Evaluation of Postoperative Quality of Recovery Score in Radical Prostatectomy With Erector Spinae Plane Block

Study Overview
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Brief Summary
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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. In 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.

Detailed Description
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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.

Official Title
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Evaluation of Postoperative Quality of Recovery Score in Radical Prostatectomy Cases With Erector Spinae Plane Block and Wound Infiltration

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: Erector Spinae Plane Block
* Other: Wound Infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist physical status I-III Radical prostatectomy Exclusion Criteria: Infection in the incision area Coagulation disorder Known allergy history against to the study drugs Lack of adequate cognitive activity in the use of patient-controlled analgesia and VAS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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. Group 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) In 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group E<br>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. | Other: Erector Spinae Plane Block<br>* 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.<br>* Other names: Group E;|
| Active Comparator: Group W<br>Subfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each). | Other: Wound Infiltration<br>* 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.<br>* Other names: Group W;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Quality Of Recovery Score in Radical Prostatectomy | 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 | Postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opiate consumption | 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 | 24 hours | 
| postoperative pain scores | Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain)) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector Spinae Plane Block, Wound Infiltration, Radical Prostatectomy, Postoperative Pain