Postoperative Pain, Recovery and Discharge Following Robot-assisted Laparoscopic Prostatectomy
Märksõnad
Abstraktne
Kirjeldus
Prospective, randomized study blinded to observers (spinal or no-spinal). All formal approvals will be obtained from different authorities prior to study start. It will be registered in an international database (clinicaltrials.gov).
Patients > 18 years, ASA I-III, undergoing RALP will be included into the study. Patients on chronic opiate medication, those with contraindications to spinal anesthesia or allergy to any component drugs used during spinal anesthesia or other analgesics used in the study will be excluded. Patients living alone or having no adult at home to look after them during the first 24 h after home discharge will also be excluded. Informed written consent will be obtained from all patients. On the morning of surgery, all patients will receive paracetamol 1 g orally 1 h before planned surgery, and will be randomized to one of two groups as shown below:
Robot-assisted laparoscopic prostatectomy (RALP) (morning surgery)
1. Group MM: This group of patients will not receive spinal anesthesia but have multimodal pain management including COX-2 blockers, pregabalin and oxycontin for pain management
2. Group SF (Spinal/Fentanyl): Spinal anesthesia with bupivacaine 12.5 mg+fentanyl 15 ug Robot-assisted laparoscopic prostatectomy (RALP) (afternoon surgery)
1. Group MM: This group of patients will not receive spinal anesthesia but have multimodal pain management including COX-2 blockers, pregabalin and oxycontin for pain management 2. Group SS (Spinal/Sufentanil): Spinal anesthesia with bupivacaine 12.5 mg+sufentanil 5 ug
Anesthesia will be standardized in all other aspects in all groups and basically include propofol for induction, rocuronium as muscle relaxant, sevoflurane and remifentanil for pain management and betamethasone + ondansetron as prophylaxis against post-operative nausea or vomiting (PONV). Surgery will also be standardized in all patients and follow the routines already established in the hospital.
At the end of surgery, patients will be transferred to the post-anesthesia care unit (PACU) where they will remain for 4 h observation and subsequently transferred to the general surgical wards for observation and discharge home. All measurement times will be taken from the end of surgery, which will be considered as t = 0.
The following parameters will be recorded:
1. Total morphine consumption during 0-4, 4-home discharge and analgesic supplements after home discharge and up to 1 week will be recorded. Time to first morphine administration after surgery will be registered.
2. Blood tests for measurement of cortisol, glucose, insulin, creatinine, NTproBNP and hsTnT will be taken at fixed time points before and after surgery.
3. Pain intensity will be registered using NRS after 1, 2, 3, 4 and every 4 h until home discharge, and thereafter every 24 h for 1 week.
4. All side effects (PONV, pruritus, respiratory depression, oxygen saturation and need for supplementary oxygen) and complications (bleeding, reoperation, pneumothorax etc.) will be recorded. Postoperative delirium will be assessed 0-2 h postoperatively. Prolonged PACU stay or re-admission to PACU will be registered. Clavien-Dindo classification for grade of complication will be registered as also Postoperative Morbidity score (POMS).
5. Respiratory function will be recorded in the following ways: blood gas (after 1 and 4 h), saturation, spirometry, maximum expiratory pressure preoperatively and after 4 h. Need for supplementary oxygen to maintain SpO2 > 93% will be registered.
6. Time to mobilization, time to discharge to the general ward (from PACU), "home readiness" (primary endpoint) and home discharge will be registered in accordance with standardized criteria. Criteria for home readiness: normal vital signs, pain intensity < 4 (NRS 0-10), minimal or no postoperative nausea or vomiting, able to sit, walk and go unhindered, no surgical complication (bleeding, fever), fully awake and able to follow instructions (normal cognition), normally functioning urinary catheter and an adult at home during the first 24 h after discharge home).
7. Quality of Recovery 15 (QoR 24) will be measured before home-discharge and after 24 h using a standardized questionnaire.
8. Quality of life will be measured preoperatively and after 7 and 30 days using the questionnaire EQ5D and WHODAS.
Kuupäevad
| Viimati kinnitatud: | 01/31/2020 |
| Esmalt esitatud: | 08/05/2018 |
| Hinnanguline registreerumine on esitatud: | 08/19/2018 |
| Esmalt postitatud: | 08/20/2018 |
| Viimane värskendus on esitatud: | 02/18/2020 |
| Viimati värskendus postitatud: | 02/19/2020 |
| Õppe tegelik alguskuupäev: | 12/31/2018 |
| Eeldatav esmane lõpetamise kuupäev: | 11/30/2020 |
| Eeldatav uuringu lõpetamise kuupäev: | 08/31/2021 |
Seisund või haigus
Sekkumine / ravi
Drug: Bupivacaine
Drug: Analgesics, multimodal
Faas
Käerühmad
| Arm | Sekkumine / ravi |
|---|---|
| Active Comparator: Analgesics, multimodal Combination of paracetamol, non-steroidal anti-inflammatory drug and morphine as analgesics | Drug: Analgesics, multimodal Combination of paracetamol + non-steroidal anti-inflammatory drug + morphine to all patients |
| Experimental: Bupivacaine Spinal anesthetic with bupivacain + fentanyl/sufentanil | Drug: Bupivacaine Spinal anesthesia with a combination of bupivacaine and fentanyl or sufentanil |
Abikõlblikkuse kriteeriumid
| Õppimiseks sobivad vanused | 45 Years To 45 Years |
| Uuringuks kõlblikud sood | Male |
| Võtab vastu tervislikke vabatahtlikke | Jah |
| Kriteeriumid | 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 |
Tulemus
Esmased tulemusnäitajad
1. Number of patients ready for home discharge at 8 pm after surgery [With 12 h of surgery start]
Sekundaarsed tulemusmõõdud
1. Pain intensity [7 days postoperatively]
2. Stress markers in plasma [24 hours]
3. Quality of Recovery [3 days postoperatively]
4. Quality of life after surgery [30 days postoperatively]
5. Amount (mg) of morphine administered as rescue analgesic at 12 and at 24 h [At 12 hours and 24 hours postoperatively]
