20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis

Study tools:

1. After approval of study protocol, patients will be enrolled into the study according to inclusion and exclusion criteria.

2. A total of 50 patients will be categorized into 2 groups:

   • Group A "Stellate Ganglion Block 20% alcohol with steroid local anesthetic technique
   • Group B " Stellate Ganglion Block steroid local anesthetic technique only
3. Patients will give their consent after having been fully informed about the more frequent side effects of each procedure, such as compensatory sweating and especially those after the block : interscapular pain, transient pneumothorax, and Horner's syndrome.

4. Objective Sweating Assessment:

   • Patients transferred from dermatology clinic after Diagnosis with primary hyperhidrosis and failed topical treatement.
   • asses severity of sweating by HDSS.

5. Stellate Ganglion Block 20% alcohol with steroid local anesthetic technique

   • The patient will be placed in the supine position on the operating table.
   • Routine monitoring: pulse oximetet, ABP&ECG
   • IV canula
   • patient will sedate befoer starring the procedure By "midathetic +fentanyl"
   • support the patient with oxygen By nasal canula sterilized drape will be used to ensure safety. The needle tip will be placed in the stellate ganglion under ultrasound guidance "high frequency linear probe" EG LOGIQ L6-12-RS" Alcohol 20% 2ml, lidocaine" 2% 3ml, Dexamethasone amp 8mg 2ml and 3ml normal saline will be used for Stellate Ganglion Block. inject a total of 10 mL of the mixture.

   Follow up Signs of success of the block as drop of eye lid, redness eye and flushing of half side of the face Follow up hotness and dryness of hand after 1 hour of injection . Follow up after 1 week, injection may be repeated If dryness disappear.

6. Stellate Ganglion Block steroid local anesthetic technique only

   • The patient will be placed in the supine position on the operating table.
   • Routine monitoring: pulse oximetet, ABP&ECG
   • IV canula
   • patient will sedate befoer starring the procedure By "midathetic +fentanyl"
   • support the patient with oxygen By nasal canula
   • sterilized drape will be used to ensure safety.
   • The needle tip will be placed in the stellate ganglion under ultrasound guidance "high frequency linear probe" EG LOGIQ L6-12-RS"
   • xylocaine" lidocaine" 2% 3ml, dexamethasone amp 2ml and 5ml normal saline with total of 10ml will be used for Stellate Ganglion Block.
   • Follow up Signs of success of the block as drop of eye lid, redness eye and flushing of half side of the face
   • Follow up hotness and dryness of hand after 1 hour of injection .
   • Follow up after 1 week, injection may be repeated If dryness disappear.

7. Follow-Up

   Follow-up will include periodical outpatient visits during which all evaluations will be repeated. Owing to rapid response, forefinger temperature will also be determined 1 hour after treatment.

   Follow up for 6 months

8. Assessment:

   • Presence/absence of hyperhidrosis: Hyperhidrosis Disease Severity scale " HDSS "will be used, involving asking the patients to describe their sweating status before and after treatment.

A score of 1 or 2 will be classified as mild or moderate hyperhidrosis. A score of 3 or 4 will be classified as severe hyper-hidrosis. A 1-point decrease in the patient's sweating scale means a 50% decrease in sweat production, and a 2-point decrease means an 80% decrease in sweat production, a 3-point decrease means about an 90% decrease in sweat production (Solish et al., 2007).

• Compensatory hyperhidrosis events:classified as no compensatory hyperhidrosis, Mild (i.e., sometimes sweaty and sometimes not sweaty), Moderate (i.e., constantly aware but not troublesome or troublesome but controlled by clothing), and Severe (i.e., causing embarrassment or regret over having undergone endoscopic thoracic sympathectomy) (Purtuloglu et al., 2013).
• Other outcomes will include patient satisfaction (satisfied or not satisfied), preoperative, intraoperative, and postoperative evaluation of measured hemodynamic parameters, and other complications (i.e., pneumothorax, hematoma, ptosis, muscle weakness, and muscle spasm).
• A cost comparison between groups concerning devices, drugs, global time in operating room, medical personnel, and hospital stay will also be carried out.

Study outcomes:

• Primary outcome: hyperhydrosis severity scale i.e. presence/absence of hyperhidrosis.

• Secondary outcome parameters:

  • Compensatory hyperhidrosis events,
  • Patient satisfaction (satisfied or not satisfied),

  • Preoperative, intraoperative, and postoperative evaluation of measured hemodynamic parameters.

    . Number of injection needed to overcome hyperhydrosis.

  • Complications (i.e., pneumothorax, hematoma, ptosis, muscle weakness, and muscle spasm).
  • Cost.
  • Time in operating room.
  • Hospital stay.

Ethical Consideration:

Participating patients will sign informed written consent after thorough explanation of the details and purpose of the current study.

Patients have the right to withdraw from the study at any phase without being adversely impacted regarding the medical care they should receive.

The study protocol will be approved by the Ethical Research Committee of Anesthesia Department and Faculty of Medicine, Fayoum University.

Confidentiality of data will be maintained by the following:

• Substitution of codes for information that identifies the participant (e.g., using numbers instead of names to identify participants).
• Removal of face sheets that contain identifiers, such as names.
• Files containing electronic data will be password-protected and encrypted (at least when data were transferred or transported) and closed when computers will be left unattended.
• Limited access to all data that identifies participants.
• Paper records will be stored in locked cabinets.
• Consents will be stored securely in locked cabinets, separately from the research data.
• Proper disposal of all paper documents that contain identifiers .Statistical analysis and statistical package:

Data will screen, for normality assumption test and homogeneity of variance, normality test of data using Kolmogorov Smirnov test will use, that reflect the data is normally distributed or non-normally distributed after removal outliers that detect by box and whiskers plots. All these findings will allow conducting parametric or non-parametric analysis. The statistical analysis will conduct by using statistical SPSS Package program version 25 for Windows (SPSS, Inc., Chicago, IL). The following statistical procedures will perform for:

1. Parametric data will express as the mean and standard deviation (SD) for major variables. Independent (unpaired) t-test will use to compare between both groups (misoprostol group vs. lidocaine spray group) for major outcome variables.
2. Non-parametric data will express as the median and interquartile range (IQR) for major variables. Mann-Whitney U test will use to compare between both groups (misoprostol group vs. lidocaine spray group) for major outcome variables.
3. Statistical level all statistical analyses for parametric and non-parametric data are significant at level of probability less than an equal 0.05 (P ≤ 0.05).