Clinical trial NCT05499897: The Effect of Interscalene Block on Wound Healing and Immunity in Open Shoulder Surgeries
Official title: Interscalene Block Relationship With Immunity and Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound gıided Interscalene Block
Keywords: peripheral nerve block
general anesthesia
immunity
wound healing
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized,single blind
Primary purpose: OTHER

Brief summary: In this study, investigators hypothesize the following: How will the amounts of these factors, which are involved in fibrin formation and wound healing, change after the block? If there is an increase, investigators can conclude that it has a positive effect on wound healing and immunity, if there is no change, it has no effect on wound healing and immunity.

Detailed description: Study design and participants

* 40 participants
* Between 18-65
* ASA physical status I-II
* Scheduled for elective open shoulder surgery
* From July 2022 Exclusion criteria included;
* coagulation disorders
* neuropathic disorders
* diaphragmatic paralysis
* allergy to local anesthetics
* severe cardiopulmonary disease
* psychiatric disorders
* pregnancy
* severe obesity (body mass index \>35kg/m2 )
* previous shoulder surgery
* a failed ISB
* liver failure
* kidney failure
* receiving effective treatment on immunity
* Immunosuppression
* Persons requiring intraoperative blood transfusion Randomization

Participants will be randomized into 2 groups using the closed envelope method:

Group GA (Participants who will be operated under general anesthesia): Standard ASA monitoring, induction with 2 mg/kg propofol, 0.6mg/kg rocuronium bromide, 1µcg/kg fentanyl. Maintenance with 2MAC sevoflurane + 40% air mixture. Flow 2L/min. Before extubation, 1 mg/kg tramadol and 15 mg/kg paracetamol will be administered iv. Paracetamol will be repeated at 8 hour intervals.

Group IS (Participants who will undergo surgery with interscalen block): 20 ml of 0.25% bupivacaine for anesthesia. Before being taken to the postoperative unit, 1 mg/kg tramadol and 15 mg/kg paracetamol will be administered iv. Paracetamol will be repeated at 8 hour intervals.

A researcher not associated with the study will apply the random allocation sequence using a computer-generated randomization table. The allocation ratio will be 1:1 and sealed opaque envelopes will be used to conceal the allocations. Outcome assessors, and surgeons will be unaware of the group assignments.

Preoperative Management Before half an hour surgery, blood account will be done for both groups. Platelet count will be done and PDGF (Platelet growth factor), TGF-α (transforming growth factor), EGF (epidermal growth factor), IL-1/IL-2, TNF-α (tumor necrosis factor alpha) will be analysed. The same analyses will be repeated after 24 and 48 hours surgery. These tests will be done 3 times for each patient: preop, postop 24h and postop 48h.

Anesthesia Standard ASA monitors will be used throughout the surgery. Group IS patients will receive a standardized single injection ISB under ultrasound guidance, administered by one of two experienced anesthesiologists (AET or NY). Participants will receive 2mg of midazolam and 50µg of fentanyl for sedation before the block procedure. Each participant will be placed in the supine position with the head turned away from the side to be blocked. A high-frequency linear transducer ultrasound probe will be placed in supraclavicular fossa to identify the subclavian artery and brachial plexus under sterile conditions. 20 ml of 0.25% bupivacaine will be applied with 80mm, 22 gauge needle in-plane technic around the C5 and C6 roots or the superior trunk . Localization will be confirmed by ultrasound visualization of injectate 5mL saline. Before being taken to the postoperative unit, 1 mg/kg tramadol and 15 mg/kg paracetamol will be administered iv. Paracetamol will be repeated at 8 hour intervals.

Group GA participants will be operated under general anesthesia. 2 mg/kg propofol, 0.6mg/kg rocuronium bromide, 1µcg/kg fentanyl will be applied for induction, 2MAC sevoflurane + 40% air mixture for maintenance. Before ekstubation1 mg/kg tramadol iv and 15 mg/kg paracetamol iv will be administered. Paracetamol will be repeated at 8 hour intervals. Participants were extubated in the operating room after reversing residual muscle relaxation.

Postoperative Management All participants will be hospitalized min for 72 hours after surgery. Blood analyses will be done post op 24 and 48 hours. And patients will be called one week later for control. Wound healing will be observed and noted for pain, redness, edema, increased temperature. Findings will be recorded on the follow-up form.

Eligibility criteria: Inclusion Criteria:

* 40 patients
* Between 18-65
* ASA physical status I-II
* Scheduled for elective open shoulder surgery

Exclusion Criteria:

* coagulation disorders
* neuropathic disorders
* diaphragmatic paralysis
* allergy to local anesthetics
* severe cardiopulmonary disease
* psychiatric disorders
* pregnancy
* severe obesity (body mass index \>35kg/m2 )
* previous shoulder surgery
* a failed ISB
* liver failure
* kidney failure
* receiving effective treatment on immunity
* Immunosuppression
* Persons requiring intraoperative blood transfusion

Primary outcomes:
measure: interscalene block
timeFrame: 6 monthes
Secondary outcomes:
measure: general anesthesia
timeFrame: 6 monthes
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yüzüncü Yil University
state: Bardakçı
Study officials:
affiliation: Yuzuncu Yıl University
name: Arzu E Tekeli, MD
role: PRINCIPAL_INVESTIGATOR
References: