Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT02210260
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2014-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Relief After Colorectal Surgery: Spinal Combined With Painbuster® vs Painbuster® Alone.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003932', 'term': 'Heroin'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2014-07-31', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuroendocrine response to surgery', 'timeFrame': '24 hours', 'description': 'Peripheral blood samples taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively will be analysed for cortisol and noradrenaline.'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay or fitness for discharge', 'timeFrame': 'Up to 12 days', 'description': 'Discharge criteria:\n\n1. Good pain control with oral analgesia.\n2. Tolerating solid food without nausea and vomiting.\n3. No IV fluid or medication.\n4. Independently mobile and self-caring or at the same level as prior to admission.\n5. Stable observations and blood biochemistry.\n6. No other concerns or complications preventing discharge.'}, {'measure': 'Postoperative complications', 'timeFrame': 'Up to 12 days', 'description': 'All complications in the postoperative period will be recorded. Particular emphasis will be given to:\n\nWound infection\n\nCardiac failure:\n\nComplications related to spinal anaesthesia.\n\nAdequacy of deep vein thrombosis prophylaxis.'}, {'measure': 'Episodes of hypotension in the postoperative period', 'timeFrame': 'Up to 12 days', 'description': 'This will be defined as a sustained systolic blood pressure of less than 90 mm/Hg.'}, {'measure': 'Postoperative pain', 'timeFrame': 'Up to 72 hours after surgery', 'description': 'This will be assessed using a visual analogue scale . Measurements will be taken in recovery then once a day for 72 hours postoperatively. Pain scores will be measured at rest and on coughing.'}, {'measure': 'Postoperative analgesic requirement', 'timeFrame': 'Up to 72 hours after surgery', 'description': 'The total quantity and type (opiate or non-opiate) of all analgesics administered for 72 hours postoperatively.'}, {'measure': 'Amount of postoperative IV fluid administered', 'timeFrame': 'Up to 12 days', 'description': 'Total amount of IV fluid given in postoperative period'}, {'measure': 'Postoperative mobility', 'timeFrame': 'Up to 12 days', 'description': 'Postoperative mobility will be assessed as\n\ntime until able to stand aided and unaided,\n\nduration of time spent out of bed on each postoperative day\n\nmaximum walking distance with assistance on a daily basis.'}, {'measure': 'Return of gut function', 'timeFrame': 'Up to 12 days', 'description': '4.2.8 Time to return of gut function This is defined by the oral/enteral tolerance of \\> 80% of nutritional requirement.\n\nThese requirements will be assessed individually for each patient in the study by an appropriately trained dietician'}, {'measure': 'Oxidative stress', 'timeFrame': 'For 24 hours', 'description': 'Peripheral blood samples will be taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively and analysed for heat shock proteins 37 and 32.'}, {'measure': 'Inflammatory pathway', 'timeFrame': 'Up to 24 hours after surgery', 'description': 'Peripheral blood samples taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively will be analysed for IL1.\n\nPeritoneal biopsies taken prior to closure of surgical wound and analysed for IL1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Colorectal', 'Pain relief'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Limiting surgical stress and managing postoperative pain are well understood to influence recovery and outcome from major surgery for colorectal cancer and both are fundamental aspects of enhanced recovery protocols.\n\nTraditional approaches for dealing with these problems such as epidural or patient controlled intravenous opioid analgesia are associated with problems that may be detrimental to postoperative recovery and surgical outcome. As a result there is evidence in the literature of increasing interest in alternative techniques such as intrathecal anaesthesia or continuous wound infusion of local anaesthetic, however nobody has examined the effect of combining the techniques or their impact on the surgical stress response.\n\nWe intend to compare patients undergoing major resections for colorectal cancer receiving intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those receiving a continuous wound infusion alone. We will examine the surgical stress response and postoperative pain control in addition to objective measures of postoperative recovery.\n\nWe suggest that our approach will attenuate the surgical stress response and provide optimal pain control that will ultimately translate in improved recovery and outcome following surgery for colorectal cancer.', 'detailedDescription': "This is a pilot randomised controlled trial\n\nHypotheses -\n\nFollowing colorectal surgery, spinal anaesthesia combined with a continuous infusion of local anaesthetic into the surgical wound provides\n\n1. better pain relief\n2. a reduced stress response\n\nwhen compared to the use of continuous infusion of local anaesthetic into the surgical wound alone.\n\nPatients undergoing surgical resection for colorectal cancer will be randomised to receive either\n\n1. A single shot of spinal anaesthesia plus a continuous infusion of local anaesthetic into the surgical wound or\n2. Continuous infusion of local anaesthetic into the surgical wound\n\nSpinal Anaesthesia\n\nThe spinal anaesthetic (SA) with be placed after commencement of general anaesthesia this will ensure the patients remain blinded to the intervention. SA will be performed in the lateral position using a midline approach. L3/4 interspace will be identified using Tuffier's as the anatomical landmark. After confirmation of correct placement using a 25G Whitacre needle, 12.5 mg of hyperbaric Bupivacaine in a mixture with 500mcg Diamorphine will be injected intrathecally.\n\nInfusion of local anaesthetic\n\nThe catheter through which the infusion of local anaesthetic will be given, will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine\n\nGeneral anaesthesia will be managed in the same way for both groups"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who are undergoing either laparoscopic or open colorectal resections will be considered eligible for the study.\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Pregnant females.\n* Patients undergoing an abdominoperineal resection.\n* Patients who will not contemplate being randomized to receive a spinal anaesthetic.\n* Patients with a history of failure to place an epidural / spinal anaesthetic.\n* Hypersensitivity to local anaesthetics.\n* Lack of capacity to give consent.'}, 'identificationModule': {'nctId': 'NCT02210260', 'acronym': 'PROSP', 'briefTitle': 'Pain Relief After Colorectal Surgery: Spinal Combined With Painbuster® vs Painbuster® Alone.', 'organization': {'class': 'OTHER', 'fullName': 'York Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Pain Relief After Colorectal Surgery: Single-shot Spinal Combined With Painbuster® vs Painbuster® Alone. A Pilot Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'SNE 2190'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous infusion of local anaesthetic', 'description': 'Continuous infusion of local anaesthetic into the surgical wound', 'interventionNames': ['Procedure: Continuous infusion of local anaesthetic', 'Drug: Bupivacaine', 'Device: A Painbuster® catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Spinal and infusion of local anaesthetic', 'description': 'A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound', 'interventionNames': ['Procedure: Spinal and infusion of local anaesthetic', 'Drug: Bupivacaine', 'Drug: Diamorphine', 'Device: A Painbuster® catheter', 'Device: 25G Whitacre needle']}], 'interventions': [{'name': 'Spinal and infusion of local anaesthetic', 'type': 'PROCEDURE', 'description': "Spinal anaesthetic will be performed in the lateral position using a midline approach. L3/4 interspace will be identified using Tuffier's as the anatomical landmark. After confirmation of correct placement using a 25G Whitacre needle, 12.5 mg of hyperbaric Bupivacaine in a mixture with 500mcg Diamorphine will be injected intrathecally.\n\nPLUS\n\nPainbuster® catheters will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine.", 'armGroupLabels': ['Spinal and infusion of local anaesthetic']}, {'name': 'Continuous infusion of local anaesthetic', 'type': 'PROCEDURE', 'description': 'A Painbuster® catheter will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine.', 'armGroupLabels': ['Continuous infusion of local anaesthetic']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'armGroupLabels': ['Continuous infusion of local anaesthetic', 'Spinal and infusion of local anaesthetic']}, {'name': 'Diamorphine', 'type': 'DRUG', 'description': '500mcg', 'armGroupLabels': ['Spinal and infusion of local anaesthetic']}, {'name': 'A Painbuster® catheter', 'type': 'DEVICE', 'armGroupLabels': ['Continuous infusion of local anaesthetic', 'Spinal and infusion of local anaesthetic']}, {'name': '25G Whitacre needle', 'type': 'DEVICE', 'armGroupLabels': ['Spinal and infusion of local anaesthetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'YO12 6QL', 'city': 'Scarborough', 'state': 'North Yorkshire', 'country': 'United Kingdom', 'facility': 'Scarborough General Hospital', 'geoPoint': {'lat': 54.27966, 'lon': -0.40443}}], 'overallOfficials': [{'name': 'Daniel Harper, MBChB, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'York Teaching Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'York Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}