Postoperative Pain, Recovery and Discharge Following Robot-assisted Laparoscopic Prostatectomy (RAPID)
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|ClinicalTrials.gov Identifier: NCT03639389|
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : January 11, 2019
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?
|Condition or disease||Intervention/treatment||Phase|
|Radical Prostatectomy Postoperative Pain||Drug: Bupivacaine Drug: Analgesics||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomized, observer-blinded|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome observer blinded to method of analgesia (spinal/no-spinal)|
|Official Title:||Randomised Comparison Between Spinal/GA or GA Alone Following Robot-assisted Laparoscopic Prostatectomy. Stress Response, Pain, Recovery and Home Discharge|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2021|
Active Comparator: Analgesics, multimodal
Combination of paracetamol, non-steroidal anti-inflammatory drug and morphine as analgesics
Combination of paracetamol + non-steroidal anti-inflammatory drug + morphine to all patients
Other Name: paracetamol + NSAID + morphine
Spinal anesthetic with bupivacain + fentanyl/sufentanil
Spinal anesthesia with a combination of bupivacaine and fentanyl or sufentanil
Other Name: Marcain spinal
- 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
- Pain intensity [ Time Frame: 7 days postoperatively ]Intensity of pain recorded using numeric rating score at defined time intervals postoperatively
- Stress markers in plasma [ Time Frame: 24 hours ]Blood glucose, cortisol and insulin
- Quality of Recovery [ Time Frame: 3 days postoperatively ]Quality of recovery will be measured at defined time intervals using a standardized questionnaire
- Quality of life after surgery [ Time Frame: 30 days postoperatively ]Quality of life will be measured at defined time intervals pre- and postoperatively using a standardized questionnaire
- Amount (mg) of morphine administered as rescue analgesic at 12 and at 24 h [ Time Frame: At 12 hours and 24 hours postoperatively ]Total amount of rescue analgesics (morphine) administered to achieve good analgesia and mild pain (NRS < 4)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639389
|Contact: Anil Gupta, MD, PhD||+46 8 firstname.lastname@example.org|
|Contact: Anna Wennmo, MD||+46 8 email@example.com|
|Karolinska Hospital, Solna||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Anna Grannström, BSc 08-5170000 ext 74416 firstname.lastname@example.org|
|Contact: Anna Schening, BSc 08-5170000 ext 74416 email@example.com|
|Study Director:||Håkan Björne, MD, PhD||Karolinska Hospital|