Perioperative pain management
Conditions
Interventions
Group PCA+ITM:Opioid-based patient-controlled analgesia (PCA)+Intrathecal morphine (ITM)
Group PCA+Sham ITM:Usual analgesia with opioid-based patient-controlled analgesia (PCA)+Sham ITM
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: ? Age 18 years or over ? Elective (i.e., planned) laparoscopic or robotic abdominal surgery within one or more of the following specialties: o Colorectal o Gynaecology o Hepato-biliary (including pancreatic surgery) o Renal o Upper gastrointestinal o Urology/Renal ? Anticipated duration of surgery = 2 hours (from knife-to-skin to end of wound closure) ? Anticipated hospital stays = 24 hours from the midnight of the day of surgery
Exclusion criteria
Exclusion criteria: ? Allergy to study drugs ? Anatomical factors making intrathecal injection impossible ? Anticipated requirement for postoperative invasive ventilation ? American Society of Anesthesiologists (ASA) Score >IV ? Coagulopathies (i.e. INR>1.3 and/or platelet count <100*10^9) ? Cognitive impairment leading to inability to complete the study’s questionnaires ? Drugs affecting coagulation (except aspirin), which have not been suitably and timely paused preoperatively ? Infection near the site of intrathecal injection ? Ongoing sepsis ? Patients previously included in the trial and who need to return to theatre for a new abdominal surgery ? Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Recovery at 24 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| European Quality of life-5 Dimensions-5 Level (EQ-5D-5L);Quality of recovery;Time to tracheal extubation;Worst pain in last 24 hours;Incidence of Postoperative pulmonary complications;Incidence of respiratory depression;Total opioid consumption;Incidence of urinary retention ;Anaesthesia-related discomfort (incidence of nausea and/or vomiting, drowsiness, shivering, pruritus);Patient’s satisfaction;Time (in days) to get out of bed;Number of antiemetic doses required postoperative;Length of Hospital Stay;Days at Home After Surgery;Mortality; | — |
Countries
China
Contacts
Public ContactXia Feng
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed