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

NCT02641951 | Unknown DMC

• 1 other identifier: R/15.08.41
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Post Mastectomy Pain Syndrome; After Breast Surgery

Outcome Measures

Primary Outcomes (1)

• Pain scores

  100 mm- visual analog pain scale

  for six months after the procedure

Secondary Outcomes (2)

• The range of motion of the glenohumeral joint

  for six months after the procedure

• The quality of life score

  for six months after the procedure

Study Arms (2)

Stellate ganglionic block

PLACEBO COMPARATOR

Ultrasound guided stellate ganglionic block

Other: Stellate ganglionic block

Pecs II block

ACTIVE COMPARATOR

Ultrasound guided Pecs II block

Other: Pecs II block

Interventions

Stellate ganglionic block OTHER

Ultrasound guided stellate ganglionic block

Stellate ganglionic block

Pecs II block OTHER

Ultrasound guided Pecs II block

Pecs II block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Officials

• Zenat E Mohamed, MD

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

  STUDY CHAIR

• Reem A Sharkawy, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: December 30, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 9, 2016

Record last verified: 2016-02