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

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

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

Study Overview

• Status: Unknown
• Conditions: Post Mastectomy Pain Syndrome; After Breast Surgery
• Intervention / Treatment: Other: Stellate ganglionic block; Other: Pecs II block

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Stellate ganglionic block; Ultrasound guided stellate ganglionic block	Other: Stellate ganglionic block; Ultrasound guided stellate ganglionic block
Active Comparator: Pecs II block; Ultrasound guided Pecs II block	Other: Pecs II block; Ultrasound guided Pecs II block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	100 mm- visual analog pain scale	for six months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The quality of life score	The quality of life will be assessed using the score QOLSF 36	for six months after the procedure

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Zenat E Mohamed, MD, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt; Study Director: Reem A Sharkawy, MD, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 5, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: R/15.08.41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided