NCT06082206

Brief Summary

Chronic pain after Mastectomy is frequent and an important healthcare priority because of its effect on quality of life. Although the association between the severity of acute pain after surgery and the likelihood of chronic pain is known, their causal relationship has not been clarified. Mastectomy, frequently done for the management of breast cancer, is associated with significant acute postoperative pain and limited shoulder movement.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

October 9, 2023

Last Update Submit

March 6, 2026

Conditions

Paravertebral BlockPectoral Nerve BlockChronic PainMastectomy; Lymphedema

Outcome Measures

Primary Outcomes (1)

  • The incidence of chronic pain

    The incidence of chronic pain, with a Douleur Neuropathique 4 (DN4) questionnaire score ≥ 4, indicating neuropathic pain.

    3 and 6 months

Study Arms (2)

TPVB Group

EXPERIMENTAL

Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.

Procedure: thoracic paravertebral block (TPVB)

PECS Group

EXPERIMENTAL

10 mL of 0.25% bupivacaine between the pectoralis major and minor muscles. and 20 mL of 0.25% bupivacaine between the pectoralis minor and serratus anterior muscles at the level of the 4th rib.

Procedure: PECS group

Interventions

thoracic paravertebral block (TPVB)PROCEDURE

Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.

TPVB Group
PECS groupPROCEDURE

entering the plane between the pectoralis minor muscle and serratus anterior muscle, and bupivacaine 0.25% 20 ml was deposited in this space

PECS Group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA grade I, II, or III female patients in the age group of 20-65 years
  • with body mass index (BMI) of 25-35 who were undergoing mastectomy with or without axillary lymph node or sentinel lymph node dissection or partial mastectomy (sparing the skin, areola, and nipple) with axillary lymph node dissection

You may not qualify if:

  • male sex; patient refusal,
  • a life expectancy less than 2 yr;
  • active malignant disease; pregnant or breastfeeding women;
  • bilateral surgery; ipsilateral breast surgery in the past 3 yr;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, 715715, Egypt

RECRUITING

Related Publications (3)

  • Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

    PMID: 25376971BACKGROUND

  • Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

    PMID: 22939099BACKGROUND

  • Simpson J, Ariyarathenam A, Dunn J, Ford P. Breast surgery using thoracic paravertebral blockade and sedation alone. Anesthesiol Res Pract. 2014;2014:127467. doi: 10.1155/2014/127467. Epub 2014 Aug 21.

    PMID: 25214832BACKGROUND

MeSH Terms

Conditions

Chronic PainLymphedema

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLymphatic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Ghada Abo Elfadl

CONTACT

01005802086ghadafadl77@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 13, 2023

Study Start

November 15, 2023

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

EG(1)