Tanta university hospital
Tanta, 31527, Egypt
NCT Number: NCT07647367
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.
Trial opening soon.
Get Notified18 year–65 year
Female
Interventional
Not applicable
Tanta, 31527, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receieve u;trasound guided subtransverse interligamentary plane block
Other names: Arm 1
Patients will receieve ultrasound guided thoracic paravertebral block
Time frame: 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.
Time frame: 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 frame: 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
Time frame: Total needed postoperative opioid dosing during the first 24 hours will recorded
Total postoperative opioid consumption in the first 24 hours will be recorded
Time frame: 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
Time frame: 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"
Time frame: 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
Contact information is provided by the study sponsor or research team.
Tanta University
Other
Ultrasound-Guided Subtransverse Interligamentary Plane Block Versus Thoracic Paravertebral Block for Quality of Recovery After Modified Radical Mastectomy: A Randomized Non-Inferiority Trial
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