NCT03639389: RAPID

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

Completed Phase 3 Last updated 22 June 2022

What this trial tests

Phase 3 trial testing Bupivacaine in Radical Prostatectomy in 211 participants. Completed in 29 March 2022.

Timeline

1 January 2019

Primary endpoint
29 March 2022

29 March 2022

Quick facts

Lead sponsor	Karolinska Institutet
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	211
Start date	1 January 2019
Primary completion	29 March 2022
Estimated completion	29 March 2022
Sites	2 locations across Sweden

Drugs / interventions tested

• Bupivacaine (BUPIVACAINE) — full drug profile →
• Analgesics — full drug profile →

Conditions studied

• Radical Prostatectomy — all drugs for Radical Prostatectomy →
• Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

Karolinska Institutet

Who can join

Adults 45 to 85, male only, with Radical Prostatectomy or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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?

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.