Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT03105193
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2017-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2017-03-23', 'studyFirstSubmitQcDate': '2017-04-02', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': '3 days', 'description': 'Total morphine consumption at day 3'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': '0, 6, 12 hours and Postoperative day (POD) 1, 2, 3, 4 and 7', 'description': 'Pain scores using the visual analogue score (VAS)'}, {'measure': 'Systemic Inflammatory Response (CRP and WBC)', 'timeFrame': 'very morning post op starting day 1 until day 4 post op', 'description': 'Blood test'}, {'measure': 'Systemic Local Anesthetic Level', 'timeFrame': 'every morning post op starting day 1 until day 4 post op', 'description': 'Blood test'}, {'measure': 'Length of stay', 'timeFrame': 'Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks', 'description': 'The day that the patient is discharged will be recorded'}, {'measure': 'Return of bowel function', 'timeFrame': 'Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks', 'description': 'Time to flatus, first bowel motion'}, {'measure': 'Readmissions complications', 'timeFrame': '30 days post op', 'description': 'Readmissions complications will be recorded up to day 30 post op using the Clavien-Dindo Classification'}, {'measure': 'Surgical recovery scores (SRS)', 'timeFrame': 'Up to 60 days post op', 'description': 'SRS questionnaires will be administered at day 1 till discharge then POD 14, 30 and 60'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colon surgery', 'Lignocaine', 'Lidocaine', 'Analgesia', 'Local anaesthetic'], 'conditions': ['Laparoscopic Colon Resection', 'Perioperative Analgesia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the analgesic effects of intraperitoneal lignocaine (IPL) compared with intravenous lignocaine (IVL) after laparoscopic colon resections. We plan to run a 2 group randomized, double blind, clinical trial which will look into morphine consumption as the primary outcome.\n\nGroup 1 (IV lignocaine)- IV bolus of lignocaine and a 3 day post operative IV lignocaine infusion. Intra peritoneal (IP) bolus of normal saline + 3 day post operative IP normal saline infusion\n\nGroup 2 (IP lignocaine)- IV bolus of normal saline and a 3 day post operative IV normal saline infusion. IP bolus of lignocaine + 3 day post operative IP lignocaine infusion', 'detailedDescription': 'Over the last 20 years, laparoscopic colonic surgery has become an accepted first-line treatment for colon cancer. A population-based study showed that laparoscopic colonic resections can be performed with lower hospital costs up to 90 days after discharge when compared to open surgery. Laparoscopic colonic resections have also been associated with fewer postoperative complications and lower mortality.\n\nNew Zealand has one of the highest rates of bowel cancer in the world, and it is the second highest cause of cancer deaths in New Zealand. With the implementation of a bowel screening programme in New Zealand, the projected numbers of stage 1 bowel cancers are expected to increase. More avenues to improve perioperative care need to be explored to improve patient outcomes.\n\nControlling postoperative pain effectively has been shown to reduce the length of hospital stay and improve patient/clinical outcomes. Opioids work as μ-receptor agonists in the spinal cord and brain, and although opioids are excellent at reducing pain, they are associated with nausea, vomiting, dizziness, decreased blood pressure, and urinary retention. Epidurals have been incorporated into Enhanced Recovery After Surgery protocols for controlling post-operative pain. However, epidurals are an invasive procedure with significant side effects such as hypotension, urinary retention, respiratory depression, motor blockade and rarely epidural abscess and meningitis. It has also been shown that up to 30 percent of epidural catheters dislodge, block or leak. These complications have led to a movement towards other regional analgesia techniques which allow local anaesthetic (LA) to target the abdominal wound specifically.\n\nIntraperitoneal local anaesthetic (IPLA) has shown promise in reducing pain after colonic surgery with a meta-analysis9, and a recent IPLA colorectal study conducted at Counties Manukau health showing that it reduces pain and opioid use over and above the effect of an epidural10, which is primarily aimed at the abdominal wound. After an IPLA bolus serum local anaesthetic levels are detectable within 2 minutes. Some studies show reduced early postoperative pain and opioid consumption with intravenous lignocaine infusion alone. The question remains however if there is a benefit from using intraperitoneal local anaesthetic compared to administering it intravenously as the IPLA should block both the intraabdominal wound, via a local action, and the skin wound via a systemic action.. This has been investigated in four studies, however none of these studies compared intravenous local anaesthetic (IVLA) and IPLA for colon resection.\n\nThe aim is that, by optimising analgesia regimes using local anaesthetic, we can improve patient experience of pain and recovery thereby achieving an earlier discharge and early recovery from surgery. This has significant economic benefits for all involved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consecutive consenting patients undergoing elective laparoscopic colonic resections will be recruited from surgical outpatient clinics at Manukau Super Clinic.\n\nExclusion Criteria:\n\n* under 16 years of age\n* acute colonic resection\n* those with ASA \\>= 4\n* previous adverse reaction/allergy to local anaesthetic,\n* surgery for rectal lesions which was defined as lesion within 15 cm of the anal verge\n* preoperative systemic steroid dependence\n* hepatic dysfunction, opioid use greater than 6 months\n* a diagnosis of Chronic Pain Syndrome\n* inability to consent or complete data scores in the study questionnaires due to cognitive impairment and/or language barrier.'}, 'identificationModule': {'nctId': 'NCT03105193', 'briefTitle': 'Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections', 'organization': {'class': 'OTHER', 'fullName': 'University of Auckland, New Zealand'}, 'officialTitle': 'Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections', 'orgStudyIdInfo': {'id': 'IPL/IVL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraperitoneal Lignocaine', 'description': 'IP Lignocaine', 'interventionNames': ['Drug: IV Saline bolus and infusion', 'Drug: IP Lignocaine bolus and infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous lignocaine', 'description': 'IV lignocaine', 'interventionNames': ['Drug: IP Saline bolus and infusion', 'Drug: IV lignocaine bolus and infusion']}], 'interventions': [{'name': 'IV Saline bolus and infusion', 'type': 'DRUG', 'description': 'Intravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump', 'armGroupLabels': ['Intraperitoneal Lignocaine']}, {'name': 'IP Saline bolus and infusion', 'type': 'DRUG', 'otherNames': ['Lidocaine'], 'description': 'Intraperitoneal bolus of normal saline down first port site. 3 day post operative intraperitoneal infusion of normal saline via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump.', 'armGroupLabels': ['Intravenous lignocaine']}, {'name': 'IV lignocaine bolus and infusion', 'type': 'DRUG', 'otherNames': ['Lidocaine'], 'description': 'Intravenous lignocaine bolus at induction. 3 day postoperative IV infusion of lignocaine administered by ambit pump', 'armGroupLabels': ['Intravenous lignocaine']}, {'name': 'IP Lignocaine bolus and infusion', 'type': 'DRUG', 'description': 'Intraperitoneal bolus of lignocaine down first port site. 3 day post operative intraperitoneal infusion of lignocaine via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump.', 'armGroupLabels': ['Intraperitoneal Lignocaine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Manukau Surgical Centre, Middlemore Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Andrew G Hill', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Auckland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Auckland, New Zealand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS', 'investigatorAffiliation': 'University of Auckland, New Zealand'}}}}