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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Other: Wound Infiltration; Other: Erector Spinae Plane Block

• Registration Number: NCT05853133
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-10
• Study Start: 2023-05-16
• Status Verified: 2024-02
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-04
• Last Update Submitted: 2024-02-11
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group W	Wound Infiltration	Subfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each).
Group E	Erector Spinae Plane Block	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Quality Of Recovery Score in Radical Prostatectomy	Postoperative 24 hours	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

Secondary Outcome Measures

Name	Time	Method
Total opiate consumption	24 hours	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
postoperative pain scores	24 hours	Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))

Trial Locations

Locations (1)

Eskisehir Osmangazi University Faculty of Medicine; 🇹🇷 Eskisehir, Odunpazarı, Turkey