Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT05853133
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2023-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Postoperative Quality of Recovery Score in Radical Prostatectomy With Erector Spinae Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'In the postoperative period, the effectiveness and safety of the block will be evaluated by another researcher (blind) who does not know which group the patient is in.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Group E: Before the operation, the ESP block will be applied to the patients bilaterally, in the prone position under sedation by same anesthesiologist. Group E (ESP block) will be applied 20 ml of %0.25 bupivacaine between the erector spina muscle and transverse process at the 11th thoracic level.\n\nGroup W: At the end of the operation,wound infiltration will be administered under general anesthesia in supine position by surgeon. Subfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each)\n\nIn the postoperative period, the patient was evaluated to the groups at the 2st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, tramadol consumption, nausea-vomiting score, ramsey sedation scale, postoperative complications will be recorded. A 40-item recovery of quality of score will be applied in the preoperative and postoperative period to evaluate the patient's quality of life."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-11', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-02', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Quality Of Recovery Score in Radical Prostatectomy', 'timeFrame': 'Postoperative 24 hours', 'description': 'QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200. The QoR-40 scores range from 40 to 200 with a 200 representing a better recovery outcome'}], 'secondaryOutcomes': [{'measure': 'Total opiate consumption', 'timeFrame': '24 hours', 'description': 'Total tramadol patient control analgesia prepared 4 mg / ml. PCA 10 mg bolus dose will be delivered with 15 min lock-out time. Follow up tramadol consumption at postoperative 24 hours'}, {'measure': 'postoperative pain scores', 'timeFrame': '24 hours', 'description': 'Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector Spinae Plane Block', 'Wound Infiltration', 'Radical Prostatectomy', 'Postoperative Pain'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '23965191', 'type': 'BACKGROUND', 'citation': 'Elkassabany N, Ahmed M, Malkowicz SB, Heitjan DF, Isserman JA, Ochroch EA. Comparison between the analgesic efficacy of transversus abdominis plane (TAP) block and placebo in open retropubic radical prostatectomy: a prospective, randomized, double-blinded study. J Clin Anesth. 2013 Sep;25(6):459-65. doi: 10.1016/j.jclinane.2013.04.009. Epub 2013 Aug 17.'}, {'pmid': '33838536', 'type': 'BACKGROUND', 'citation': 'Dost B, Kaya C, Ozdemir E, Ustun YB, Koksal E, Bilgin S, Bostanci Y. Ultrasound-guided erector spinae plane block for postoperative analgesia in patients undergoing open radical prostatectomy: A randomized, placebo-controlled trial. J Clin Anesth. 2021 Sep;72:110277. doi: 10.1016/j.jclinane.2021.110277. Epub 2021 Apr 7.'}, {'pmid': '29518667', 'type': 'BACKGROUND', 'citation': 'Tulgar S, Senturk O. Ultrasound guided low thoracic erector spinae plane block for postoperative analgesia in radical retropubic prostatectomy, a new indication. J Clin Anesth. 2018 Jun;47:4. doi: 10.1016/j.jclinane.2018.02.013. Epub 2018 Mar 5. No abstract available.'}, {'pmid': '33221776', 'type': 'BACKGROUND', 'citation': 'Osaheni O, Idehen HO, Imarengiaye CO. Analgesia for postoperative myomectomy pain: A comparison of ultrasound-guided transversus abdominis plane block and wound infiltration. Niger J Clin Pract. 2020 Nov;23(11):1523-1529. doi: 10.4103/njcp.njcp_162_19.'}, {'pmid': '34197976', 'type': 'BACKGROUND', 'citation': 'Lemoine A, Witdouck A, Beloeil H, Bonnet F; PROSPECT Working Group Of The European Society Of Regional Anaesthesia And Pain Therapy (ESRA). PROSPECT guidelines update for evidence-based pain management after prostatectomy for cancer. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100922. doi: 10.1016/j.accpm.2021.100922. Epub 2021 Jun 29.'}, {'pmid': '34340839', 'type': 'BACKGROUND', 'citation': 'Canitez A, Kozanhan B, Aksoy N, Yildiz M, Tutar MS. Effect of erector spinae plane block on the postoperative quality of recovery after laparoscopic cholecystectomy: a prospective double-blind study. Br J Anaesth. 2021 Oct;127(4):629-635. doi: 10.1016/j.bja.2021.06.030. Epub 2021 Jul 31.'}, {'pmid': '10740540', 'type': 'BACKGROUND', 'citation': 'Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.'}]}, 'descriptionModule': {'briefSummary': 'Radical prostatectomy is performed with a median incision below the umbilicus. Although the position is supine, the waist extension movement is created in order to facilitate access to the surgical site. The investigator think that this may be a factor affecting the postoperative comfort, not only in the pain in the surgical field, but especially in patients with low back pain (facet joint pain, etc.). Techniques that provide quality postoperative recovery with reduced morbidity and rapid return to daily activities are important for anesthesiologists.\n\nIn this study, the investigator aimed to evaluate the postoperative recovery quality (Quality of Recovery score (QoR-40)) of patients who underwent open radical prostatectomy and underwent erector spina plan block and wound infiltration for postoperative analgesia.', 'detailedDescription': "Patients will be randomly divided into 2 groups as Group E (ESP block) and Group W (Wound Infiltration). Before the operation, the ESP block will be applied to the patients in the prone position under sedation by same anesthesiologist. Group E (ESP block) will be applied bilaterally, 20 ml of %0.25 bupivacaine between the erector spinae muscle and transverse process at the 11th thoracic level. Fifteen minutes after the block, the patient's dermotamal examination will be evaluated and patients with successful block will be included in the study.At the end of the operation,wound infiltration will be administered under general anesthesia in supine position by surgeon. Subfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each). At the end of the operation, the patients with a Modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. All patients will be equipped with IV tramadol patient-controlled analgesia (PCA) device. The solution will be prepared such that tramadol is 4 mg / ml. PCA 10 mg bolus dose will be delivered with 15 min lock-out time. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 2st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, tramadol consumption, nausea-vomiting score, ramsey sedation scale, postoperative complications will be recorded. A 40-item recovery of quality of score will be applied in the preoperative and postoperative period to evaluate the patient's quality of life."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'radical prostatectomy surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologist physical status I-III\n* Radical prostatectomy\n\nExclusion Criteria:\n\n* Infection in the incision area\n* Coagulation disorder\n* Known allergy history against to the study drugs\n* Lack of adequate cognitive activity in the use of patient-controlled analgesia and VAS'}, 'identificationModule': {'nctId': 'NCT05853133', 'briefTitle': 'Evaluation of Postoperative Quality of Recovery Score in Radical Prostatectomy With Erector Spinae Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Eskisehir Osmangazi University'}, 'officialTitle': 'Evaluation of Postoperative Quality of Recovery Score in Radical Prostatectomy Cases With Erector Spinae Plane Block and Wound Infiltration', 'orgStudyIdInfo': {'id': 'ESOGU 5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group E', 'description': 'ESP block will be applied bilaterally, 20 ml of %0.25 bupivacaine between the erector spinae muscle and transverse process at the 11th thoracic level.', 'interventionNames': ['Other: Erector Spinae Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group W', 'description': 'Subfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each).', 'interventionNames': ['Other: Wound Infiltration']}], 'interventions': [{'name': 'Erector Spinae Plane Block', 'type': 'OTHER', 'otherNames': ['Group E'], 'description': "Group E (ESP block), before the operation, the ESP block will be applied to the patients in the prone position under sedation by same anesthesiologist. ESP block will be applied bilaterally, 20 ml of %0.25 bupivacaine between the erector spinae muscle and transverse process at the 11th thoracic level. All patients will be equipped with an IV tramadol patient-controlled analgesia (PCA) device. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 2st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, tramadol consumption, nausea-vomiting score, ramsey sedation scale, postoperative complications will be recorded. A 40-item recovery of quality of score will be applied in the preoperative and postoperative period to evaluate the patient's quality of life.", 'armGroupLabels': ['Group E']}, {'name': 'Wound Infiltration', 'type': 'OTHER', 'otherNames': ['Group W'], 'description': "Group W, at the end of the operation,wound infiltration will be administered under general anesthesia in supine position by same surgeon. Subfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each). All patients will be equipped with an IV tramadol patient-controlled analgesia (PCA) device. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 2st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, tramadol consumption, nausea-vomiting score, ramsey sedation scale, postoperative complications will be recorded. A 40-item recovery of quality of score will be applied in the preoperative and postoperative period to evaluate the patient's quality of life.", 'armGroupLabels': ['Group W']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26040', 'city': 'Eskişehir', 'state': 'Odunpazarı', 'country': 'Turkey (Türkiye)', 'facility': 'Eskisehir Osmangazi University Faculty of Medicine', 'geoPoint': {'lat': 39.77667, 'lon': 30.52056}}], 'overallOfficials': [{'name': 'Meryem Onay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eskisehir Osmangazi University Faculty Of Medıcıne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eskisehir Osmangazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor-Anesthesiologist', 'investigatorFullName': 'Meryem Onay', 'investigatorAffiliation': 'Eskisehir Osmangazi University'}}}}