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

A randomised controlled trial of thoracic epidural analgesia versus rectus sheath catheters for open midline incisions in major abdominal surgery within an Enhanced Recovery Program

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81223298
Enrollment
132
Registered
2014-01-16
Start date
2014-02-02
Completion date
Unknown
Last updated
2018-10-22

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

Conditions

Topic: National Cancer Research Network, Generic Health Relevance and Cross Cutting Themes

Interventions

Potentially eligible patients will be identified by their treating surgical team. If willing to discuss the trial further, their details will be passed on to researchers and written and verbal explan

Sponsors

East Lancashire Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. VAS pain scores at rest and movement (from supine to sitting position) at 2, 6, 12, 24, 48 and 72 hours after wound closure 2. Patient experience

Secondary

MeasureTime frame
1. Functional pain scores and opiate consumption 2. Recovery profile i.e. time to return of GIT function, time until surgically fit for hospital discharge and actual LOS 3. Morbidity including fluid balance, incidence of hypotension and Day 5 POMS score 4. Cost effectiveness and postoperative recovery scores

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026