Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-31 @ 1:40 AM
Study NCT ID:
NCT02264795
Status:
COMPLETED
Last Update Posted:
2016-05-03
First Post:
2014-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2014-10-09', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score (VAS) 24hr movement', 'timeFrame': '24 hours', 'description': 'VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours postcesarean delivery'}], 'secondaryOutcomes': [{'measure': 'Anxiety score before surgery (VAS)', 'timeFrame': '5 minutes', 'description': 'Maternal anxiety score before surgery'}, {'measure': 'Pain score (VAS) 2hr rest', 'timeFrame': '2 hours', 'description': 'VAS score (VAS 0-100 mm) for maternal pain at rest at 2 hours postcesarean'}, {'measure': 'Pain score (VAS) 2hr movement', 'timeFrame': '2 hours', 'description': 'VAS score (VAS 0-100 mm) for maternal pain on movement at 2 hours postcesarean'}, {'measure': 'Pain Score (VAS) 24hr rest', 'timeFrame': '24 hours', 'description': 'VAS score (VAS 0-100 mm) for maternal pain at rest at 24 hours postcesarean'}, {'measure': 'Pain Score (VAS) 48hr rest', 'timeFrame': '48 hours', 'description': 'VAS score (VAS 0-100 mm) for maternal pain at rest at 48 hours postcesarean'}, {'measure': 'Pain Score (VAS) 48hr movement', 'timeFrame': '48 hours', 'description': 'VAS score (VAS 0-100 mm) for maternal pain on movement at 48 hours postcesarean'}, {'measure': 'Patient satisfaction 2hr', 'timeFrame': '2 hours', 'description': 'Patient satisfaction at 2 hours postcesarean'}, {'measure': 'Patient satisfaction 24hr', 'timeFrame': '24 hours', 'description': 'Patient satisfaction at 24 hours postcesarean'}, {'measure': 'Patient satisfaction 48hr', 'timeFrame': '48 hours', 'description': 'Patient satisfaction at 48 hours postcesarean'}, {'measure': 'Opiate consumption PACU', 'timeFrame': '2 hours', 'description': 'Opiate consumption on discharge from PACU'}, {'measure': 'Opiate consumption 24hrs', 'timeFrame': '24 hours', 'description': 'Opiate consumption within 24 hours postcesarean'}, {'measure': 'Opiate consumption 48hrs', 'timeFrame': '48 hours', 'description': 'Opiate consumption within 48 hours postcesarean'}, {'measure': 'Side Effect scores', 'timeFrame': '48 hours', 'description': 'Nausea, vomiting and pruritis scores on discharge from PACU, at 24 hours and 48 hours postcesarean'}, {'measure': 'Bowel function', 'timeFrame': '48 hours', 'description': 'Return of bowel function as assessed by passing flatus'}, {'measure': 'Time to request for first opiate', 'timeFrame': '48 hours', 'description': 'Hours to request for first opiate (if any) postcesarean'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cesarean section', 'Lidocaine'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The instillation of local anesthetic into the peritoneum has been found to be safe and effective in reducing postoperative pain and morphine consumption after abdominal surgery. A review of studies reporting serum levels of local anesthetic after intraperitoneal delivery found no cases of clinical toxicity in any of the trials. The studies in this meta-analysis did not include post-cesarean delivery pain and there is a lack of data to support the use of intraperitoneal local anesthetic after cesarean section.\n\nThe purpose of this study is to assess the efficacy of intraperitoneal lidocaine on postoperative pain scores after cesarean delivery. This study will compare a 20ml solution of lidocaine (400mg) with epinephrine 5mcg/ml versus normal saline (placebo) instilled into the peritoneum at the end of surgery in women undergoing cesarean delivery. The investigators hypothesize that intraperitoneal lidocaine will result in lower pain scores, reduce opioid consumption and opioid related side effects, and higher maternal satisfaction after cesarean delivery.', 'detailedDescription': "Postoperative pain after cesarean delivery can have a significant negative impact on the mother's ability to care for her newborn and lead to complications such as thromboembolism, chronic pain, and depression. Postoperative analgesia for cesarean delivery has undergone remarkable improvement and is currently based on a multimodal approach to improve pain control and reduce the systemic complications of opiates. Despite this some patients still experience moderate to severe pain after cesarean delivery, and further strategies to improve analgesia and postoperative recovery are warranted.\n\nThe use of intraperitoneal local anesthetics to reduce postoperative pain has been studied in a variety of surgical settings, such as hysterectomy, laparoscopic cholecystectomy and minor laparoscopic gynecological procedures. These studies have compared different local anesthetics and the timing of local anesthetic delivery in relation to surgery, for example pre-procedure, at the end of surgery or via continuous catheter infusion. Intraperitoneal lidocaine at the end of surgery was associated with lower postoperative pain scores after total abdominal hysterectomy (200mg lidocaine) and laparoscopic cholecystectomy (400mg lidocaine). There is a large growing body of evidence to support the use of intraperitoneal local anesthetic to reduce postoperative pain. However, there is a lack of data to support its use in postcesarean delivery pain. The investigators found one study reporting a decreased incidence of postoperative pain following intraperitoneal lidocaine instillation at the end of cesarean delivery, in which the parietal peritoneum had been sutured.\n\nThe purpose of this study is to evaluate the efficacy of intraperitoneal lidocaine 400mg instillation at the end of cesarean delivery on maternal pain scores and satisfaction, in the context of a multimodal analgesic regimen inclusive of intrathecal opioids and systemic NSAIDs, acetaminophen and opioids. The investigators hypothesize that intraperitoneal lidocaine will decrease VAS pain scores, reduce opioid consumption and opioid related side effects, and increase maternal satisfaction after cesarean delivery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I or II patients\n* 18-50 years of age\n* Term pregnancy\n* Singleton pregnancy\n* Spinal anesthetic\n* Pfannenstiel incision\n* Patients who have given pre-operative informed written consent\n\nExclusion Criteria:\n\n* Patients who refuse or are unable to give consent\n* ASA \\>2\n* Multiple gestation\n* Chronic pain\n* BMI \\>40\n* Contraindication to acetaminophen or non-steroidal anti-inflammatory drugs'}, 'identificationModule': {'nctId': 'NCT02264795', 'briefTitle': 'Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia?', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia? A Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '14-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intraperitoneal instillation of normal saline.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Intraperitoneal instillation lidocaine 2% (400mg) with epinephrine 5mcg/ml.', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Lidocaine HCl'], 'description': 'Lidocaine 2% with epinephrine 5mcg/ml', 'armGroupLabels': ['Lidocaine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': '0.9% Sodium Chloride Solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Naveed Siddiqui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}