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RecruitingNCT06082206Updated Jul 6, 2026

Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Breast Cancer Surgery

An interventional study of thoracic paravertebral block (TPVB) and PECS group in Paravertebral Block, Pectoral Nerve Block and Chronic Pain, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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.

Read the detailed description

General anesthesia with postoperative NSAI D and opioids is a commonly used technique for postoperative analgesia after breast surgeries. Patients with mastectomy under general anesthesia commonly have pain in the axilla and upper limb that increases hospital stay, costs, and postoperative complications .Thoracic paravertebral block can be performed for analgesia after breast surgery. Ultrasound usage gave an accurate reading of the depth to the paravertebral space and can be used during the whole technique. Breast surgery is usually done with axillary dissection and can be done at single or multiple levels of thoracic paravertebral blocks .Thoracic paravertebral block is associated with multiple complications such as hypotension, pneumothorax, sympathetic block, central spread of local anesthesia or failed block which may cause limitations in the technique. The use of ultrasound in anesthesia increases the success rate of the block and decreases the incidence of variable complications .On the other hand, many interfascial plane blocks have been described. Pectoral nerve block (PECS) has been described as interfascial plane blocks and provide analgesic adjuvants for breast surgery with or without axillary dissection. The block was described as an injection of local anesthetic between the pectoralis major and minor muscles (PEC I) and between pectoralis minor and serratus anterior muscle (PEC 2) .

02

Conditions studied

  • Paravertebral Block
  • Pectoral Nerve Block
  • Chronic Pain
  • Mastectomy; Lymphedema
03

In context

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

This study's planned enrollment of 90 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • I, II, or III female patients in the age group of 20-65 years
  • with (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

Exclusion criteria

Exclusion Criteria:

  • male sex; patient refusal,
  • a less than 2 yr;
  • active malignant disease; pregnant or breastfeeding women;
  • bilateral surgery; ipsilateral breast surgery in the past 3 yr;
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    TPVB Group

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

    Procedure: thoracic paravertebral block (TPVB)

  • Experimental
    PECS Group

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

    Procedure: PECS group

Interventions

  • Procedurethoracic paravertebral block (TPVB)

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

  • ProcedurePECS group

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

06

What researchers measure

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.

    Time frame: 3 and 6 months

07

Study locations

1 of 1 sites recruiting
  • Assiut governorate
    Asyut, 715715, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25376971 ↗
  • 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. PubMed 22939099 ↗
  • 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. PubMed 25214832 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Aug 2026, 33 months after the start.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 33 months is above that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2023
First posted
Oct 13, 2023
StartActual
Nov 15, 2023
Primary completionEst.
Aug 2026
CompletionEst.
Aug 2026
Last update
Jul 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06082206
Lead sponsor
Assiut University
Responsible party
Ghada Mohammed AboelFadl (Principal investigator, Assiut University) — Principal investigator
First posted
Oct 13, 2023
Start date
Nov 15, 2023
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Jul 6, 2026

Study contacts

Ghada Abo Elfadl
Contact
ghadafadl77@gmail.com
01005802086

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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