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

NCT ID: NCT02641951

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-07-31

Brief 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

Detailed 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

Conditions

Post Mastectomy Pain Syndrome; After Breast Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Stellate ganglionic block

Ultrasound guided stellate ganglionic block

Group Type: PLACEBO_COMPARATOR

Stellate ganglionic block

Intervention Type: OTHER

Ultrasound guided stellate ganglionic block

Pecs II block

Ultrasound guided Pecs II block

Group Type: ACTIVE_COMPARATOR

Pecs II block

Intervention Type: OTHER

Ultrasound guided Pecs II block

Interventions

Stellate ganglionic block

Ultrasound guided stellate ganglionic block

Intervention Type: OTHER

Pecs II block

Ultrasound guided Pecs II block

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zenat E Mohamed, MD

Role: STUDY_CHAIR

Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Reem A Sharkawy, MD

Role: STUDY_DIRECTOR

Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Other Identifiers

R/15.08.41

Identifier Type: -

Identifier Source: org_study_id