A study investigating a continuous local anaesthetic infusion for pain relief after pelvic tumour surgery

Not Applicable

Completed

• Conditions: Patients undergoing hemi-pelvectomy for pelvic tumours; Cancer

• Registration Number: ISRCTN60374925
• Lead Sponsor: Royal Orthopaedic Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients aged 18 and over
2. Known diagnosis of a pelvic malignancy (primary or secondary)
3. Undergoing a hemipelvectomy
4. Ability to provide informed consent

Exclusion Criteria

1. Do not consent to participation in the trial
2. Pre-existing pain syndromes that may affect perception of pain
3. History of opioid dependence
4. Previous adverse reaction to local anaesthetic
5. Established hepatic or renal insufficiency (CKD Stage 3 or greater)
6. A pre-existing clinical diagnosis of dementia
7. Pregnancy

Withdrawal criteria:
1. Failure to initiate therapy in line with the protocol
2. Unsuccessful insertion of paravertebral block catheter
3. Clinical evidence of wound or catheter infection
4. Adverse reaction to local anaesthetic
5. Respiratory support from invasive ventilation post-operatively

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain score – measured by Numeric Rating Scales (NRS) (0-10)<br>1.1. Worst pain score<br>1.2. Least pain score<br>1.3. Frequency of severe pain (NRS 0-100%)<br>Pain will be measured at 4, 8, 12, 24 hours post-operatively using a validated questionnaire. It will be measured daily between 24 hours - 7 days and then weekly until discharge. A final questionnaire will be administered on the day of discharge.