Clinical trial comparing epidurals to rectus sheath catheters for pain relief following major abdominal surgery

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network, Generic Health Relevance and Cross Cutting Themes; Subtopic: Colorectal Cancer, Upper Gastro-Intestinal Cancer, Generic Health Relevance (all Subtopics); Disease: Colon, Duodenum, Pancreas, Stomach, Surgery, Anaesthetics; Surgery

• Registration Number: ISRCTN81223298
• Lead Sponsor: East Lancashire Hospitals NHS Trust (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25336055

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-16
• Study Completion: 2017-06-01
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. Patients over 18 years of age
2. Planned elective major abdominal surgery including major colorectal resections, upper GI surgery (e.g. pancreaticoduodectomy) and major urological surgery (e.g. radical cystectomy)
3. Planned open midline surgical incision
4. Included in the ERP
5. Willing and able to give consent
6. American Society of Anesthesiologists (ASA) score 13

Exclusion Criteria

1. Contraindication to epidural analgesia (e.g. coagulopathy, local infection, systemic sepsis, severe aortic stenosis)
2. Consent refused for either thoracic epidural analgesia (TEA) or Rectus Sheath Catheters (RSCs)
3. Non-English speaker
4. Ano-rectal excision (e.g. pan-proctocolectomy or AP resection)
5. Planned transverse or oblique incisional approach
6. Allergy to local anaesthetic drugs or opiates
7. Opiate tolerance
8. Pre-existing chronic abdominal pain
9. Extensive existing midline abdominal scarring

Study & Design

• Study Type: Interventional
• Study Design: Not specified