Postoperative Nausea, Vomiting and Pain After Bariatric Surgery - a National Registry Study

NCT07797374 | Recruiting

• 3 other identifiers: BAROSPOR-2025-012025-00877-012025
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 2

Brief Summary

Around 4,000-5,000 bariatric (weight-loss) operations are performed in Sweden every year. Nausea, vomiting and pain are common immediately after these operations, cause considerable suffering and increase the intensity and length of hospital care. Bariatric surgery is one of the procedures with the highest risk of postoperative nausea and vomiting (PONV): about one third of patients experience PONV already in the recovery unit, and registry data indicate that around 40% report severe pain at the same stage. This study links two national quality registries - the Swedish Perioperative Register (SPOR) and the Scandinavian Obesity Surgery Registry (SOReg) - to describe how often adult patients experience nausea, vomiting and pain in the post-anaesthesia care unit after primary bariatric surgery, and to identify patient, anaesthetic and surgical factors associated with these outcomes. The study tests whether total intravenous anaesthesia, the addition of a regional nerve block, and preoperative health-related quality of life are associated with PONV and pain, and whether early PONV or pain is associated with complications, unplanned hospital care or reoperation up to one year after surgery. The results are intended to show how well current evidence on preventing PONV and pain is applied in everyday practice and where care can be improved.

Conditions

Postoperative Nausea and Vomiting; Obesity, Morbid; Postoperative Pain; Bariatric Surgery

Keywords

PONV; postoperative pain; anaesthesia; total intravenous anaesthesia; regional anaesthesia; bariatric surgery; quality registry; SPOR; SOReg; RAND-36

Outcome Measures

Primary Outcomes (3)

• Incidence of postoperative nausea and/or vomiting in the post-anaesthesia care unit

  Number of operations with registered nausea and/or vomiting in the PACU divided by the total number of operations. Source: SPOR variable "Illamående postoperativt" (postoperative nausea).

  During the stay in the post-anaesthesia care unit (approximately 0-4 hours after surgery)

• Pain intensity in the post-anaesthesia care unit, numerical rating scale (NRS) 0-10

  Median NRS score (0 = no pain, 10 = worst imaginable pain). Source: SPOR variables "Smärta inom 1 tim efter ankomst UVA" (pain within 1 hour of PACU arrival) and "Smärta postoperativt, högsta" (highest postoperative pain).

  During the stay in the post-anaesthesia care unit (approximately 0-4 hours after surgery)

• Incidence of severe pain in the post-anaesthesia care unit

  Number of operations with NRS \>= 7 divided by the total number of operations.

  During the stay in the post-anaesthesia care unit (approximately 0-4 hours after surgery)

Secondary Outcomes (2)

• Proportion of patients with postoperative complications, unplanned hospital care or reoperation - 6 weeks

  Up to 6 weeks after surgery

• Proportion of patients with postoperative complications, unplanned hospital care or reoperation - 1 year

  Up to 1 year after surgery

Study Arms (1)

Adults undergoing primary bariatric surgery in Sweden 2018-2027

Patients aged 18 years or older with a primary bariatric procedure registered in the Scandinavian Obesity Surgery Registry (SOReg) 2018-2027 and a matching operation record in the Swedish Perioperative Register (SPOR).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients registered in the Scandinavian Obesity Surgery Registry (SOReg) with a primary bariatric procedure during 2018-2027 and a matching operation record in the Swedish Perioperative Register (SPOR).

You may qualify if:

• Age 18 years or older
• Primary bariatric surgery registered in SOReg during 2018-2027

You may not qualify if:

• Revision bariatric surgery
• If more than one bariatric operation is registered for the same patient, only the primary operation is included

Sponsors & Collaborators

• Umeå University: lead
• Västernorrland County Council, Sweden: collaborator
• The Scandinavian Obesity Surgery Registry: collaborator

Study Sites (2)

Sundsvall Hospital, Department of Anaesthesia and Intensive Care

Sundsvall, 851 86, Sweden

RECRUITING

Umeå University, Department of Diagnostics and Intervention

Umeå, 901 87, Sweden

RECRUITING

Related Links

• Swedish Perioperative Register (SPOR)
• Scandinavian Obesity Surgery Registry (SOReg)

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative; Obesity, Morbid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Jakob Walldén, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Walldén, MD, PhD

CONTACT

+46 60 14 52 55; jakob.wallden@umu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior Consultant in Anaesthesia and Intensive Care

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)