Intra-epidermal Nerve Fibre Density and Its Relationship to Post-caesarean Section Pain

NCT03715075 | Unknown

• 1 other identifier: IENFD in Caesarean Section
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is a significant burden to the individual and society with post-surgical pain identified as a research priority for the speciality of anaesthesia. The objectives are to explore the relationship between IENFD and pain after caesarean section and to explore the characteristics of post-caesarean section pain. The hypothesis is that reduced pre-operative IENFD at the surgical site will correlate with risk of developing CPSP.

Conditions

Chronic Pain; Cesarean Section Complications

Keywords

Intra-epidermal; nerve fibre density

Outcome Measures

Primary Outcomes (1)

• Chronic Pain

  Does the patient have pain at the operation site. A binary measure (yes or no).

  6 months

Secondary Outcomes (2)

• Brief Pain Inventory Score

  6 months

• Short Leeds Assessment of Neuropathic Signs and Symptoms

  6 months

Study Arms (1)

Post-caesarean section group

This single cohort observational study shall recruit women undergoing elective caesarean section within the Simpson's Centre for Reproductive Health (SCRH).

Procedure: Caesarean Section

Interventions

Caesarean Section PROCEDURE

Caesarean Section

Post-caesarean section group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing an elective caesarean section

You may qualify if:

• Women undergoing an elective caesarean section
• Aged 18-65 years

You may not qualify if:

• Women undergoing urgent caesarean section
• Women with little or no English language skills - the questionnaires used are only validated for use in the English language.
• Women with cognitive impairment or mental health disorder that inhibits their ability to provide consent and/or participate in follow-up

Sponsors & Collaborators

• Royal Infirmary of Edinburgh: lead

Study Sites (1)

Oliver Daly

Edinburgh, Midlothian, EH16 4SA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist, NRS Career Research Fellow

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 22, 2018
• Study Start: March 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)