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Trial record 4 of 149 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

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
Sponsor:
Information provided by (Responsible Party):
Anil Gupta, Karolinska Institutet

Brief 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. 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:

  1. Can RALP be performed on an ambulatory basis and patients ready to be discharged home at 8 pm?
  2. To determine if spinal anesthesia reduces pre-discharge pain intensity, stress response and other perioperative side effects.
  3. Is sufentanil or fentanyl the analgesic of choice when administered spinally together with bupivacaine as an analgesic.
  4. To determine the frequency and severity of cardiac and respiratory complications in the steep Trendelenberg position during RALP.
  5. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Analgesics, multimodal
Combination of paracetamol, non-steroidal anti-inflammatory drug and morphine as analgesics
Drug: Analgesics
Combination of paracetamol + non-steroidal anti-inflammatory drug + morphine to all patients
Other Name: paracetamol + NSAID + morphine

Experimental: Bupivacaine
Spinal anesthetic with bupivacain + fentanyl/sufentanil
Drug: Bupivacaine
Spinal anesthesia with a combination of bupivacaine and fentanyl or sufentanil
Other Name: Marcain spinal




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 7 days postoperatively ]
    Intensity of pain recorded using numeric rating score at defined time intervals postoperatively

  2. Stress markers in plasma [ Time Frame: 24 hours ]
    Blood glucose, cortisol and insulin

  3. Quality of Recovery [ Time Frame: 3 days postoperatively ]
    Quality of recovery will be measured at defined time intervals using a standardized questionnaire

  4. 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

  5. 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)



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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only males undergo this procedure
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1-3
  • Elective robot-assisted laparoscopic prostatectomy Karolinska Hospital

Exclusion Criteria:

  • Communication limitations (language, mental)
  • Chronic opiate use
  • Allergy to NSAID
  • Coagulation problems preventing administration of spinal analgesia

Information from the National Library of Medicine

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


Contacts
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Contact: Anil Gupta, MD, PhD +46 8 51770387 anil.gupta@sll.se
Contact: Anna Wennmo, MD +46 8 5171000 anna.wennmo@sll.se

Locations
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Sweden
Karolinska Hospital, Solna Recruiting
Stockholm, Sweden, 17176
Contact: Anna Grannström, BSc    08-5170000 ext 74416    anna.grannstrom@sll.se   
Contact: Anna Schening, BSc    08-5170000 ext 74416    anna.schening@sll.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Director: Håkan Björne, MD, PhD Karolinska Hospital

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Responsible Party: Anil Gupta, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03639389     History of Changes
Other Study ID Numbers: 2018-06
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not known currently

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anil Gupta, Karolinska Institutet:
Robot assisted surgery
Prostatectomy
Spinal anesthesia
Postoperative pain
Home discharge

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Morphine
Acetaminophen
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents
Antirheumatic Agents