A Study of the Association Between Frailty and Acute Postoperative Pain in Elderly Thoracoscopic Surgery Patients

NCT06281275 | Recruiting

• 1 other identifier: TJ-IRB202402008
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

To gain a clearer understanding of the association between frailty and postoperative acute pain in elderly thoracoscopic surgery patients and its underlying mechanisms, to provide new solution ideas to reduce the level of postoperative acute pain and improve the debilitating state of elderly thoracoscopic surgery patients, and consequently improve their quality of life and mental status.

Conditions

Frailty; Acute Postoperative Pain

Keywords

Frailty; Acute Postoperative Pain; Gastrointestinal Microbiome; Thoracoscopy

Outcome Measures

Primary Outcomes (2)

• All patients' Numerical Rating Scale （NRS） scores for most significant pain at rest in the 48h postoperative period

  Patients' pain levels were assessed using the Numerical Rating Scale （NRS） scale. This method is composed of a total of 11 numbers from 0 to 10, the patient with 0 to 10 of these 11 numbers to describe the intensity of pain, the greater the number of pain is increasingly serious. 0 no pain, 1 to 3 mild pain (pain does not affect sleep), 4 to 6 moderate pain, 7 to 6 pain is increasingly serious. The patient describes the intensity of pain using the 11 numbers from 0 to 10, the greater the number, the more severe the pain becomes. 0 no pain, 1-3 mild pain (pain that does not interfere with sleep), 4-6 moderate pain, 7-9 severe pain (inability to sleep or waking up from sleep with pain), and 10 severe pain.

  202402-2024-10

• Numerical Rating Scale （NRS） scores for the most pronounced pain in the patient's coughing state in the 48h postoperative period

  All patients' pain levels were assessed using the NRS scale. This method is composed of a total of 11 numbers from 0 to 10, the patient with 0 to 10 of these 11 numbers to describe the intensity of pain, the greater the number of pain is increasingly serious. 0 no pain, 1 to 3 mild pain (pain does not affect sleep), 4 to 6 moderate pain, 7 to 6 pain is increasingly serious. The patient describes the intensity of pain using the 11 numbers from 0 to 10, the greater the number, the more severe the pain becomes. 0 no pain, 1-3 mild pain (pain that does not interfere with sleep), 4-6 moderate pain, 7-9 severe pain (inability to sleep or waking up from sleep with pain), and 10 severe pain.

  202402-2024-10

Secondary Outcomes (2)

• PCA pump consumption

  202402-2024-10

• Number of PCA pump presses

  202402-2024-10

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is proposed to observe cases with age greater than or equal to 60 years undergoing thoracoscopic surgery at Tongji Hospital from February 2024 to October 2024 who meet the inclusion and exclusion criteria.

You may qualify if:

• patients undergoing thoracic surgery under general anesthesia with 48 h of postoperative patient-controlled analgesia;
• age ≥60 years;
• ASA class I-III;
• signed informed consent;
• patients undergoing thoracoscopic surgery.

You may not qualify if:

• Patients who themselves refuse to participate in the study;
• Drug dependence;
• Patients who cannot cooperate with communication and have verbal communication difficulties;
• Patients who cannot assess frailty preoperatively and pain postoperatively;
• Failure to provide a compliant fecal sample at the agreed time;
• antibiotic treatment within the last month;
• intestinal dysfunction (e.g., irritable bowel syndrome, inflammatory bowel disease, chronic diarrhea, and other types of intestinal disorders);
• comorbidities of certain metabolic disorders (e.g., thyroid dysfunction, diabetes mellitus, and so on) that may affect the structure of the microbial community;

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (8)

• Tanaka S, Kamiya K, Matsue Y, Yonezawa R, Saito H, Hamazaki N, Matsuzawa R, Nozaki K, Yamashita M, Wakaume K, Endo Y, Maekawa E, Yamaoka-Tojo M, Shiono T, Inomata T, Ako J. Efficacy and Safety of Acute Phase Intensive Electrical Muscle Stimulation in Frail Older Patients with Acute Heart Failure: Results from the ACTIVE-EMS Trial. J Cardiovasc Dev Dis. 2022 Mar 27;9(4):99. doi: 10.3390/jcdd9040099.

  PMID: 35448075 BACKGROUND

• Miyano T, Kaneko R, Kimura T, Maruoka M, Kishimura A, Kato K, Furuta M, Yamashita Y. Dietary Problems Are Associated with Frailty Status in Older People with Fewer Teeth in Japan. Int J Environ Res Public Health. 2022 Dec 5;19(23):16260. doi: 10.3390/ijerph192316260.

  PMID: 36498332 BACKGROUND

• Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.

  PMID: 23764209 BACKGROUND

• Gale CR, Cooper C, Sayer AA. Prevalence of frailty and disability: findings from the English Longitudinal Study of Ageing. Age Ageing. 2015 Jan;44(1):162-5. doi: 10.1093/ageing/afu148. Epub 2014 Oct 12.

  PMID: 25313241 BACKGROUND

• O'Caoimh R, Sezgin D, O'Donovan MR, Molloy DW, Clegg A, Rockwood K, Liew A. Prevalence of frailty in 62 countries across the world: a systematic review and meta-analysis of population-level studies. Age Ageing. 2021 Jan 8;50(1):96-104. doi: 10.1093/ageing/afaa219.

  PMID: 33068107 BACKGROUND

• Lakra A, Tram MK, Bernasek TL, Lyons ST, O'Connor CM. Frailty is Associated With Increased Complication, Readmission, and Hospitalization Costs Following Primary Total Knee Arthroplasty. J Arthroplasty. 2023 Jul;38(7 Suppl 2):S182-S186.e2. doi: 10.1016/j.arth.2023.02.036. Epub 2023 Feb 28.

  PMID: 36858131 BACKGROUND

• Gu C, Lu A, Lei C, Wu Q, Zhang X, Wei M, Wang Z. Frailty index is useful for predicting postoperative morbidity in older patients undergoing gastrointestinal surgery: a prospective cohort study. BMC Surg. 2022 Feb 16;22(1):57. doi: 10.1186/s12893-022-01471-9.

  PMID: 35172806 BACKGROUND

• Fluitman KS, Davids M, Olofsson LE, Wijdeveld M, Tremaroli V, Keijser BJF, Visser M, Backhed F, Nieuwdorp M, IJzerman RG. Gut microbial characteristics in poor appetite and undernutrition: a cohort of older adults and microbiota transfer in germ-free mice. J Cachexia Sarcopenia Muscle. 2022 Aug;13(4):2188-2201. doi: 10.1002/jcsm.13002. Epub 2022 Jun 14.

  PMID: 35698917 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Purpose Before the start of this study, we obtained consent from the subjects to collect fecal samples and blood samples and to use these samples for the analysis of intestinal flora and biochemical indices. 2. Sample type and purpose Stool samples: To analyze the composition of the intestinal flora. Blood samples: for the detection of inflammatory factors and oxidative stress. 3. Harmonized storage and destruction Preservation: All samples will be preserved after collection to ensure security and data confidentiality. Destruction Policy: All samples will be securely destroyed at the end of the study to ensure personal data security and compliance with ethical requirements.

MeSH Terms

Conditions

Frailty; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Xianwei Zhang, Doctor

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianwei Zhang, Doctor

CONTACT

13296696810; ourpain@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: March 12, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)