Comparison of three nerve block techniques on postoperative pain and recovery after modified radical mastectomy
| ISRCTN | ISRCTN17247698 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17247698 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Afyonkarahisar Health Sciences University (Afyonkarahisar Sağlık Bilimleri Üniversitesi) |
| Funder | Investigator initiated and funded |
- Submission date
- 06/11/2025
- Registration date
- 07/11/2025
- Last edited
- 07/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
A modified radical mastectomy is a procedure in which the entire breast is removed, including the skin, areola, nipple, and most axillary lymph nodes. It often causes significant postoperative pain that may delay recovery. This study compares three regional anesthesia techniques — erector spinae plane block (ESPB), thoracic paravertebral block (TPVB), and pectoral nerve block (PECS) — to determine which provides better pain relief and improves quality of recovery.
Who can participate?
Adult female patients aged 18–70 years, with ASA physical status I–II, scheduled for unilateral modified radical mastectomy. Patients with obesity, previous breast surgery, coagulation disorders, allergies to study drugs, severe systemic diseases or opioid use were excluded.
What does the study involve?
Participants were randomly allocated to receive ESPB, TPVB, or PECS block before general anesthesia. All patients received the same surgical and anesthetic treatment. Pain scores, morphine use, side effects, and quality of recovery were assessed over 24 hours after surgery.
What are the possible benefits and risks of participating?
Participants may experience improved pain control and comfort. Risks are minimal and limited to those associated with standard regional anesthesia techniques (e.g., bleeding, infection, block failure).
Where is the study run from?
Afyonkarahisar Health Sciences University (Türkiye)
When is the study starting and how long is it expected to run for?
February 2021 to March 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Bilal Atilla Bezen, drbilalatilla@gmail.com
Contact information
Public, Scientific, Principal investigator
Afyonkarahisar Sağlık Bilimleri Üniversitesi
TIP FAKÜLTESİ
Zafer Sağlık Külliyesi A Blok, Dörtyol Mah. 2078 Sok. No:3
Afyonkarahisar
03030
Türkiye
 ORCID ID |
0000-0002-3435-9690 |
|---|---|
| Phone | +90 (0)5419671370 |
| drbilalatilla@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre prospective randomized controlled single-blind clinical trial with parallel group assignment |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomized controlled trial comparing the effects of erector spinae plane block, thoracic paravertebral block, and pectoral nerve block on postoperative analgesia and Quality of Recovery-15 in patients undergoing modified radical mastectomy |
| Study objectives | Primary Objective: To compare the effects of erector spinae plane block (ESPB), thoracic paravertebral block (TPVB), and pectoral nerve block (PECS) on postoperative opioid consumption in patients undergoing modified radical mastectomy. Secondary Objectives: To compare time to first analgesic request, QoR-15 scores, pain scores, side effects, and patient satisfaction between the three block techniques. |
| Ethics approval(s) |
Approved 30/04/2021, Afyonkarahisar Health Sciences University Clinical Research Ethics Committee (Afyonkarahisar Sağlık Bilimleri Üniversitesi | TIP FAKÜLTESİ | Zafer Sağlık Külliyesi A Blok, Dörtyol Mah. 2078 Sok. No:3, Afyonkarahisar, 03030, Türkiye; +90 (0)272 246 33 01; info@afsu.edu.tr), ref: 335 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | A computer-generated randomization sequence was used for participant allocation into three intervention groups (ESPB, TPVB, and PECS), and group assignments were concealed using sealed opaque envelopes. All groups received the same standardized general anesthesia protocol, serving as the control framework for comparison between the different regional techniques. After the operation, the patient's medical follow-up and treatment were performed by a researcher blinded to the study. |
| Intervention type | Other |
| Primary outcome measure(s) |
Total morphine consumption (mg) measured using the patient-controlled analgesia (PCA) device at 24 hours postoperatively |
| Key secondary outcome measure(s) |
1. Time to first morphine request, recorded from arrival in recovery until the first PCA morphine dose request (minutes) |
| Completion date | 23/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target sample size at registration | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | 1. American Society of Anesthesiologists (ASA) physical status I–II 2. Scheduled for unilateral modified radical mastectomy |
| Key exclusion criteria | 1. Obesity 2. Previous breast surgery 3. Bleeding disorders 4. Allergies to study drugs 5. Anticoagulant or chronic analgesic use 6. Severe cardiac, hepatic, or renal disease |
| Date of first enrolment | 15/05/2021 |
| Date of final enrolment | 22/03/2023 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Zafer Sağlık Külliyesi A Blok, Dörtyol Mah. 2078 Sok. No:3
Afyonkarahisar
03030
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Due to institutional and national legal restrictions, individual participant data cannot be shared. |
Editorial Notes
07/11/2025: Study's existence confirmed by the Afyonkarahisar Health Sciences University Clinical Research Ethics Committee.
