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

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?

Conditions

• Radical Prostatectomy
• Postoperative Pain

Interventions

DRUG

Bupivacaine

Spinal anesthesia with a combination of bupivacaine and fentanyl or sufentanil

DRUG

Analgesics

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

Sponsors & Collaborators

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Håkan Björne, MD, PhD · Karolinska Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2022-03-29

Completion

2022-03-29

Countries

• Sweden

Study Locations