Postoperative PainNCT05853133
Evaluation of Postoperative Quality of Recovery Score in Radical Prostatectomy With Erector Spinae Plane Block
A study testing Erector Spinae Plane Block and Wound Infiltration in people with Postoperative Pain, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block and Wound Infiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2023to 4 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist physical status I-III
- Radical prostatectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Faculty of Medicine
Eskişehir, Odunpazarı, 26040
About this study
Official title: Evaluation of Postoperative Quality of Recovery Score in Radical Prostatectomy Cases With Erector Spinae Plane Block and Wound Infiltration
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane Block, Wound Infiltration
- Keywords
- Erector Spinae Plane Block, Wound Infiltration, Radical Prostatectomy, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
Also called Group E
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 InfiltrationOther
Also called Group W
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Erector Spinae Plane Block |
| Group W | Active comparator | Subfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each). Receives: Other: Wound Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative 24 hours
Secondary outcomes (2)
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
Measured: 24 hours
postoperative pain scores
Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start16 May 2023
- Primary completion1 Feb 2024
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Onay, Eskisehir Osmangazi University
- Investigators
- Meryem Onay, Principal investigator, Eskisehir Osmangazi University Faculty Of Medıcıne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853133
- Sponsor's protocol ID
- ESOGU 5
- Status last verified
- Feb 2024
- First submitted
- 2 May 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23965191Dost 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.
PubMed 33838536Tulgar 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.
PubMed 29518667Osaheni 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.
PubMed 33221776Lemoine 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.
PubMed 34197976Canitez 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.
PubMed 34340839Myles 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.
PubMed 10740540Onay M, Kaya O, Ozen A, Akkemik U, Yelken B, Gulec MS. Evaluation of the postoperative quality of recovery score in radical prostatectomy with erector spinae plane block: a randomized controlled trial. BMC Anesthesiol. 2026 Mar 21;26(1):269. doi: 10.1186/s12871-026-03749-4.
PubMed 41862822
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Quality of Recovery Score in Radical Prostatectomy Cases With Erector Spinae Plane Block and Wound Infiltration
- ClinicalTrials.gov ID
- NCT05853133
- Acronym / sponsor ID
- ESOGU 5
- Conditions
- Postoperative Pain
- Keywords
- Erector Spinae Plane Block, Wound Infiltration, Radical Prostatectomy, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group E | Active comparator | Other: Erector Spinae Plane BlockESP block will be applied bilaterally, 20 ml of %0.25 bupivacaine between the erector spinae muscle and transverse process at the 11th thoracic level. |
| Group W | Active comparator | Other: Wound InfiltrationSubfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist physical status I-III
- Radical prostatectomy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockAlso: Group EGroup 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. | Other | Group E |
| Wound InfiltrationAlso: Group WGroup 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. | Other | Group W |
Primary outcome
Postoperative Quality Of Recovery Score in Radical Prostatectomy
Time frame: 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
2 secondary outcomes
Total opiate consumption
Time frame: 24 hours
postoperative pain scores
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 23965191Elkassabany 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.
- Background: PubMed 33838536Dost 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.
- Background: PubMed 29518667Tulgar 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.
- Background: PubMed 33221776Osaheni 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.
- Background: PubMed 34197976Lemoine 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.
- Background: PubMed 34340839Canitez 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.
- Background: PubMed 10740540Myles 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.
- Derived from this study: PubMed 41862822Onay M, Kaya O, Ozen A, Akkemik U, Yelken B, Gulec MS. Evaluation of the postoperative quality of recovery score in radical prostatectomy with erector spinae plane block: a randomized controlled trial. BMC Anesthesiol. 2026 Mar 21;26(1):269. doi: 10.1186/s12871-026-03749-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem Onay principal investigator
Eskisehir Osmangazi University Faculty Of Medıcıne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Wound Infiltration in people with Postoperative Pain, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality Of Recovery Score in Radical Prostatectomy (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853133, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.