Opioid PrEscRiptions and Usage After Surgery (OPERAS): Protocol for a Prospective Multicentre Observational Cohort Study of Opioid Use After Surgery

Overview

Journal BMJ Open

Specialty General Medicine

Date 2022 Nov 4

PMID 36332960

Affiliations

Soon will be listed here.

Abstract

Introduction: Postoperative pain is common and frequently addressed through opioid analgesia. This practice must balance the benefits of achieving adequate pain relief against the harms of adverse effects such as opioid-induced ventilatory impairment and opioid use disorder. This student and trainee-led collaborative study aims to investigate and compare the prescription versus consumption of opioids at 7 days postdischarge after common surgical procedures and their impact on patient-reported outcomes regarding postoperative pain.

Methods And Analysis: This is a prospective multicentre observational cohort study of surgical patients in Australia, Aotearoa New Zealand and select international sites, conducted by networks of students, trainees and consultants. Consecutive adult patients undergoing common elective and emergency general, orthopaedic, gynaecological and urological surgical procedures are eligible for inclusion, with follow-up 7 days after hospital discharge. The primary outcome will be the proportion of prescribed opioids consumed by patients at 7 days postdischarge. Secondary outcomes will include patient-reported quality of life and satisfaction scores, rate of non-opioid analgesic use, rate of continuing use of opioids at follow-up, rates of opioid prescription from other sources and hospital readmissions at 7 days postdischarge for opioid related side-effects or surgery-related pain. Descriptive and multivariate analyses will be conducted to investigate factors associated with opioid requirements and prescription-consumption discrepancies.

Ethics And Dissemination: OPERAS has been approved in Australia by the Hunter New England Human Research Ethics Committee (Protocol 2021/ETH11508) and by the Southern Health and Disability Ethics Committee (2021 EXP 11199) in Aotearoa New Zealand. Results will be submitted for conference presentation and peer-reviewed publication. Centre-level data will be distributed to participating sites for internal audit.

Trial Registration Number: ANZCTR (ID: ACTRN12621001451897p).

Citing Articles

Impact of opioid-free analgesia on pain severity and patient satisfaction after discharge from surgery: multispecialty, prospective cohort study in 25 countries.

Br J Surg. 2024; 111(1).

PMID: 38207169 PMC: 10783642. DOI: 10.1093/bjs/znad421.

Acute Pain and Development of Opioid Use Disorder: Patient Risk Factors.

Baumann L, Bello C, Georg F, Urman R, Luedi M, Andereggen L Curr Pain Headache Rep. 2023; 27(9):437-444.

PMID: 37392334 PMC: 10462493. DOI: 10.1007/s11916-023-01127-0.

References

Hopkins R, Bui T, Konstantatos A, Arnold C, Magliano D, Liew D . Educating junior doctors and pharmacists to reduce discharge prescribing of opioids for surgical patients: a cluster randomised controlled trial. Med J Aust. 2020; 213(9):417-423. DOI: 10.5694/mja2.50812. View

Allen M, Leslie K, Parker A, Kim C, Brooks S, Braat S . Post-surgical opioid stewardship programs across Australia and New Zealand: Current situation and future directions. Anaesth Intensive Care. 2019; 47(6):548-552. DOI: 10.1177/0310057X19880904. View

Riley R, Ensor J, Snell K, Harrell Jr F, Martin G, Reitsma J . Calculating the sample size required for developing a clinical prediction model. BMJ. 2020; 368:m441. DOI: 10.1136/bmj.m441. View

Harris P, Taylor R, Minor B, Elliott V, Fernandez M, ONeal L . The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019; 95:103208. PMC: 7254481. DOI: 10.1016/j.jbi.2019.103208. View

Levy N, Quinlan J, El-Boghdadly K, Fawcett W, Agarwal V, Bastable R . An international multidisciplinary consensus statement on the prevention of opioid-related harm in adult surgical patients. Anaesthesia. 2020; 76(4):520-536. DOI: 10.1111/anae.15262. View

. Postoperative variations in anaemia treatment and transfusions (POSTVenTT): protocol for a prospective multicentre observational cohort study of anaemia after major abdominal surgery. Colorectal Dis. 2021; 24(2):228-234. DOI: 10.1111/codi.15902. View

Riley R, Snell K, Ensor J, Burke D, Harrell Jr F, Moons K . Minimum sample size for developing a multivariable prediction model: Part I - Continuous outcomes. Stat Med. 2018; 38(7):1262-1275. DOI: 10.1002/sim.7993. View

Shafi S, Collinsworth A, Copeland L, Ogola G, Qiu T, Kouznetsova M . Association of Opioid-Related Adverse Drug Events With Clinical and Cost Outcomes Among Surgical Patients in a Large Integrated Health Care Delivery System. JAMA Surg. 2018; 153(8):757-763. PMC: 6142954. DOI: 10.1001/jamasurg.2018.1039. View

Bhangu A, Kolias A, Pinkney T, Hall N, Fitzgerald J . Surgical research collaboratives in the UK. Lancet. 2013; 382(9898):1091-2. DOI: 10.1016/S0140-6736(13)62013-9. View

10.

Gan T . Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017; 10:2287-2298. PMC: 5626380. DOI: 10.2147/JPR.S144066. View

11.

Kaafarani H, Han K, El Moheb M, Kongkaewpaisan N, Jia Z, El Hechi M . Opioids After Surgery in the United States Versus the Rest of the World: The International Patterns of Opioid Prescribing (iPOP) Multicenter Study. Ann Surg. 2020; 272(6):879-886. DOI: 10.1097/SLA.0000000000004225. View

12.

Vowles K, McEntee M, Julnes P, Frohe T, Ney J, van der Goes D . Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain. 2015; 156(4):569-576. DOI: 10.1097/01.j.pain.0000460357.01998.f1. View

13.

Kharasch E, Brunt L . Perioperative Opioids and Public Health. Anesthesiology. 2016; 124(4):960-5. DOI: 10.1097/ALN.0000000000001012. View

14.

Arwi G, Schug S . Potential for Harm Associated with Discharge Opioids After Hospital Stay: A Systematic Review. Drugs. 2020; 80(6):573-585. DOI: 10.1007/s40265-020-01294-z. View

15.

Brat G, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M . Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018; 360:j5790. PMC: 5769574. DOI: 10.1136/bmj.j5790. View

16.

Howard R, Fry B, Gunaseelan V, Lee J, Waljee J, Brummett C . Association of Opioid Prescribing With Opioid Consumption After Surgery in Michigan. JAMA Surg. 2018; 154(1):e184234. PMC: 6439853. DOI: 10.1001/jamasurg.2018.4234. View

17.

. Trainee- and student-led research networks: promoting research skills and competency through collaboration. ANZ J Surg. 2020; 90(11):2177-2179. DOI: 10.1111/ans.16333. View

18.

Bhadelia A, De Lima L, Arreola-Ornelas H, Kwete X, Rodriguez N, Knaul F . Solving the Global Crisis in Access to Pain Relief: Lessons From Country Actions. Am J Public Health. 2018; 109(1):58-60. PMC: 6301382. DOI: 10.2105/AJPH.2018.304769. View

19.

. Management of COMPlicAted intra-abdominal collectionS after colorectal Surgery (COMPASS): protocol for a multicentre, observational, prospective international study of drain placement practices in colorectal surgery. Colorectal Dis. 2020; 22(12):2315-2321. DOI: 10.1111/codi.15275. View

20.

Chan A, Tetzlaff J, Altman D, Laupacis A, Gotzsche P, Krleza-Jeric K . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; 158(3):200-7. PMC: 5114123. DOI: 10.7326/0003-4819-158-3-201302050-00583. View