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

NCT05853133 | Completed

• 1 other identifier: ESOGU 5
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Erector Spinae Plane Block; Wound Infiltration; Radical Prostatectomy; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total opiate consumption

  24 hours

• postoperative pain scores

  24 hours

Study Arms (2)

Group E

ACTIVE COMPARATOR

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

Group W

ACTIVE COMPARATOR

Subfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each).

Other: Wound Infiltration

Interventions

Erector Spinae Plane Block OTHER

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.

Also known as: Group E

Group E

Wound Infiltration OTHER

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.

Also known as: Group W

Group W

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: radical prostatectomy surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist physical status I-III
• Radical prostatectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Location

Related Publications (7)

• 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: 23965191 BACKGROUND

• 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: 33838536 BACKGROUND

• 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: 29518667 BACKGROUND

• 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: 33221776 BACKGROUND

• 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: 34197976 BACKGROUND

• 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: 34340839 BACKGROUND

• 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.

  PMID: 10740540 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Meryem Onay

  Eskisehir Osmangazi University Faculty Of Medıcıne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Anesthesiologist

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: May 16, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 4, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

TU (1)