Severity classification of the quality of recovery-15 score-An observational study.
Jakob Kleif, Ismail Gögenur
https://pubmed.ncbi.nlm.nih.gov/29605019/Actively Recruiting
Led by Dharmais National Cancer Center Hospital · Updated on 2026-07-31
72
Participants Needed
1
Research Sites
4 weeks
Total Duration
The trial investigates pain management after mastectomy for breast cancer, focusing on comparing two regional analgesia techniques. It aims to evaluate the pain relief and quality of recovery between a combined Pectoral Nerve II PECS II and Superficial Parasternal Intercostal Plane PIP block versus the standard Thoracic Paravertebral Block TPVB. This study addresses risks related to TPVB and explores whether the combined blocks can provide effective pain control with fewer complications. Participants are randomly assigned to one of two groups following general anesthesia induction one receiving the combined ultrasound-guided PECS II and PIP blocks with specific doses of 0.25% Bupivacaine, and the other receiving the ultrasound-guided TPVB at thoracic levels T4 and T6. Both groups receive standardized general anesthesia and intraoperative monitoring. Postoperative pain management includes oral paracetamol, IV ketorolac, and IV Morphine via patient-controlled analgesia PCA. During the 24-hour postoperative period, participants have their pain levels assessed at rest and movement using the Numeric Rating Scale NRS at multiple time points. Researchers also measure total opioid use, time to first analgesic request, and quality of recovery using the QoR-15 questionnaire. Monitoring for complications related to nerve blocks, such as local anesthetic toxicity and pneumothorax, is conducted, ensuring comprehensive safety and efficacy evaluation throughout the study.
CONDITIONS
Analgesic Efficacy of Combined PECS II and PIP Block Versus Thoracic Paravertebral Block Post-Mastectomy
A
Annisa Annisa, Anesthesiologist
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Dharmais National Cancer Center Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants receive either the combined PECS II and PIP blocks or the Thoracic Paravertebral Block after general anesthesia induction before surgery. Standard anesthesia and monitoring continue during surgery.
1 visit (in-person)
Duration - 24 hours post-surgery
Pain levels and quality of recovery are assessed at multiple times within 24 hours after surgery. Opioid use and any complications are monitored closely during this period.
Multiple assessments over 24 hours
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Jakob Kleif, Ismail Gögenur
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Lead Sponsor