Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-02-04 @ 5:52 AM
Study NCT ID:
NCT03395912
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2017-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section and Postoperative Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.', 'timeFrame': 'up to 24 hours', 'description': 'Visual analogue scale pain severity with scale from 0 to 10, with score 10 representing the maximum level of pain.'}], 'secondaryOutcomes': [{'measure': 'Length of the cesarean section', 'timeFrame': 'up to 24 hours', 'description': 'Time from first incision to the end of incision closure'}, {'measure': 'Time from surgery to mobility', 'timeFrame': 'up to 48 hours', 'description': 'Time from the end of surgery to mobility'}, {'measure': 'Time from surgery to breastfeeding', 'timeFrame': 'up to 4 days', 'description': 'Time from the end of surgery to breastfeeding'}, {'measure': 'Need for opioids', 'timeFrame': 'up to 4 days', 'description': 'Type and dosage of opioids needed'}, {'measure': 'Surgical site hematoma', 'timeFrame': '4 days', 'description': 'Post operative surgical site hematoma'}, {'measure': 'surgical site infection', 'timeFrame': 'up to 42 days', 'description': 'Post operative surgical site infection'}, {'measure': 'questionnaire', 'timeFrame': 'up to 4 days', 'description': "Post operative women's satisfaction with scale from 0 to 10, with score 10 representing the maximum level of satisfaction."}, {'measure': 'Length of stay from surgery to discharge', 'timeFrame': 'up to 4 days', 'description': 'Length of stay from surgery to discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['local anesthetics infiltration', 'cesarean section pain relief'], 'conditions': ['Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '17880313', 'type': 'BACKGROUND', 'citation': 'Karlstrom A, Engstrom-Olofsson R, Norbergh KG, Sjoling M, Hildingsson I. Postoperative pain after cesarean birth affects breastfeeding and infant care. J Obstet Gynecol Neonatal Nurs. 2007 Sep-Oct;36(5):430-40. doi: 10.1111/j.1552-6909.2007.00160.x.'}, {'pmid': '18818022', 'type': 'BACKGROUND', 'citation': "Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24."}, {'pmid': '28236348', 'type': 'BACKGROUND', 'citation': 'Yefet E, Taha H, Salim R, Hasanein J, Carmeli Y, Schwartz N, Nachum Z. Fixed time interval compared with on-demand oral analgesia protocols for post-caesarean pain: a randomised controlled trial. BJOG. 2017 Jun;124(7):1063-1070. doi: 10.1111/1471-0528.14546. Epub 2017 Feb 25.'}, {'pmid': '27259092', 'type': 'RESULT', 'citation': 'Adesope O, Ituk U, Habib AS. Local anaesthetic wound infiltration for postcaesarean section analgesia: A systematic review and meta-analysis. Eur J Anaesthesiol. 2016 Oct;33(10):731-42. doi: 10.1097/EJA.0000000000000462.'}, {'pmid': '11093995', 'type': 'RESULT', 'citation': 'Fredman B, Shapiro A, Zohar E, Feldman E, Shorer S, Rawal N, Jedeikin R. The analgesic efficacy of patient-controlled ropivacaine instillation after Cesarean delivery. Anesth Analg. 2000 Dec;91(6):1436-40. doi: 10.1097/00000539-200012000-00025.'}, {'pmid': '12066096', 'type': 'RESULT', 'citation': 'Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound irrigation with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol. 2002 Jun;186(6):1188-91. doi: 10.1067/mob.2002.122984.'}, {'pmid': '17525598', 'type': 'RESULT', 'citation': "Lavand'homme PM, Roelants F, Waterloos H, De Kock MF. Postoperative analgesic effects of continuous wound infiltration with diclofenac after elective cesarean delivery. Anesthesiology. 2007 Jun;106(6):1220-5. doi: 10.1097/01.anes.0000267606.17387.1d."}, {'pmid': '8717568', 'type': 'RESULT', 'citation': 'Mecklem DW, Humphrey MD, Hicks RW. Efficacy of bupivacaine delivered by wound catheter for post-Caesarean section analgesia. Aust N Z J Obstet Gynaecol. 1995 Nov;35(4):416-21. doi: 10.1111/j.1479-828x.1995.tb02156.x.'}, {'pmid': '20582749', 'type': 'RESULT', 'citation': 'Tuncer S, Aysolmaz G, Reisli R, Erol A, Yalcin N, Yosunkaya A. [The effects of the administration of subfacial levobupivacaine infusion with the ON-Q pain pump system on postoperative analgesia and tramadol consumption in cesarean operations]. Agri. 2010 Apr;22(2):73-8. Turkish.'}, {'pmid': '16980157', 'type': 'RESULT', 'citation': 'Zohar E, Shapiro A, Eidinov A, Fishman A, Fredman B. Postcesarean analgesia: the efficacy of bupivacaine wound instillation with and without supplemental diclofenac. J Clin Anesth. 2006 Sep;18(6):415-21. doi: 10.1016/j.jclinane.2006.01.001.'}, {'pmid': '26366789', 'type': 'RESULT', 'citation': 'Jolly C, Jathieres F, Keita H, Jaouen E, Guyot B, Torre A. Cesarean analgesia using levobupivacaine continuous wound infiltration: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:125-30. doi: 10.1016/j.ejogrb.2015.08.023. Epub 2015 Aug 25.'}, {'pmid': '23260628', 'type': 'RESULT', 'citation': 'Corsini T, Cuvillon P, Forgeot A, Chapelle C, Seffert P, Chauleur C. [Single-dose intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a placebo-controlled double-blind randomized trial]. Ann Fr Anesth Reanim. 2013 Jan;32(1):25-30. doi: 10.1016/j.annfar.2012.10.035. Epub 2012 Dec 21. French.'}, {'pmid': '22024157', 'type': 'RESULT', 'citation': 'Ducarme G, Sillou S, Wernet A, Davitian C, Poujade O, Ceccaldi PF, Bougeois B, Luton D. [Single-shot ropivacaine wound infiltration during cesarean section for postoperative pain relief]. Gynecol Obstet Fertil. 2012 Jan;40(1):10-3. doi: 10.1016/j.gyobfe.2011.07.035. Epub 2011 Oct 22. French.'}, {'pmid': '18467147', 'type': 'RESULT', 'citation': 'Bensghir M, Elwali A, Miller C, Azendour H, Drissi M, Bakkali H, Belyamani L, Atmani M, Drissi Kamili N. [Effects of skin infiltration with ropivacaine 0,75% on postoperative pain after caesarean section]. Gynecol Obstet Fertil. 2008 May;36(5):516-20. doi: 10.1016/j.gyobfe.2008.03.007. Epub 2008 May 7. French.'}, {'pmid': '15636950', 'type': 'RESULT', 'citation': 'Pavy T, Gambling D, Kliffer P, Munro A, Merrick PM, Douglas J. Effect of preoperative skin infiltration with 0.5% bupivacaine on postoperative pain following cesarean section under spinal anesthesia. Int J Obstet Anesth. 1994 Oct;3(4):199-202. doi: 10.1016/0959-289x(94)90068-x.'}, {'pmid': '21219106', 'type': 'RESULT', 'citation': 'Sekhavat L, Behdad S. Preoperative analgesia with local lidocaine for cesarean delivery pain relief. J Matern Fetal Neonatal Med. 2011 Jul;24(7):891-3. doi: 10.3109/14767058.2010.537410. Epub 2011 Jan 10.'}, {'pmid': '2035794', 'type': 'RESULT', 'citation': 'Trotter TN, Hayes-Gregson P, Robinson S, Cole L, Coley S, Fell D. Wound infiltration of local anaesthetic after lower segment caesarean section. Anaesthesia. 1991 May;46(5):404-7. doi: 10.1111/j.1365-2044.1991.tb09558.x.'}, {'pmid': '28329326', 'type': 'RESULT', 'citation': 'Parascandola SA, Ibanez J, Keir G, Anderson J, Plankey M, Flynn D, Cody C, De Marchi L, Margolis M, Blair Marshall M. Liposomal bupivacaine versus bupivacaine/epinephrine after video-assisted thoracoscopic wedge resectiondagger. Interact Cardiovasc Thorac Surg. 2017 Jun 1;24(6):925-930. doi: 10.1093/icvts/ivx044.'}, {'pmid': '10624296', 'type': 'RESULT', 'citation': 'Metaxotos NG, Asplund O, Hayes M. The efficacy of bupivacaine with adrenaline in reducing pain and bleeding associated with breast reduction: a prospective trial. Br J Plast Surg. 1999 Jun;52(4):290-3. doi: 10.1054/bjps.1998.0129.'}, {'pmid': '26309720', 'type': 'RESULT', 'citation': 'Li X, Zhou M, Shi X, Yang H, Li Y, Li J, Yang M, Yuan H. Local anaesthetic wound infiltration used for caesarean section pain relief: a meta-analysis. Int J Clin Exp Med. 2015 Jun 15;8(6):10213-24. eCollection 2015.'}, {'pmid': '36378307', 'type': 'DERIVED', 'citation': 'Garmi G, Parasol M, Zafran N, Rudin M, Romano S, Salim R. Efficacy of Single Wound Infiltration With Bupivacaine and Adrenaline During Cesarean Delivery for Reduction of Postoperative Pain: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242203. doi: 10.1001/jamanetworkopen.2022.42203.'}]}, 'descriptionModule': {'briefSummary': 'Thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics in cesarean section on post operative pain relief. In the study group before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration. Our hypothesis is that subcutaneous infiltration of the surgical wound by BUPIVACAINE + ADRENALIN at the end of cesarean section will reduce the intensity of post operative pain.', 'detailedDescription': 'Cesarean section is one of the most common procedures in the world. There is an advantage in preventing pain after cesarean section, as opposed to treating pain that has already started. The infiltration of surgical wounds by local anesthetics is accepted as an effective method for preventing pain after various operations. In this study women who are admitted for a cesarean section will be randomly allocated into 2 groups. In the study group after the closure of the fascia above the rectus muscles, and before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cesarean section with regional anesthesia\n* singleton\n* pfannenstiel incision\n\nExclusion Criteria:\n\n* cesarean section with general anesthesia\n* maternal liver or kidney disease\n* allergy to Bupivacaine\n* allergy to Adrenalin\n* intrauterine fetal death\n* major fetal malformations'}, 'identificationModule': {'nctId': 'NCT03395912', 'briefTitle': 'Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section and Postoperative Pain.', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Efficacy of a Single-shot Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section in Reducing Postoperative Pain. A Randomized Prospective Controlled Trial', 'orgStudyIdInfo': {'id': '0151-17-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Infiltration of the subcutaneous layer with local anesthetic and combined with adrenaline.', 'interventionNames': ['Drug: Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Abdominal layers will be closed without Infiltration .'}], 'interventions': [{'name': 'Intervention', 'type': 'DRUG', 'otherNames': ['local anesthetic infiltration'], 'description': 'After closing the fascia above the rectus muscles, and before closing the skin, the subcutaneous layer will be infiltrated on both sides of the incision (top and bottom) by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'HaEmek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Gali Garmi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HaEmek Medical Center, Afula, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}