Facial Plane Blocks, Modified Radical Mastectomy, Post Operative Pain, Acute
Conditions
Keywords
postoperative pain, regional anesthesia, Modified radical mastectomy, opioid free analgesia, facial plan block, serratus posterior superior intercostal plane block
Brief summary
The aim of researchers is to compare the effects of three different local anesthetic concentrations and volumes on opioid consumption, postoperative analgesic efficacy, and pain scores during ultrasound-guided SPSIP blocks in patients undergoing modified radical mastectomy. Additionally, we aim to map and identify the dermatomal areas where different concentrations and volumes of SPSIP blocks provide analgesia.
Detailed description
The researchers' hypothesis is that a lower concentration but higher volume of SPSIP block could provide similar analgesic efficacy to a higher concentration and lower volume block, while also improving the safety profile in terms of local anesthetic systemic toxicity by reducing the total local anesthetic load. In other words, we believe that using less than the 0.25% bupivacaine used in previous studies on this block could provide similar analgesic efficacy. This is because, in fascial plane blocks, separating the fascia is as important a technique as the local anesthetic administered. Facial plane blocks are volume-dependent blocks. The Modified Aldrete scoring system is a routine assessment performed in our clinic's postoperative recovery room to determine whether a patient has recovered. Patients with an NRS score of 4 or higher, despite routine analgesia, will receive 50 mg tramadol hydrochloride as a rescue analgesic, administered intravenously over 30 minutes in 150 ml of saline solution.
Interventions
PROCEDURESerratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine
A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.1875% bupivacaine (15 ml of the drug + 25 ml of isotonic solution).
PROCEDURESerratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine
A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.15% bupivacaine (15 ml of the drug + 35 ml of isotonic solution).
PROCEDURESerratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine
A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 30 ml of 0.25% bupivacaine (15 ml of the drug + 15 ml of isotonic solution).
Sponsors
Cumhuriyet University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The study included adult patients over 18 years of age who underwent modified radical mastectomy under general anesthesia and were classified in risk groups I-II-III according to the American Society of Anesthesiologists (ASA) risk classification.
Exclusion criteria
* patients with coagulopathy, * patients with signs of infection at the block application site, * patients with ASA IV * patients with known allergies to any of the study drugs, * patients with ineffective block * patients who could not cooperate during postoperative pain assessment * patients who wanted to withdraw from the study, * patients with alcohol and drug addiction, * patients with musculoskeletal abnormalities * patients with kidney and liver failure * patients with obesity (body mass ≥ 35 kg/m2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total tramadol consumption | Postoperative 24 hours | Postoperative total analgesic need was recorded as "milligram" in unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatome Area | 30th minute after the block | Thirty minutes after the block procedure, we will perform a pinprick test by inserting a sterile needle from the tip of the syringe into the patient's skin and recording the areas where skin analgesia has developed. |
| Numeric Rating Scale (NRS) Scores | Postoperative 24 hours | Description: Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain |
Countries
Turkey (Türkiye)
Contacts
CONTACTOĞUZ GÜNDOĞDU
Outcome results
None listed