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Status unknownNCT02641951Updated Feb 9, 2016

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

An interventional study of Stellate ganglionic block and Pecs II block in Post Mastectomy Pain Syndrome and After Breast Surgery, sponsored by Mansoura University. Status unknown. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-09.

Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
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Study 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

Read the 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

02

Conditions studied

  • Post Mastectomy Pain Syndrome
  • After Breast Surgery

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03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 6,515 interventional studies indexed under Syndrome.

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Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 182 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Placebo comparator
    Stellate ganglionic block

    Ultrasound guided stellate ganglionic block

    Other: Stellate ganglionic block

  • Active comparator
    Pecs II block

    Ultrasound guided Pecs II block

    Other: Pecs II block

Interventions

  • OtherStellate ganglionic block

    Ultrasound guided stellate ganglionic block

  • OtherPecs II block

    Ultrasound guided Pecs II block

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What researchers measure

Primary outcomes

  1. Pain scores

    100 mm- visual analog pain scale

    Time frame: for six months after the procedure

Secondary outcomes

  1. 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

    Time frame: for six months after the procedure

  2. The quality of life score

    The quality of life will be assessed using the score QOLSF 36

    Time frame: for six months after the procedure

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02641951
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Dec 30, 2015
Start date
Nov 2015
Primary completion
May 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Feb 9, 2016

Study contacts

Zenat E Mohamed, MD
study chair · Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Reem A Sharkawy, MD
study director · Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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