Postoperative Pain, Recovery and Discharge Following Robot-assisted Laparoscopic Prostatectomy

NCT03639389 | Completed Phase 3 DMC

• 1 other identifier: 2018-06
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 2

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

Conditions

Radical Prostatectomy; Postoperative Pain

Keywords

Robot assisted surgery; Prostatectomy; Spinal anesthesia; Postoperative pain; Home discharge

Outcome Measures

Primary Outcomes (1)

• 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

  With 12 h of surgery start

Secondary Outcomes (5)

• Pain intensity

  7 days postoperatively

• Stress markers in plasma

  24 hours

• Quality of Recovery

  3 days postoperatively

• Quality of life after surgery

  30 days postoperatively

• Amount (mg) of morphine administered as rescue analgesic at 12 and at 24 h

  At 12 hours and 24 hours postoperatively

Study Arms (2)

Analgesics, multimodal

ACTIVE COMPARATOR

Combination of paracetamol, non-steroidal anti-inflammatory drug and morphine as analgesics

Drug: Analgesics

Bupivacaine

EXPERIMENTAL

Spinal anesthetic with bupivacain + fentanyl/sufentanil

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Spinal anesthesia with a combination of bupivacaine and fentanyl or sufentanil

Also known as: Marcain spinal

Bupivacaine

Analgesics DRUG

Combination of paracetamol + non-steroidal anti-inflammatory drug + morphine to all patients

Also known as: paracetamol + NSAID + morphine

Analgesics, multimodal

Eligibility Criteria

• Age: 45 Years - 85 Years
• Gender Eligibility Details: Only males undergo this procedure
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Karolinska Hospital, Solna

Stockholm, 17176, Sweden

Location

Capio St Görans Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Analgesics; Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Acetanilides; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Håkan Björne, MD, PhD

  Karolinska Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome observer blinded to method of analgesia (spinal/no-spinal)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective, randomized, observer-blinded

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 21, 2018
• Study Start: January 1, 2019
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

SE (2)