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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03212443
Other study ID # Diskapi4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 10, 2017
Est. completion date March 22, 2018

Study information

Verified date August 2018
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve block adding to general anesthesia might improve the quality of postoperative analgesia. The aim of the study is to compare the subacromial local anesthetic infiltration and the suprascapular-axillary nerve blocks combination for intraoperative sevoflurane consumption, postoperative analgesia and analgesic consumption.


Description:

After informed consent and with ethics approval, 60 ASA 2-3 patients scheduled for elective arthroscopic shoulder surgery will be included in this study. Patient will be divided to two groups by using computer -generated list for randomization. In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure. In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia. In all patients after standard and BIS (Bi spectral index) monitorization general anesthesia will be induced with remifentanil (10mcg iv), propofol (2.5 mg/kg iv) and rocuronium (0.5mg/kg iv). After intubation, anesthesia will be maintained with 50% O2 and N2O mixture. Hemodynamic parameters, BIS values, end-tidal sevoflurane consumption will be recorded by blind investigator. Postoperative visual analog scale (VAS) values, postoperative analgesic consumption (Tramadol, patient controlled analgesia), complications will be recorded.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date March 22, 2018
Est. primary completion date February 25, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- American society of anesthesia physical status (ASA) 1,2 patients

- Elective arthroscopic shoulder surgery

Exclusion Criteria:

- ASA 3,4 patients

- Coagulation abnormality

- Body mass index >30

- Preexisting neurological deficit Local anesthetic allergy history Diabetes

Study Design


Intervention

Procedure:
Suprascapular nerve- axillary nerve block combination
In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia
Subacromial infiltration
In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure

Locations

Country Name City State
Turkey Derya Ozkan Ankara

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct; — View Citation

Ritchie ED, Tong D, Chung F, Norris AM, Miniaci A, Vairavanathan SD. Suprascapular nerve block for postoperative pain relief in arthroscopic shoulder surgery: a new modality? Anesth Analg. 1997 Jun;84(6):1306-12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Bleeding assesment stage1: Good surgical visualization (numeric rating scale 7<), Stage 2: Moderate bleeding (numeric rating sacle =4-7), Stage 3: Severe bleeding, bad surgical visualization (numeric rating scale < 4) 5th, 10th,20th,30th,40th,50th minutes after induction of anesthesia
Primary Postoperative VAS scores Ranging from 0: no pain to 10: worst pain Through postoperative period, an avarage of 30 minutes
Secondary sevoflurane consumption End tidal sevoflurane concentration values assesment during the surgery 5th, 10th,20th,30th,40th,50th minutes after induction of anesthesia
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