Stellate Ganglionic Block Versus Stellate Ganglionic Block Plus Pecs II Block for Mastectomy Pain

After Breast Surgery Clinical Trial

Official title:

Stellate Ganglionic Block Versus Combined Stellate Ganglionic Block and Modified Pectoral Nerve Block in Treatment of Post Mastectomy Pain Syndrome.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02641951
• Other study ID #: R/15.08.41
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 24, 2015
• Last updated: February 5, 2016
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Eduacaion
• Study type: Interventional

Clinical Trial Summary

Post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy. result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy, A second version of the pectoral nerve block is described, called ''modified Pecs block'' or Pecs block type II.

This novel approach aims to block at least the pectoral nerves, the intercostobrachial, intercostals III-IV-V-VI and the long thoracic nerve. These nerves need to be blocked to provide complete analgesia during breast surgery

Description:

The aim of this study is to evaluate the efficacy of ultrasound guided stellate ganglionic block alone versus stellate ganglionic block plus pecs II block in management of chronic postmastectomy pain ,patient will be trained to use visaual analog scale to describe their pain range of movement will be assessed using manual geniometry at post procedure visits at one month ,3 months and 6 months procedures in each group will done using ultrasound guidance mixture will be used.

All patients will be informed about the procedure and its possible consequences after detailed explanation of protocol of this study. Written informed consents will be obtained before the procedure.

With each block, an intravenous cannula will be inserted and secured. All suitable resuscitation equipment and drugs will be available. Vital signs (heart rate, blood pressure, and oxygen saturation) will be monitored throughout the procedure and up to 1 hour after the block performance. Midazolam 0.02 ug/kg will be administered intravenously as premedication.

Brief evaluation will be done for all patients with regard to their systemic diseases, general condition, and coagulation status.

All patients will be familiar with the use of 10-cm visual analogue scale score (VAS) identifying 0 as no pain and 10 as worst imaginable pain.Basal assessment of range of movement for abduction ,external rotation ,and forward flextion using manual geniometry and patients will be asked to complete Quality of life questionnaire

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status III or IV.

• Patients having irradiating pain of anterior chest wall and axilla after breast surgery.

• Patients having irradiating pain of ipsilateral arm after breast surgery

• Pain not responding to conservative treatment

• Pain persisting for more than 3 month

Exclusion Criteria:

• Local skin infection

• Coagulation or blood disease

• Pregnancy

• Postpartum or lactating females

• Allergy to the study medications.

• Severely altered consciousness level.

• Psychiatric disorder

• Drug abuse

• Spine or chest wall deformities

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• After Breast Surgery
• Post Mastectomy Pain Syndrome

Intervention

Other:
• Stellate ganglionic block
Ultrasound guided stellate ganglionic block
• Pecs II block
Ultrasound guided Pecs II block

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	100 mm- visual analog pain scale	for six months after the procedure	No
Secondary	The range of motion of the glenohumeral joint	Improvements in the range of motion of the glenohumeral joint, which included forward extension and external rotation will be recorded using scoring system score 0 to 9 for some movements range and 0 to 160 for others	for six months after the procedure	No
Secondary	The quality of life score	The quality of life will be assessed using the score QOLSF 36	for six months after the procedure	No