Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-01-01 @ 7:57 PM
Study NCT ID:
NCT04985695
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2021-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015360', 'term': 'Analgesia, Epidural'}, {'id': 'D007813', 'term': 'Laparotomy'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total QoR-15 score', 'timeFrame': 'Postoperative day 2', 'description': 'The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0="none of the time" to 10="all the time"; for negative items the scoring was reversed).'}], 'secondaryOutcomes': [{'measure': 'Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery', 'timeFrame': 'Postoperative days 1, and 3', 'description': 'The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0="none of the time" to 10="all the time"; for negative items the scoring was reversed).'}, {'measure': 'Efficacy of postoperative analgesia', 'timeFrame': 'Day 0 and Postoperative days 1, 2, 3 and 30', 'description': 'The efficacy of postoperative analgesia was compared between the two groups with the visual analog scale (VAS). The VAS intensity rating consisted of a 100-mm line with the end points no pain (0 mm) and worst pain (100 mm). Study participants were asked to evaluated with a mark on the line their current pain intensity. The difference between each postoperative treatment VAS score was compared.'}, {'measure': 'Impact of arterial hypotension', 'timeFrame': 'Postoperative days 1, 2 and 3', 'description': 'The impact of arterial hypotension was compared between the two groups with the arterial pressure value before and after laparotomy'}, {'measure': 'Impact of orthostatic hypotension', 'timeFrame': 'Postoperative days 1, 2 and 3', 'description': 'The impact of orthostatic hypotension was compared between the two groups with the arterial pressure value before and after surgery.'}, {'measure': 'Occurrence of nausea and/or vomiting', 'timeFrame': 'Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days', 'description': 'The effect of analgesic technique on nausea and/or vomiting is calculated on the basis of the number of anti-vomiting prescribed.'}, {'measure': 'Postoperative complications link to analgesic technique', 'timeFrame': 'Postoperative days 1, 2 and 3', 'description': 'Number of postoperative complication in both groups'}, {'measure': 'The length of stay', 'timeFrame': 'at hospital discharge up to 30 days', 'description': 'Comparison of the length of stay between the two groups'}, {'measure': 'Return to normal bowel function', 'timeFrame': 'Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days', 'description': 'Delay in hours to promotes normal digestive activity. The included the times to recovery the first bowel sounds, first anal exhaust and defecation.'}, {'measure': 'The quantity of morphine or equivalent', 'timeFrame': 'Day 0 and Postoperative days 1, 2 and 3', 'description': 'The quantity of morphine or equivalent administered during the 48 first hours in both groups'}, {'measure': 'Urinary catheterization', 'timeFrame': 'at hospital discharge up to 30 days', 'description': 'The time during which the patients are taking recourse to postoperative urinary catheterization'}, {'measure': 'Total distance covered', 'timeFrame': 'Postoperative days 1, 2 and 3', 'description': 'Compare the impact of postoperative analgesia in Walking distance (meter) within days following the operation'}, {'measure': 'Failure to set up a catheter', 'timeFrame': 'Postoperative day 1', 'description': 'Number of Failure to delivery catheter in both techniques'}, {'measure': 'The time until the first raised', 'timeFrame': 'Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days', 'description': 'Delay before the first raised in hours'}, {'measure': 'Impact of premature discontinuation of local anesthetic perfusion', 'timeFrame': 'on day 0', 'description': 'Number of premature discontinuation of local anesthetics'}, {'measure': 'Patient satisfaction and need for further consultation', 'timeFrame': 'at hospital discharge up to 30 days and on postoperative day 30', 'description': 'Satisfaction questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative rehabilitation'], 'conditions': ['Laparotomy']}, 'referencesModule': {'references': [{'pmid': '37221022', 'type': 'DERIVED', 'citation': 'Maury T, Elnar A, Marchionni S, Frisoni R, Goetz C, Becret A. Effect of rectus sheath anaesthesia versus thoracic epidural analgesia on postoperative recovery quality after elective open abdominal surgery in a French regional hospital: the study protocol of a randomised controlled QoR-RECT-CATH trial. BMJ Open. 2023 May 23;13(5):e069736. doi: 10.1136/bmjopen-2022-069736.'}]}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters in the sheath of the rectus abdominis muscles.', 'detailedDescription': 'Implementation of fast-track rehabilitation surgery was essential in patient care, specially in oncological point.\n\nIn this way, uses of the technic of local anesthesia, include epidural analgesia, was essential, but this one is associated with few complications. Emergence of new technic of anesthesia with a comparative analgesia and without side effects should be a better alternative than epidural analgesia. Thus, bilateral rectus sheath block has been reported to be effective in management of postoperative pain.\n\nAfter signing of the informed consent, two postoperative analgesia techniques were investigated in patients undergoing midline laparotomy.\n\nThe main objective of this study is to compare the influence of analgesic technique on the Quality of Recovery-15 score. The study design was a prospective, randomized trial with 2 parallel arms (epidural analgesia vs bilateral rectus sheath block).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy\n* Have given an informed written consent\n* Able to read and understand french language\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA (coagulation disorders, progressive neurological disease, or severe spinal disorder),\n* Epidural analgesia contraindication\n* With impossibility to set up bilateral rectus sheath block\n* Participation in another clinical study\n* Pregnant women\n* Patients deprived of their liberty by a judicial or administrative decision,\n* Patients undergoing psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code'}, 'identificationModule': {'nctId': 'NCT04985695', 'acronym': 'QORRECTCATH', 'briefTitle': 'Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block', 'orgStudyIdInfo': {'id': '2021-01-CHRMT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracic epidural anesthesia', 'description': 'Epidural analgesia during midline laparotomy', 'interventionNames': ['Drug: Epidural analgesia', 'Procedure: Laparotomy']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral rectus sheath block', 'description': 'Bilateral rectus sheath block during midline laparotomy', 'interventionNames': ['Drug: Bilateral rectus sheath block', 'Procedure: Laparotomy']}], 'interventions': [{'name': 'Epidural analgesia', 'type': 'DRUG', 'description': 'All patients received local anesthesia (3-5 ml of 2% Lidocaine). During the preoperative induction of anaesthesia a catheter was inserted 4cm into the epidural space. The catheter will be load during the intervention (0.1 ml/kg/h). In postoperative situation, a patient controlled epidural analgesia was introduced with a debit adapted to the arterial pressure.', 'armGroupLabels': ['Thoracic epidural anesthesia']}, {'name': 'Bilateral rectus sheath block', 'type': 'DRUG', 'description': 'Bilateral rectus sheath block was performed Under general anesthesia and with ultrasound guidance. Rectus sheath block was inserted on each side of the abdomen. All patients received ropivacaine through elastomeric pump', 'armGroupLabels': ['Bilateral rectus sheath block']}, {'name': 'Laparotomy', 'type': 'PROCEDURE', 'description': 'A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy', 'armGroupLabels': ['Bilateral rectus sheath block', 'Thoracic epidural anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'state': 'Moselle', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine BECRET, MD', 'role': 'CONTACT', 'email': 'antoine.becret@chr-metz-thionville.fr', 'phone': '387553069', 'phoneExt': '0033'}], 'facility': 'CHR Metz Thionville Hopital de Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '57126', 'city': 'Thionville', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR, PhD', 'role': 'CONTACT', 'email': 'projet-recherche-clinique@chr-metz-thionville.fr', 'phone': '0033387557766'}, {'name': 'Colombe DUCHEMIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHR Metz-Thionville Hopital Bel Air', 'geoPoint': {'lat': 49.35994, 'lon': 6.16044}}], 'centralContacts': [{'name': 'Arpiné EL NAR, PhD', 'role': 'CONTACT', 'email': 'arpine.el-nar@chr-metz-thionville.fr', 'phone': '0033387557766'}], 'overallOfficials': [{'name': 'Antoine BECRET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville Hopital de Mercy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}