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Association between preoperative traditional Chinese medicine constitution and chronic postsurgical pain after mastectomy with axillary lymph node dissection: a prospective cohort study

Association between preoperative traditional Chinese medicine constitution types assessed using a constitution questionnaire and the risk of chronic postsurgical pain after mastectomy with axillary lymph node dissection: a prospective observational cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107982
Enrollment
Unknown
Registered
2025-08-21
Start date
2025-08-16
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Chronic postsurgical pain (CPSP)

Interventions

Observation group:None

Sponsors

Yancheng First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 40–59 years; 2. Scheduled to undergo elective breast cancer surgery under general anaesthesia, specifically total mastectomy with axillary lymph node dissection or modified radical mastectomy, without prior neoadjuvant chemotherapy or radiotherapy; 3. American Society of Anesthesiologists physical status I–III; 4. No history of chronic pain, including but not limited to chronic neuropathic pain or chronic musculoskeletal pain; 5. Able to complete the traditional Chinese medicine constitution assessment within 24 hours before surgery; 6. No language, hearing, or cognitive impairment that could interfere with questionnaire completion, and able to understand and complete pain assessments and related questionnaires reliably; 7. Willing to provide written informed consent and able to complete the 90-day postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1. Severe psychiatric disorder, currently unstable psychiatric symptoms, cognitive impairment, or any other condition preventing reliable completion of the study questionnaires; 2. Long-term regular use of analgesics, antidepressants, psychotropic medications, or other medications considered likely to substantially interfere with pain assessment; 3. Pregnancy or breastfeeding; 4. Severe cardiac dysfunction, respiratory failure, severe hepatic dysfunction, or renal insufficiency; 5. Anticipated inability to complete the 90-day postoperative follow-up; 6. Refusal to undergo the preoperative assessment or failure to provide written informed consent.

Design outcomes

Primary

MeasureTime frame
clinically relevant CPSP;

Secondary

MeasureTime frame
The total cumulative dose of all opioid and non-opioid analgesics administered within 72 hours postoperatively.;NRS pain scores at rest and during movement;Pain location and patient-reported pain characteristics;

Countries

China

Contacts

Public ContactZhu Jixiang

Yancheng First People's Hospital

guard_mz@163.com+86 515 8850 8812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026