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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
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The investigators plan to compare epidurals versus wound catheters for effects on pain relief and recovery following open liver surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound catheter | Experimental | Wound catheter |
|
| Epidural | Active Comparator | Standard epidural, pre-operative insertion, to be run for 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound catheter | Device | Wound catheter, placed at end of procedure, prior to closure. To be kept in for 48 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Number of days (to nearest half day) patients stay in hospital. | Measurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Visual analogue scores of pain experienced. | Performed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery. |
| Molecular response to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (EQ-5D) | Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative | |
| Morphine consumption | Day of surgery and postoperative days 1-7 | |
| IV Fluid volume |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Hughes, MBChB | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | Lothian | EH16 4SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22882198 | Background | Revie EJ, McKeown DW, Wilson JA, Garden OJ, Wigmore SJ. Randomized clinical trial of local infiltration plus patient-controlled opiate analgesia vs. epidural analgesia following liver resection surgery. HPB (Oxford). 2012 Sep;14(9):611-8. doi: 10.1111/j.1477-2574.2012.00490.x. Epub 2012 Jun 10. | |
| 26447461 | Derived |
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| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| Epidural | Device |
|
HMGB1, RAGE and cytokines
| Days 0, 1 and 3 |
| Central Venous Pressure | Mean Central Venous Pressure during liver transection will be quantified and compared between groups. | During liver transection |
| Estimated Blood Loss | Intra-operative |
| Operative field asessment | During liver transection |
| Pringle time | Intra-operative |
| Day of Surgery and postoperative days 1-7 |
| Complications | day of surgery and post-operative days 1-30 |
| Post-operative blood tests (FBC, U&E, LFTs, coag) | Post-operative days 1-7 |
| Hughes MJ, Harrison EM, Peel NJ, Stutchfield B, McNally S, Beattie C, Wigmore SJ. Randomized clinical trial of perioperative nerve block and continuous local anaesthetic infiltration via wound catheter versus epidural analgesia in open liver resection (LIVER 2 trial). Br J Surg. 2015 Dec;102(13):1619-28. doi: 10.1002/bjs.9949. Epub 2015 Oct 8. |
| D013812 |
| Therapeutics |