None listed
Conditions
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.
Interventions
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 i
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.
Sponsors
Te Whatu Ora Waitemata
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 18 to 65 years Undergoing elective bariatric surgery Able to provide informed consent
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
Outcome results
None listed