ProstatectomySPITALIDONCT03618693
Impact of Perioperative Analgesia in Prostatectomy Patients on Early Quality of Recovery (SPITALIDO)
A study testing Spinal anesthesia, TAP Block and Standard in people with Prostatectomy and Pain, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The rationale behind this RCT is to assess within 24 hours after surgery the quality of recovery of prostatectomy patients treated with 3 different analgesia concepts (intraoperative spinal analgesia, transversus abdominis plane block, intravenous lidocaine administration) using the quality of recovery (QoR) 15… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatectomy, Pain
- What is being tested?
- Spinal anesthesia, TAP Block and Standard
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Aug 2018to 13 Dec 2021
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- >18 years old
- eGFR >40ml/min
- Normal liver function
- Prostatectomy (open, robotic assisted)
Who cannot join
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- Patients with regular use of antiemetics, laxatives, opioids or other types of analgesics
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
Show all 12Show fewer
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- Severe psychiatric disorder
- Patients with chronic pain
- Preoperative regular use of non-steroidal anti-inflammatory drugs
- Refusal of regional analgesia (SSS or TAP block)
- Contraindication to regional analgesia (SSS or TAP block)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
Bern, Canton of Bern, 3010
About this study
Official title: The Impact of Perioperative Analgesia in Prostatectomy Patients on Early Quality of Recovery
The rationale behind this RCT is to assess within 24 hours after surgery the quality of recovery of prostatectomy patients treated with 3 different analgesia concepts (intraoperative spinal analgesia, transversus abdominis plane block, intravenous lidocaine administration) using the quality of recovery (QoR) 15 questionnaire.
Read the detailed description
Prostatectomy (open or robotic assisted) is a major urological surgery, which is associated with relevant acute postoperative pain. Perioperative analgesic techniques aiming at optimizing postoperative analgesia have to be investigated. Optimal postoperative pain management is one of the key factors leading to enhanced recovery after surgery. Optimal analgesia should aim for optimized patient comfort, fast functional recovery with the fewest side effects thus encouraging the DREAMS concept (DRinking, EAting, Mobilizing and Sleeping).
The perioperative additional use of a spinal single shot analgesia, or a transversus abdominis plane block to general anaesthesia are validated options to enhance pain therapy compared to systemic analgesia alone. However, if the impact on pain scores has been described previously, the impact on the quality of recovery (QoR) is still unclear. Using the assessment of QoR allows for a much more objective and broader assessment of the quality of the postoperative treatment. Indeed, patient's perioperative experience cannot be only focused on pain scores but should involve items like physical independence, patient support, comfort, emotion. All these items are included in already validated QoR questionnaires like the QoR 15 or QoR 40.
The rationale behind this randomized, parallel group, single centre, interventional, active controlled trial is to assess with the QoR 15questionnaire within 24 hours after surgery the quality of recovery of prostatectomy patients treated with 3 different analgesia concepts.
- Conditions
- Prostatectomy, Pain
- Being tested
- Spinal anesthesia, TAP Block, Standard
- Keywords
- prostatectomy, pain, recovery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
Injection of a single shot of local anesthetic bupivacaine 0.5% combined with 20 mcg fentanyl intrathecally.
TAP BlockDevice
TAP block with a single shot of 20ml ropivacaine 0.375% combined with 75 mcg clonidine bilaterally
StandardOther
Also called Control Intervention
Concomitant systemic administration of lidocaine (as an adjuvant) to the standard general anaesthesia. Lidocaine will administered initially during induction with a bolus of 1.5 mg per kgBW, followed by an infusion of 1.5 mg per kgBW per hour for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| spinal analgesia SSS | Experimental | Patients will receive a spinal analgesia (group SSS) with a single shot of bupivacaine 0.5% combined with fentanyl intrathecally during induction of anaesthesia. The technique used is referred to daily practice.
All patients included in the study will receive the same postoperative multimodal analgesia starting at the end of surgery with the following regimen: 30 mg ketorolac 3* per day for 48 hours intravenously and 1 gr 4* per day metamizol intravenously or per oral, depending of the return of bowel function as baseline analgesia during length of hospitalization.
Additional rescue analgesia will be provided and consisted in boluses of 25 mcg fentanyl intravenously (first 24 hours) and thereafter 5-10 mg oxycodone tablets (per oral administration).
Postoperative rehabilitation according to the investigators enhanced recovery program including early mobilization and drinking (clear drinks). Receives: Procedure: Spinal anesthesia |
| TAP block | Experimental | Patients will receive a TAP block with a single shot of ropivacaine 0.375% combined with clonidine bilaterally. The technique used is referred to daily practice. The blocks will be performed under ultrasound guidance.
All patients included in the study will receive the same postoperative multimodal analgesia starting at the end of surgery with the following regimen: 30 mg ketorolac 3* per day for 48 hours intravenously and 1 gr 4* per day metamizol intravenously or per oral, depending of the return of bowel function as baseline analgesia during length of hospitalization.
Additional rescue analgesia will be provided and consisted in boluses of 25 mcg fentanyl intravenously (first 24 hours) and thereafter 5-10 mg oxycodone tablets (per oral administration).
Postoperative rehabilitation according to the investigators enhanced recovery program including early mobilization and drinking (clear drinks). Receives: Device: TAP Block |
| Standard | Active comparator | Standard care for prostatectomy in the investigators institution consists in the concomitant systemic administration of lidocaine to standard general anaesthesia. Lidocaine will administered initially during induction with a bolus of 1.5 mg per kgBW, followed by an infusion of 1.5 mg per kgBW per hour for 24 hours.
All patients included in the study will receive the same postoperative multimodal analgesia starting at the end of surgery with the following regimen: 30 mg ketorolac 3* per day for 48 hours and 1 gr 4* per day metamizol intravenously or per oral, depending of the return of bowel function as baseline analgesia during length of hospitalization.
Additional rescue analgesia will be provided and consisted in boluses of 25 mcg fentanyl intravenously (first 24 hours) and thereafter 5-10 mg oxycodone tablets.
Postoperative rehabilitation according to the investigators enhanced recovery program including early mobilization and drinking (clear drinks). Receives: Other: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Changes in Quality of Recovery using the validated 15 items quality of recovery (QoR-15) score : QoR is a patient reported outcome short questionnaire that measure the quality of recovery after surgery and anaesthesia. It incorporates 5 dimensions of health (patient support, comfort, emotions, physical independence, pain). This is a shortened validated version of the QoR 40 including 15 items. QoR-15, with a score range from 0 to 150, is easy to perform. Recently a meta-analysis showed that QoR 15 fulfils requirements for outcome measurement instruments.
Measured: From preoperative to postoperative day (POD) 1 i.e. within 24 hours after initiation of intervention
Secondary outcomes (4)
Postoperative Nausea and Vomiting (PONV)
Groups will be assessed for postoperative nausea/vomiting by verbal descriptive scale at 6, 24 and 48 hours respectively.
Verbal descriptive Scale
0 No nausea
- Mild nausea
- Moderate nausea
- Frequent vomiting
- Severe vomiting
Measured: during the first 48 hours postoperatively
Pain Score
Pain will be assessed with the use of pain scores (incisional pain, "deep" visceral pain and pain during coughing/mobilization) according to the validated numeric rating scale (NRS with a range of 0 (no pain) to 10 (maximal pain)).
Measured: within 6 hours postoperatively, on POD 1 and 2
Gastrointestinal Function
Return of gastrointestinal function (first flatus, first defecation, tolerance to food) in days.
Measured: During length of stay, expected to be on average 5 to 7 days
Opioid Consumption
Use/amount of opioids intraoperative and postoperatively (transformed in morphine equivalent per 24 hours)
Measured: Within the first 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start13 Aug 2018
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Randomized, parallel group, single centre, interventional, active controlled trial
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wüthrich, MD, Principal investigator, University Hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618693
- Sponsor's protocol ID
- WUPD01-18
- Acronym
- SPITALIDO
- Status last verified
- Dec 2021
- First submitted
- 3 Jul 2018
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beilstein CM, Huber M, Furrer MA, Loffel LM, Wuethrich PY, Engel D. Impact of analgesic techniques on early quality of recovery after prostatectomy: A 3-arm, randomized trial. Eur J Pain. 2022 Oct;26(9):1990-2002. doi: 10.1002/ejp.2020. Epub 2022 Aug 21.
PubMed 35960649
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Perioperative Analgesia in Prostatectomy Patients on Early Quality of Recovery
- ClinicalTrials.gov ID
- NCT03618693
- Acronym / sponsor ID
- SPITALIDO / WUPD01-18
- Conditions
- Prostatectomy, Pain
- Keywords
- prostatectomy, pain, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 7 Aug 2018 (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.
The rationale behind this RCT is to assess within 24 hours after surgery the quality of recovery of prostatectomy patients treated with 3 different analgesia concepts (intraoperative spinal analgesia, transversus abdominis plane block, intravenous lidocaine administration) using the quality of recovery (QoR) 15 questionnaire.
Detailed description
Prostatectomy (open or robotic assisted) is a major urological surgery, which is associated with relevant acute postoperative pain. Perioperative analgesic techniques aiming at optimizing postoperative analgesia have to be investigated. Optimal postoperative pain management is one of the key factors leading to enhanced recovery after surgery. Optimal analgesia should aim for optimized patient comfort, fast functional recovery with the fewest side effects thus encouraging the DREAMS concept (DRinking, EAting, Mobilizing and Sleeping).
The perioperative additional use of a spinal single shot analgesia, or a transversus abdominis plane block to general anaesthesia are validated options to enhance pain therapy compared to systemic analgesia alone. However, if the impact on pain scores has been described previously, the impact on the quality of recovery (QoR) is still unclear. Using the assessment of QoR allows for a much more objective and broader assessment of the quality of the postoperative treatment. Indeed, patient's perioperative experience cannot be only focused on pain scores but should involve items like physical independence, patient support, comfort, emotion. All these items are included in already validated QoR questionnaires like the QoR 15 or QoR 40.
The rationale behind this randomized, parallel group, single centre, interventional, active controlled trial is to assess with the QoR 15questionnaire within 24 hours after surgery the quality of recovery of prostatectomy patients treated with 3 different analgesia concepts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, parallel group, single centre, interventional, active controlled trial
| Arm | Type | Receives |
|---|---|---|
| spinal analgesia SSS | Experimental | Procedure: Spinal anesthesiaPatients will receive a spinal analgesia (group SSS) with a single shot of bupivacaine 0.5% combined with fentanyl intrathecally during induction of anaesthesia. The technique used is referred to daily practice. All patients included in the study will receive the same postoperative multimodal analgesia starting at the end of surgery with the following regimen: 30 mg ketorolac 3* per day for 48 hours intravenously and 1 gr 4* per day metamizol intravenously or per oral, depending of the return of bowel function as baseline analgesia during length of hospitalization. Additional rescue analgesia will be provided and consisted in boluses of 25 mcg fentanyl intravenously (first 24 hours) and thereafter 5-10 mg oxycodone tablets (per oral administration). Postoperative rehabilitation according to the investigators enhanced recovery program including early mobilization and drinking (clear drinks). |
| TAP block | Experimental | Device: TAP BlockPatients will receive a TAP block with a single shot of ropivacaine 0.375% combined with clonidine bilaterally. The technique used is referred to daily practice. The blocks will be performed under ultrasound guidance. All patients included in the study will receive the same postoperative multimodal analgesia starting at the end of surgery with the following regimen: 30 mg ketorolac 3* per day for 48 hours intravenously and 1 gr 4* per day metamizol intravenously or per oral, depending of the return of bowel function as baseline analgesia during length of hospitalization. Additional rescue analgesia will be provided and consisted in boluses of 25 mcg fentanyl intravenously (first 24 hours) and thereafter 5-10 mg oxycodone tablets (per oral administration). Postoperative rehabilitation according to the investigators enhanced recovery program including early mobilization and drinking (clear drinks). |
| Standard | Active comparator | Other: StandardStandard care for prostatectomy in the investigators institution consists in the concomitant systemic administration of lidocaine to standard general anaesthesia. Lidocaine will administered initially during induction with a bolus of 1.5 mg per kgBW, followed by an infusion of 1.5 mg per kgBW per hour for 24 hours. All patients included in the study will receive the same postoperative multimodal analgesia starting at the end of surgery with the following regimen: 30 mg ketorolac 3* per day for 48 hours and 1 gr 4* per day metamizol intravenously or per oral, depending of the return of bowel function as baseline analgesia during length of hospitalization. Additional rescue analgesia will be provided and consisted in boluses of 25 mcg fentanyl intravenously (first 24 hours) and thereafter 5-10 mg oxycodone tablets. Postoperative rehabilitation according to the investigators enhanced recovery program including early mobilization and drinking (clear drinks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- >18 years old
- eGFR >40ml/min
- Normal liver function
- Prostatectomy (open, robotic assisted)
Key exclusion criteria (12 listed)
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- Patients with regular use of antiemetics, laxatives, opioids or other types of analgesics
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
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 |
|---|---|---|
| Spinal anesthesiaInjection of a single shot of local anesthetic bupivacaine 0.5% combined with 20 mcg fentanyl intrathecally. | Procedure or surgery | spinal analgesia SSS |
| TAP BlockTAP block with a single shot of 20ml ropivacaine 0.375% combined with 75 mcg clonidine bilaterally | Device | TAP block |
| StandardAlso: Control InterventionConcomitant systemic administration of lidocaine (as an adjuvant) to the standard general anaesthesia. Lidocaine will administered initially during induction with a bolus of 1.5 mg per kgBW, followed by an infusion of 1.5 mg per kgBW per hour for 24 hours. | Other | Standard |
Primary outcome
Quality of Recovery
Time frame: From preoperative to postoperative day (POD) 1 i.e. within 24 hours after initiation of intervention
Changes in Quality of Recovery using the validated 15 items quality of recovery (QoR-15) score : QoR is a patient reported outcome short questionnaire that measure the quality of recovery after surgery and anaesthesia. It incorporates 5 dimensions of health (patient support, comfort, emotions, physical independence, pain). This is a shortened validated version of the QoR 40 including 15 items. QoR-15, with a score range from 0 to 150, is easy to perform. Recently a meta-analysis showed that QoR 15 fulfils requirements for outcome measurement instruments.
4 secondary outcomes
Postoperative Nausea and Vomiting (PONV)
Time frame: during the first 48 hours postoperatively
Pain Score
Time frame: within 6 hours postoperatively, on POD 1 and 2
Gastrointestinal Function
Time frame: During length of stay, expected to be on average 5 to 7 days
Opioid Consumption
Time frame: Within the first 48 hours postoperatively
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 14 Dec 2021.
- Derived from this study: PubMed 35960649Beilstein CM, Huber M, Furrer MA, Loffel LM, Wuethrich PY, Engel D. Impact of analgesic techniques on early quality of recovery after prostatectomy: A 3-arm, randomized trial. Eur J Pain. 2022 Oct;26(9):1990-2002. doi: 10.1002/ejp.2020. Epub 2022 Aug 21.
- Individual participant dataSharing planned: No
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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.
Patrick Wüthrich, MD principal investigator
University Hospital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia, TAP Block and Standard in people with Prostatectomy and Pain, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 12 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 14 Dec 2021. 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 Switzerland. 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?
Quality of Recovery (time frame: From preoperative to postoperative day (POD) 1 i.e. within 24 hours after initiation of intervention). 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 NCT03618693, which also lists 1 linked publication.
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 14 Dec 2021.