Postoperative pain and recovery after robot assisted laparoscopic prostatectomy - a single-blinded randomized controlled trial

Postoperative pain and recovery after robot assisted laparoscopic prostatectomy - a single-blinded randomized controlled trial - RAPiD

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003806-23-SE

Enrollment

200

Registered

2018-10-01

Start date

2018-11-20

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain and recovery after robot assisted laparoscopic prostatectomy MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Sufenta 5 mikrogram/ml Product Name: Sufenta 5 mikrogram/ml Pharmaceutical Form: Injection Trade Name: Marcain spinal Product Name: Marcain spinal Pharmaceutical Form: Injection Trade Na

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients > 18 years ASA I-III undergoing RALP signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: • Chronic opiate medication (> 3 months preoperatively) • Contraindication to spinal anesthesia or allergy to any component drugs used during spinal anesthesia or any other contraindications to the use of other study drugs used • Patient with uncontrolled renal, liver, heart failure or ischemic heart disease • Ongoing gastric ulcer • GI bleeding or other forms of acute bleeding/shock • Pre-existing respiratory depression • Sepsis or other ongoing infections • Coagulation problems or simultaneous administration of therapeutic doses of anticoagulants • Patients with speech, language or cognitive difficulties • Patients living alone or having no adult at home to look after them during the first 24 h after home discharge

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if a larger proportion of patients having spinal anaesthesia during RALP performed in the morning are ready to be discharged home in the evening (8 pm) compared to patients not having the spinal anaesthesia.;Secondary Objective: To determine if spinal anaesthesia reduces pre-discharge pain intensity (at rest and movement), stress response and other perioperative side effects such as urge to pass urine, delirium, nausea and vomiting and analgesic supplements at pre-determined time points. To determine the frequency and severity of cardiac and/or 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. ;Primary end point(s): Number of patients that are ready to be discharged home at 8 pm on the day of surgery for patients having surgery in the morning, evaluated by strict discharge criteria.;Timepoint(s) of evaluation of this end point: 8 pm Day 0	—

Measure

Time frame

Main Objective: To investigate if a larger proportion of patients having spinal anaesthesia during RALP performed in the morning are ready to be discharged home in the evening (8 pm) compared to patients not having the spinal anaesthesia.;Secondary Objective: To determine if spinal anaesthesia reduces pre-discharge pain intensity (at rest and movement), stress response and other perioperative side effects such as urge to pass urine, delirium, nausea and vomiting and analgesic supplements at pre-determined time points. To determine the frequency and severity of cardiac and/or 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. ;Primary end point(s): Number of patients that are ready to be discharged home at 8 pm on the day of surgery for patients having surgery in the morning, evaluated by strict discharge criteria.;Timepoint(s) of evaluation of this end point: 8 pm Day 0

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Active treatment period and follow up period;Secondary end point(s): Pain and pain management measured at preop, arrival to postop, 4-6 h after surgery, at arrival to general surgical ward, at 24h, 48 h, and thereafter every 24 h until 1 week and lastly at 1 month. Supplementary analgesic consumption during 0-4 h, 4-24 h and during 24 h-1 week. Perioperative stress (measured by plasma cortisol and glucose) before surgery, at 4-6 h and at 24 h and renal function (measured by serum creatinine and eGFR) preoperatively and before discharge. Any complications that occur before and after discharge. All complications assessed by Clavien-Dindo classification and Postoperative Morbidity Score (POMS) during the first 30 days after surgery. Adverse reactions in the form of nausea and/or vomiting, pruritis, impaired respiratory function, etc. Time for mobilization evaluated by specific discharge criteria at 8 pm and after 24 h, actual timepoint when the patient was discharged home. Quality of recovery (QoR) and quality of life (QoL) through standardized and validated surveys preop, at predetermined time intervals. Minimal cardiac injury measured by troponin T and NT-proBNP preoperatively and 4-6 h after end of surgery, in a subset of 40 patients (20 x 2).	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Active treatment period and follow up period;Secondary end point(s): Pain and pain management measured at preop, arrival to postop, 4-6 h after surgery, at arrival to general surgical ward, at 24h, 48 h, and thereafter every 24 h until 1 week and lastly at 1 month. Supplementary analgesic consumption during 0-4 h, 4-24 h and during 24 h-1 week. Perioperative stress (measured by plasma cortisol and glucose) before surgery, at 4-6 h and at 24 h and renal function (measured by serum creatinine and eGFR) preoperatively and before discharge. Any complications that occur before and after discharge. All complications assessed by Clavien-Dindo classification and Postoperative Morbidity Score (POMS) during the first 30 days after surgery. Adverse reactions in the form of nausea and/or vomiting, pruritis, impaired respiratory function, etc. Time for mobilization evaluated by specific discharge criteria at 8 pm and after 24 h, actual timepoint when the patient was discharged home. Quality of recovery (QoR) and quality of life (QoL) through standardized and validated surveys preop, at predetermined time intervals. Minimal cardiac injury measured by troponin T and NT-proBNP preoperatively and 4-6 h after end of surgery, in a subset of 40 patients (20 x 2).

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Countries

Sweden

Contacts

Public ContactClinical Trial Information

Karolinska University Hospital

anil.gupta@sll.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026