05/2026
Date registered
10/06/2026
Date last updated
10/06/2026
Date data sharing statement initially provided
10/06/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of COX-2 inhibitor (parecoxib) versus placebo on opioid pain medication use after bariatric surgery: a randomised controlled trial
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Scientific title
Short-Term COX-2 Inhibitors for Postoperative Analgesia in Bariatric Surgical Patients: A Triple-Blind Randomized Placebo-Controlled Trial Assessing Postoperative Opioid Requirements and Recovery Outcomes
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Additional trial identifiers [1]
317257
0
WAI20482
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Obesity
341953
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Postoperative pain following bariatric surgery
341954
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Condition category
Condition code
Diet and Nutrition
338028
338028
0
0
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Obesity
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Anaesthesiology
338029
338029
0
0
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Pain management
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Surgery
338030
338030
0
0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
Intervention group (parecoxib): Participants undergoing elective bariatric surgery will receive intravenous parecoxib in addition to standard postoperative analgesia. The intervention consists of:
Parecoxib 40 mg IV immediately postoperatively (40 mg reconstituted in 2 mL solution)
Parecoxib 20 mg IV at 10 hours postoperatively (20 mg in 2 mL solution)
Parecoxib 20 mg IV at 20 hours postoperatively (20 mg in 2 mL solution)
Study medication will be prepared in identical blinded syringes by an independent anaesthetist not involved in patient care or outcome assessment. Dose 1 will be administered by the treating anaesthetist immediately after surgery. Doses 2 and 3 will be administered by ward nursing staff according to the study protocol.
All participants will continue to receive routine multimodal postoperative analgesia, including paracetamol and opioid analgesia as clinically required.
Adherence will be monitored through medication administration records and study case report forms documenting administration of each scheduled dose.
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Intervention code [1]
334089
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Treatment: Drugs
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Intervention code [2]
334090
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Treatment: Other
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Description of the comparator or control
Control group (placebo): Participants undergoing elective bariatric surgery will receive placebo injections in addition to standard postoperative analgesia. The placebo consists of:
2 mL 0.9% sodium chloride IV immediately postoperatively
2 mL 0.9% sodium chloride IV at 10 hours postoperatively
2 mL 0.9% sodium chloride IV at 20 hours postoperatively
Placebo syringes will be identical in appearance to the intervention syringes and prepared by an independent anaesthetist not involved in patient care or outcome assessment.
All participants will continue to receive routine multimodal postoperative analgesia, including paracetamol and opioid analgesia as clinically required, according to standard bariatric perioperative care pathways at Te Whatu Ora Waitemata.
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Control group
Placebo
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Outcomes
Primary outcome [1]
345438
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Total postoperative opioid requirement measured as cumulative morphine equivalent consumption within 48 hours after surgery.
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Assessment method [1]
345438
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Measured using inpatient medication administration records and converted to total morphine milligram equivalents (MME).
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Timepoint [1]
345438
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48 hours postoperatively.
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Secondary outcome [1]
461658
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Postoperative pain
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Assessment method [1]
461658
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Visual Analogue Scale pain score
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Timepoint [1]
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12, 24, and 48 hours postoperatively
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Secondary outcome [2]
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Quality of recovery
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Assessment method [2]
461659
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Quality of Recovery-15 questionnaire
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Timepoint [2]
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24 and 48 hours postoperatively
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Secondary outcome [3]
461660
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Patient global evaluation of recovery
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Assessment method [3]
461660
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Patient global evaluation score questionnaire
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Timepoint [3]
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48 hours postoperatively
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Secondary outcome [4]
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Opioid-related side effects
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Assessment method [4]
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Opioid Side Effect Scale questionnaire
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Timepoint [4]
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2, 24, and 48 hours postoperatively
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Secondary outcome [5]
461662
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Postoperative complications (composite outcome comprising bleeding, anastomotic leak, nausea, vomiting, dyspepsia, acute kidney injury, and major cardiovascular events). All post-operative complications will be assessed as a composite secondary outcome.
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Assessment method [5]
461662
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Clinical assessment and medical record review
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Timepoint [5]
461662
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During inpatient admission and within 3 months postoperatively
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Secondary outcome [6]
461663
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Length of hospital stay
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Assessment method [6]
461663
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Hospital admission and discharge records
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Timepoint [6]
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At hospital discharge
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Eligibility
Key inclusion criteria
Adults aged 18 to 65 years
Undergoing elective bariatric surgery
Able to provide informed consent
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Pre-existing gastric ulcer or gastritis
History of NSAID-induced gastrointestinal bleeding
Chronic NSAID use within 30 days preoperatively
Severe renal or hepatic impairment
Clotting disorders
Known allergy to NSAIDs or salicylates
History of chronic pain disorders
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by an independent trial coordinator not involved in patient care or outcome assessment. Allocation information will be concealed from participants, treating clinicians, and outcome assessors using identical blinded syringes prepared by an independent anaesthetist.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with 1:1 allocation to intervention and placebo groups. The randomisation sequence will be generated and maintained centrally by an independent trial coordinator.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2026
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
174
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
28107
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New Zealand
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State/province [1]
28107
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Funding & Sponsors
Funding source category [1]
321831
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Hospital
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Name [1]
321831
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Te Whatu Ora Waitemata
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Address [1]
321831
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Country [1]
321831
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New Zealand
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Primary sponsor type
Hospital
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Name
Te Whatu Ora Waitemata
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Address
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Country
New Zealand
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Secondary sponsor category [1]
324683
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None
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Name [1]
324683
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Address [1]
324683
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Country [1]
324683
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
320373
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
320373
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
320373
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New Zealand
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Date submitted for ethics approval [1]
320373
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22/06/2026
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Approval date [1]
320373
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Ethics approval number [1]
320373
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Summary
Brief summary
This study will investigate whether short-term use of the COX-2 inhibitor parecoxib can safely reduce opioid pain medication requirements following bariatric surgery. Participants undergoing elective bariatric surgery will be randomly assigned to receive either intravenous parecoxib or placebo in addition to standard postoperative pain management. The study will assess postoperative opioid use, pain scores, quality of recovery, medication side effects, complications, and length of hospital stay. The aim is to determine whether perioperative parecoxib improves postoperative recovery while reducing opioid exposure and opioid-related side effects following bariatric surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
150266
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Mr Suheelan Kulasegaran
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Address
150266
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Department of Surgery, North Shore Hospital, Te Whatu Ora Waitemata, 124 Shakespeare Road, Takapuna, Auckland 0740, New Zealand
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Country
150266
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New Zealand
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Phone
150266
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+64 212890715
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Fax
150266
0
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Email
150266
0
[email protected]
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Contact person for public queries
Name
150267
0
Suheelan Kulasegaran
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Address
150267
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Department of Surgery, North Shore Hospital, Te Whatu Ora Waitemata, 124 Shakespeare Road, Takapuna, Auckland 0740, New Zealand
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Country
150267
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New Zealand
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Phone
150267
0
+64 212890715
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Fax
150267
0
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Email
150267
0
[email protected]
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Contact person for scientific queries
Name
150268
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Suheelan Kulasegaran
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Address
150268
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Department of Surgery, North Shore Hospital, Te Whatu Ora Waitemata, 124 Shakespeare Road, Takapuna, Auckland 0740, New Zealand
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Country
150268
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New Zealand
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Phone
150268
0
+64 212890715
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Fax
150268
0
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Email
150268
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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