Radical ProstatectomyPhase 3RAPIDNCT03639389
Postoperative Pain, Recovery and Discharge Following Robot-assisted Laparoscopic Prostatectomy
A Phase 3 study testing Bupivacaine and Analgesics in people with Radical Prostatectomy and Postoperative Pain, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
Prostate cancer is the commonest cancer form in men in Northern Europe. Management of the cancer often includes surgical removal of the primary tumor. In the last 5-10 years, robot assisted laparoscopic prostatectomy (RALP) has become common. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Radical Prostatectomy, Postoperative Pain
- What is being tested?
- Bupivacaine and Analgesics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jan 2019to 29 Mar 2022
- Phase
- Phase 3
- 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 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- Elective robot-assisted laparoscopic prostatectomy Karolinska Hospital
Who cannot join
- Communication limitations (language, mental)
- Chronic opiate use
- Allergy to NSAID
- Coagulation problems preventing administration of spinal analgesia
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Hospital, Solna
Stockholm, 17176
Capio St Görans Hospital
Stockholm
About this study
Official title: Randomised Comparison Between Spinal/GA or GA Alone Following Robot-assisted Laparoscopic Prostatectomy. Stress Response, Pain, Recovery and Home Discharge
Prostate cancer is the commonest cancer form in men in Northern Europe. Management of the cancer often includes surgical removal of the primary tumor. In the last 5-10 years, robot assisted laparoscopic prostatectomy (RALP) has become common. Good pain relief is central to early mobilization and greater patient satisfaction. Randomized controlled studies on pain relief following RALP are few and the role of spinal analgesia in pain management following robotic surgery has not been described. Techniques available for pain relief following RALP include spinal anesthesia with or without opiates, intravenous analgesia with morphine or a multimodal pain management technique using a combination of several analgesics. Spinal anesthesia and analgesia reduces the surgical stress and inflammatory response following laparoscopic colorectal surgery and may offer similar benefit even during RALP.
Early perioperative complications may cause postoperative morbidity following robotic surgery, and sometimes delay home discharge. Since all robotic operations in the pelvic region are performed in a deep Trendelenberg position, this can even have negative consequences for the heart, brain and the lungs. Cardiac complications in the form of minimal cardiac injury or mild heart failure have not been previously studied following RALP. Additionally, patients are sometimes delirious in the early postoperative period following RALP. The precise cause for this remains unclear and may be related to pain, cognitive dysfunction or an urge to pass urine despite a urinary catheter.
Read more
In addition to good postoperative pain relief, early postoperative mobilization and home discharge are important milestones in recovery of full function following major surgery. With improvement in surgical technique, the time has come to evaluate if RALP can be performed on an ambulatory basis. The main aims of this study are:
- Can RALP be performed on an ambulatory basis and patients ready to be discharged home at 8 pm?
- To determine if spinal anesthesia reduces pre-discharge pain intensity, stress response and other perioperative side effects.
- Is sufentanil or fentanyl the analgesic of choice when administered spinally together with bupivacaine as an analgesic.
- To determine the frequency and severity of cardiac and respiratory complications in the steep Trendelenberg position during RALP.
- To assess the quality of recovery, quality of life and activities of daily living following ambulatory RALP?
Read the detailed description
Prospective, randomized study blinded to observers (spinal or no-spinal). All formal approvals will be obtained from different authorities prior to study start. It will be registered in an international database (clinicaltrials.gov).
Patients > 18 years, ASA I-III, undergoing RALP will be included into the study. Patients on chronic opiate medication, those with contraindications to spinal anesthesia or allergy to any component drugs used during spinal anesthesia or other analgesics used in the study will be excluded. Patients living alone or having no adult at home to look after them during the first 24 h after home discharge will also be excluded. Informed written consent will be obtained from all patients. On the morning of surgery, all patients will receive paracetamol 1 g orally 1 h before planned surgery, and will be randomized to one of two groups as shown below:
Robot-assisted laparoscopic prostatectomy (RALP) (morning surgery)
- Group MM: This group of patients will not receive spinal anesthesia but have multimodal pain management including COX-2 blockers, pregabalin and oxycontin for pain management
- Group SF (Spinal/Fentanyl): Spinal anesthesia with bupivacaine 12.5 mg+fentanyl 15 ug Robot-assisted laparoscopic prostatectomy (RALP) (afternoon surgery)
- Group MM: This group of patients will not receive spinal anesthesia but have multimodal pain management including COX-2 blockers, pregabalin and oxycontin for pain management 2. Group SS (Spinal/Sufentanil): Spinal anesthesia with bupivacaine 12.5 mg+sufentanil 5 ug
Anesthesia will be standardized in all other aspects in all groups and basically include propofol for induction, rocuronium as muscle relaxant, sevoflurane and remifentanil for pain management and betamethasone + ondansetron as prophylaxis against post-operative nausea or vomiting (PONV). Surgery will also be standardized in all patients and follow the routines already established in the hospital.
At the end of surgery, patients will be transferred to the post-anesthesia care unit (PACU) where they will remain for 4 h observation and subsequently transferred to the general surgical wards for observation and discharge home. All measurement times will be taken from the end of surgery, which will be considered as t = 0.
The following parameters will be recorded:
- Total morphine consumption during 0-4, 4-home discharge and analgesic supplements after home discharge and up to 1 week will be recorded. Time to first morphine administration after surgery will be registered.
- Blood tests for measurement of cortisol, glucose, insulin, creatinine, NTproBNP and hsTnT will be taken at fixed time points before and after surgery.
- Pain intensity will be registered using NRS after 1, 2, 3, 4 and every 4 h until home discharge, and thereafter every 24 h for 1 week.
- All side effects (PONV, pruritus, respiratory depression, oxygen saturation and need for supplementary oxygen) and complications (bleeding, reoperation, pneumothorax etc.) will be recorded. Postoperative delirium will be assessed 0-2 h postoperatively. Prolonged PACU stay or re-admission to PACU will be registered. Clavien-Dindo classification for grade of complication will be registered as also Postoperative Morbidity score (POMS).
- Respiratory function will be recorded in the following ways: blood gas (after 1 and 4 h), saturation, spirometry, maximum expiratory pressure preoperatively and after 4 h. Need for supplementary oxygen to maintain SpO2 > 93% will be registered.
- Time to mobilization, time to discharge to the general ward (from PACU), "home readiness" (primary endpoint) and home discharge will be registered in accordance with standardized criteria. Criteria for home readiness: normal vital signs, pain intensity < 4 (NRS 0-10), minimal or no postoperative nausea or vomiting, able to sit, walk and go unhindered, no surgical complication (bleeding, fever), fully awake and able to follow instructions (normal cognition), normally functioning urinary catheter and an adult at home during the first 24 h after discharge home).
- Quality of Recovery 15 (QoR 24) will be measured before home-discharge and after 24 h using a standardized questionnaire.
- Quality of life will be measured preoperatively and after 7 and 30 days using the questionnaire EQ5D and WHODAS.
- Conditions
- Radical Prostatectomy, Postoperative Pain
- Being tested
- Bupivacaine, Analgesics
- Keywords
- Robot assisted surgery, Prostatectomy, Spinal anesthesia, Postoperative pain, Home discharge
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcain spinal
Spinal anesthesia with a combination of bupivacaine and fentanyl or sufentanil
AnalgesicsDrug
Also called paracetamol + NSAID + morphine
Combination of paracetamol + non-steroidal anti-inflammatory drug + morphine to all patients
| Study group | Role | What they receive |
|---|---|---|
| Analgesics, multimodal | Active comparator | Combination of paracetamol, non-steroidal anti-inflammatory drug and morphine as analgesics Receives: Drug: Analgesics |
| Bupivacaine | Experimental | Spinal anesthetic with bupivacain + fentanyl/sufentanil Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients ready for home discharge at 8 pm after surgery
Number of patients ready to be discharged home after surgery when using a standardized home-discharge criteria
Measured: With 12 h of surgery start
Secondary outcomes (5)
Pain intensity
Intensity of pain recorded using numeric rating score at defined time intervals postoperatively
Measured: 7 days postoperatively
Stress markers in plasma
Blood glucose, cortisol and insulin
Measured: 24 hours
Quality of Recovery
Quality of recovery will be measured at defined time intervals using a standardized questionnaire
Measured: 3 days postoperatively
Quality of life after surgery
Quality of life will be measured at defined time intervals pre- and postoperatively using a standardized questionnaire
Measured: 30 days postoperatively
Amount (mg) of morphine administered as rescue analgesic at 12 and at 24 h
Total amount of rescue analgesics (morphine) administered to achieve good analgesia and mild pain (NRS < 4)
Measured: At 12 hours and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Jan 2019
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, observer-blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Gupta, Karolinska Institutet
- Investigators
- Håkan Björne, MD, PhD, Study director, Karolinska Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639389
- Sponsor's protocol ID
- 2018-06
- Acronym
- RAPID
- Status last verified
- Jun 2022
- First submitted
- 6 Aug 2018
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not known currently
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Comparison Between Spinal/GA or GA Alone Following Robot-assisted Laparoscopic Prostatectomy. Stress Response, Pain, Recovery and Home Discharge
- ClinicalTrials.gov ID
- NCT03639389
- Acronym / sponsor ID
- RAPID / 2018-06
- Conditions
- Radical Prostatectomy, Postoperative Pain
- Keywords
- Robot assisted surgery, Prostatectomy, Spinal anesthesia, Postoperative pain, Home discharge
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 21 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.
Prostate cancer is the commonest cancer form in men in Northern Europe. Management of the cancer often includes surgical removal of the primary tumor. In the last 5-10 years, robot assisted laparoscopic prostatectomy (RALP) has become common. Good pain relief is central to early mobilization and greater patient satisfaction. Randomized controlled studies on pain relief following RALP are few and the role of spinal analgesia in pain management following robotic surgery has not been described. Techniques available for pain relief following RALP include spinal anesthesia with or without opiates, intravenous analgesia with morphine or a multimodal pain management technique using a combination of several analgesics. Spinal anesthesia and analgesia reduces the surgical stress and inflammatory response following laparoscopic colorectal surgery and may offer similar benefit even during RALP.
Early perioperative complications may cause postoperative morbidity following robotic surgery, and sometimes delay home discharge. Since all robotic operations in the pelvic region are performed in a deep Trendelenberg position, this can even have negative consequences for the heart, brain and the lungs. Cardiac complications in the form of minimal cardiac injury or mild heart failure have not been previously studied following RALP. Additionally, patients are sometimes delirious in the early postoperative period following RALP. The precise cause for this remains unclear and may be related to pain, cognitive dysfunction or an urge to pass urine despite a urinary catheter.
In addition to good postoperative pain relief, early postoperative mobilization and home discharge are important milestones in recovery of full function following major surgery. With improvement in surgical technique, the time has come to evaluate if RALP can be performed on an ambulatory basis. The main aims of this study are:
- Can RALP be performed on an ambulatory basis and patients ready to be discharged home at 8 pm?
- To determine if spinal anesthesia reduces pre-discharge pain intensity, stress response and other perioperative side effects.
- Is sufentanil or fentanyl the analgesic of choice when administered spinally together with bupivacaine as an analgesic.
- To determine the frequency and severity of cardiac and respiratory complications in the steep Trendelenberg position during RALP.
- To assess the quality of recovery, quality of life and activities of daily living following ambulatory RALP?
Detailed description
Prospective, randomized study blinded to observers (spinal or no-spinal). All formal approvals will be obtained from different authorities prior to study start. It will be registered in an international database (clinicaltrials.gov).
Patients > 18 years, ASA I-III, undergoing RALP will be included into the study. Patients on chronic opiate medication, those with contraindications to spinal anesthesia or allergy to any component drugs used during spinal anesthesia or other analgesics used in the study will be excluded. Patients living alone or having no adult at home to look after them during the first 24 h after home discharge will also be excluded. Informed written consent will be obtained from all patients. On the morning of surgery, all patients will receive paracetamol 1 g orally 1 h before planned surgery, and will be randomized to one of two groups as shown below:
Robot-assisted laparoscopic prostatectomy (RALP) (morning surgery)
- Group MM: This group of patients will not receive spinal anesthesia but have multimodal pain management including COX-2 blockers, pregabalin and oxycontin for pain management
- Group SF (Spinal/Fentanyl): Spinal anesthesia with bupivacaine 12.5 mg+fentanyl 15 ug Robot-assisted laparoscopic prostatectomy (RALP) (afternoon surgery)
- Group MM: This group of patients will not receive spinal anesthesia but have multimodal pain management including COX-2 blockers, pregabalin and oxycontin for pain management 2. Group SS (Spinal/Sufentanil): Spinal anesthesia with bupivacaine 12.5 mg+sufentanil 5 ug
Anesthesia will be standardized in all other aspects in all groups and basically include propofol for induction, rocuronium as muscle relaxant, sevoflurane and remifentanil for pain management and betamethasone + ondansetron as prophylaxis against post-operative nausea or vomiting (PONV). Surgery will also be standardized in all patients and follow the routines already established in the hospital.
At the end of surgery, patients will be transferred to the post-anesthesia care unit (PACU) where they will remain for 4 h observation and subsequently transferred to the general surgical wards for observation and discharge home. All measurement times will be taken from the end of surgery, which will be considered as t = 0.
The following parameters will be recorded:
- Total morphine consumption during 0-4, 4-home discharge and analgesic supplements after home discharge and up to 1 week will be recorded. Time to first morphine administration after surgery will be registered.
- Blood tests for measurement of cortisol, glucose, insulin, creatinine, NTproBNP and hsTnT will be taken at fixed time points before and after surgery.
- Pain intensity will be registered using NRS after 1, 2, 3, 4 and every 4 h until home discharge, and thereafter every 24 h for 1 week.
- All side effects (PONV, pruritus, respiratory depression, oxygen saturation and need for supplementary oxygen) and complications (bleeding, reoperation, pneumothorax etc.) will be recorded. Postoperative delirium will be assessed 0-2 h postoperatively. Prolonged PACU stay or re-admission to PACU will be registered. Clavien-Dindo classification for grade of complication will be registered as also Postoperative Morbidity score (POMS).
- Respiratory function will be recorded in the following ways: blood gas (after 1 and 4 h), saturation, spirometry, maximum expiratory pressure preoperatively and after 4 h. Need for supplementary oxygen to maintain SpO2 > 93% will be registered.
- Time to mobilization, time to discharge to the general ward (from PACU), "home readiness" (primary endpoint) and home discharge will be registered in accordance with standardized criteria. Criteria for home readiness: normal vital signs, pain intensity < 4 (NRS 0-10), minimal or no postoperative nausea or vomiting, able to sit, walk and go unhindered, no surgical complication (bleeding, fever), fully awake and able to follow instructions (normal cognition), normally functioning urinary catheter and an adult at home during the first 24 h after discharge home).
- Quality of Recovery 15 (QoR 24) will be measured before home-discharge and after 24 h using a standardized questionnaire.
- Quality of life will be measured preoperatively and after 7 and 30 days using the questionnaire EQ5D and WHODAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, observer-blinded
| Arm | Type | Receives |
|---|---|---|
| Analgesics, multimodal | Active comparator | Drug: AnalgesicsCombination of paracetamol, non-steroidal anti-inflammatory drug and morphine as analgesics |
| Bupivacaine | Experimental | Drug: BupivacaineSpinal anesthetic with bupivacain + fentanyl/sufentanil |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-3
- Elective robot-assisted laparoscopic prostatectomy Karolinska Hospital
Key exclusion criteria (4 listed)
- Communication limitations (language, mental)
- Chronic opiate use
- Allergy to NSAID
- Coagulation problems preventing administration of spinal analgesia
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 |
|---|---|---|
| BupivacaineAlso: Marcain spinalSpinal anesthesia with a combination of bupivacaine and fentanyl or sufentanil | Drug | Bupivacaine |
| AnalgesicsAlso: paracetamol + NSAID + morphineCombination of paracetamol + non-steroidal anti-inflammatory drug + morphine to all patients | Drug | Analgesics, multimodal |
Primary outcome
Number of patients ready for home discharge at 8 pm after surgery
Time frame: With 12 h of surgery start
Number of patients ready to be discharged home after surgery when using a standardized home-discharge criteria
5 secondary outcomes
Pain intensity
Time frame: 7 days postoperatively
Stress markers in plasma
Time frame: 24 hours
Quality of Recovery
Time frame: 3 days postoperatively
Quality of life after surgery
Time frame: 30 days postoperatively
Amount (mg) of morphine administered as rescue analgesic at 12 and at 24 h
Time frame: At 12 hours and 24 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 22 Jun 2022.
- Individual participant dataSharing planned: Undecided. Not known currently
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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.
Håkan Björne, MD, PhD study director
Karolinska Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine and Analgesics in people with Radical Prostatectomy and Postoperative Pain, run by Karolinska Institutet at 2 sites in Sweden.
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 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients ready for home discharge at 8 pm after surgery (time frame: With 12 h of surgery start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.