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Deep and slow breathing in postsurgical abdominal pain management: an explorative study

Deep and slow breathing in postsurgical abdominal pain management: an explorative study - Deep breathing after major abdominal surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43878
Enrollment
40
Registered
2015-03-10
Start date
2016-02-02
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pijn na buik chirurgie (abdominal) pain after surgery Postsurgical (abdominal) pain

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Patient is at least 18 years old on the day the informed consent form will be signed. 2.Patient is undergoing elective major abdominal surgery. 3.The surgical procedure has an estimated duration of at least 90 minutes, excluding the time to induce anesthesia. 4.Patient scores I to III in the American Society of Anesthesiologists physical status classification system (ASA I-III). 5.Patient is willing and able to comply with the trial protocol. 6.Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe chronic obstructive or another pulmonary disease that impairs patient from practicing deep and slow breathing 2.Patient has (a history of) a (chronic) pain syndrome that interferes with the interpretation of QST results. 3.Patient has (a history of) Raynaud syndrome or fenomenon, or a medical disorder that interferes with the study measurements or may pose a risk for the patient. 4.Patient does not feel a pinprick test to the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus). 5.Female patient is pregnant during the course of the study. 6.Patient is allergic to white plasters. 7. Any condition that disables the patient to make an independent transfer from bed to chair, e.g. being wheelchair bound.

Design outcomes

Primary

MeasureTime frame
The primary study outcome is the Visual Analogue Scale pain score (VAS) during mobilization on the third postoperative day.

Secondary

MeasureTime frame
Other parameters are: VAS during mobilization on the fourth postoperative day before intervention, VAS pain scores in rest before and after intervention, quantitative sensory testing and conditioned pain modulation parameters, cytokine and cortisol response and outcomes of pain-related psychological questionnaires (PCS, PASS and STAI). Adverse events and feasibility (MTSQ).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)