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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05853133
• Other study ID #: ESOGU 5
• Status: Completed
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: February 4, 2024

Study information

• Verified date: February 2024
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 4, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Erector Spinae Plane Block
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.
• Wound Infiltration
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.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Faculty of Medicine	Eskisehir	Odunpazari

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	postoperative pain scores	Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))	24 hours