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Are the sympathetic sensorimotor changes induced by thoracic epidural anaesthesia such that mobilization is possible?

Are the sympathetic sensorimotor changes induced by thoracic epidural anaesthesia such that mobilization is possible?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74560140
Enrollment
80
Registered
2006-09-29
Start date
2005-09-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Surgery: Thoracotomy Surgery Thoracotomy

Interventions

A total of 80 patients who have been listed for elective thoracotomy for whom epidural analgesia has been agreed will be invited to participate in the study on the day before their operation. The epid

Sponsors

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All adult patients having elective thoracotomy under general anaesthesia with epidural analgesia for post operative pain relief at the Cardiothoracic Centre, Liverpool. The statistical calculations were done based on a similar study looking at epidural analgesia in labor in an ambulatory patient (Anesth Analg 1993;77:919-24). This paper suggests a failure to ambulate in 10% of the patients in the fentanyl group. A difference of 25% between this and the fentanyl/bupivacaine group would be significant clinically. With an alpha error of 5% and a power of 89% then n=80, which is 40 patients in each group.

Exclusion criteria

Exclusion criteria: 1. Patients unable to mobilize preoperatively due to pre existing neurological, cardiorespiratory or locomotor disease 2. Those with known autonomic nervous system dysfunction, those on beta blockers, those with moderate severe angina (Canadian Cardiovascular Society Class 3 or 4), those with diabetes, those with known allergy to bupivacaine/ fentanyl 3. Routine contraindications to epidural catheter placement will apply

Design outcomes

Primary

MeasureTime frame
Demographic data will be recorded: age, height, weight, hand dominance, ASA classification, preoperative medication, surgical procedure, blood loss and level of surgical incision. Primary outcome: The ability to walk with a thoracic epidural.

Secondary

MeasureTime frame
The effect of thoracic epidural blockade on each of the following measurements-systolic, diastolic, mean blood pressure, heart rate change when moving from the sitting to the upright position, leg motor power, dominant side hand grip strength, proprioception, vibration sense, and co ordination.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026