Modified Radical Mastectomy, Quality of Recovery (QoR-15)
Conditions
Keywords
subtransverse interligamentary plane block, modified radical mastectomy, quality of recovery
Brief summary
This prospective randomized controlled double blinded non-inferiority study will be carried out in Tanta University Hospitals for duration of 6 months from June 2026 to December 2026 on 60 female patients scheduled for unilatral modified radical mastectomy under general anesthesia.
Detailed description
Breast carcinoma is a common malignancy in females, with modified radical mastectomy (MRM) being the most frequently performed surgery. Surgical intervention is accompanied by significant challenges such as postoperative pain and stress, potentially leading to prolonged hospitalizations and complications. Previous studies had demonstrated that thoracic paravertebral block (TPVB) was effective in diminishing opioid requirements for patients undergoing breast surgery. TPVB is technically challenging, requiring skilled healthcare professionals and the narrow paravertebral space, located between the superior costotransverse ligament (SCTL) and the parietal pleura, poses a risk of inadvertent pleural puncture and vascular damage, and increased the potential for pneumothorax and haematoma. The Subtransverse process Interligamentary (STIL) plane block is a recently introduced technique that holds promise as an alternative to TPVB. STIL plane block specifically targets the region adjacent to the paravertebral space, rather than directly penetrating it, which theoretically diminishes the potential risks of inadvertent pneumothorax and hematoma compared with TPVB. Additionally, due to its close anatomical proximity to the paravertebral space, the STIL plane block may facilitate a more straightforward dispersion of local anaesthetics into this area. Research has also confirmed that the block achieved with STIL plane block is effective in providing adequate pain relief for breast surgeries. Also it was associated with decreased postoperative opioid consumption compared to the ESP block in patients undergoing MRM. With the improvement of anaesthesia technology, the quality of patient recovery is no longer solely measured by the success of the surgery or the discharge rate, but is increasingly oriented towards a "patient-centered" approach that focuses on the safety, comfort, and overall quality of recovery throughout the perioperative period. In light of the growing emphasis on improving postoperative quality of recovery while ensuring patient safety, we hypothesize that the STIL plane block will demonstrate non-inferiority to the thoracic PVB in terms of postoperative quality of recovery and analgesia in patients undergoing MRM.
Interventions
PROCEDURESubtransverse interligamentary plane block (STIL)
Patients will receieve u;trasound guided subtransverse interligamentary plane block
PROCEDUREThoracic paravertebral block (TPVB)
Patients will receieve ultrasound guided thoracic paravertebral block
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult female patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) Physical Status I - III, who were scheduled for unilateral MRM surgery under general anesthesia and able to understand and complete the QoR-15 questionnaire
Exclusion criteria
* • Patients declined to participate in the trial. * History of allergy to the used local anesthetic (LA) drugs. * Patients with cutaneous lesions at the needle entry point. * Coagulopathy or current anticoagulant therapy contraindicating regional block. * Patients with severe hepatic, renal, cardiac, or respiratory disease. * Psychiatric or cognitive disorder interfering with QoR-15 assessment * Chronic opioid use or chronic pain syndrome. * Failed block. * Morbid obesity (body mass index \>40 kg/m2) * Intraoperative major complications requiring postoperative ICU admission. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative quality of recovery | It will be measured 24 hours after surgery | Postoperative quality of recovery assessed using the Quality of Recovery-15 questionnaire which provides a global score of recovery after anesthesia and surgery by evaluating pain, comfort, emotions, independence, and support. The total score ranges from 0 to 150. Higher score = better recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score | It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively | Postoperative pain score using numerical rating scale (NRS) score The NRS is an 11-point pain scale ranging from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain. Participants are asked to rate their pain intensity by choosing the number that best represents their pain level. |
| Time to first rescue analgesia | Postoperatively the time interval from the end of surgery until need of rescue analgesia will be recorded | Time interval from the end of surgery until need of rescue analgesia |
| Total postoperative opioid consumption in the first 24 hours | Total needed postoperative opioid dosing during the first 24 hours will recorded | Total postoperative opioid consumption in the first 24 hours will be recorded |
| Incidence of postoperative nausea and vomiting | Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours | Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours |
| The degree of patient satisfaction | it will be recorded postoperatively and 24 hours after surgery | The degree of patient satisfaction using level of satisfaction regarding the analgesia regimen using a 5 point Likert scale, where 1 indicates "extremely dissatisfied", 2 "unsatisfied", 3 "unsure", 4 "satisfied", and 5 "extremely satisfied" |
| Block performance time | Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection | Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection will be recorded |
Countries
Egypt
Contacts
CONTACTMai Salah Salem, MD anesthesia, SIC
Outcome results
None listed