Patient-Controlled Sedation in Port Implantation (PACSPI 2)-A Randomised Clinical Trial

Area of Science:

• Anesthesiology
• Oncology
• Surgical Procedures

Background:

• Optimizing pain management during subcutaneous venous port (SVP) implantation is crucial for patient-centered cancer care.
• Evidence-based methods to minimize intraoperative pain during SVP placement are underexplored.
• Local anaesthesia (LA) is standard, but additional analgesia may improve patient experience.

Purpose of the Study:

• To evaluate the clinical effectiveness and safety of propofol-alfentanil patient-controlled sedation (PCS) as an adjunct to LA for pain reduction during SVP implantation.
• To compare intraoperative pain scores, patient satisfaction, and procedural conditions between LA+PCS and LA alone.
• To assess safety outcomes including respiratory and hemodynamic complications.

Main Methods:

• A randomized clinical trial involving 340 adult cancer patients at two Swedish anesthesiology departments.
• Patients received either LA + PCS or LA alone for SVP implantation.
• The primary outcome was the maximum intraoperative pain score using an 11-point numeric rating scale (NRS).

Main Results:

• Median intraoperative NRS pain scores were similar between groups (2 [0-3] vs. 2 [0-3], p=0.292).
• Pain scores ≥4 were reported in 22.9% of the LA+PCS group and 22.2% of the LA group (OR 0.96; p=0.872).
• Optimal procedural conditions were more frequent with LA+PCS (96.4% vs. 82.0%, p<0.001), with no significant difference in patient satisfaction (p=0.102).

Conclusions:

• Propofol-alfentanil PCS does not significantly reduce intraoperative pain during SVP implantation.
• Routine use of propofol-alfentanil PCS for pain reduction during SVP implantation cannot be recommended.
• PCS may be offered to patients who prefer procedural sedation, with careful consideration of safety outcomes.