To study long term benefits of Ultrasound guided Erector Spinae Plane block on pain after 3 to 6 months of breast surgery: A Randomized Controllrd Trial

To study the long term benefits of Ultrasound guided Erector Spinae Plane block on Post Mastectomy Pain Syndrome in patients undergoing breast surgery: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046523

Enrollment

130

Registered

2022-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ultrasound guided Erector Spinae Plane block: • ESP block will be performed in the operative room following standardized monitoring, including noninvasive blood pressure, electrocardiog

Eligibility

Inclusion criteria

Inclusion criteria: Age 20-65 years American Society of Anesthesiologists (ASA) physical status I-II Scheduled for elective surgery for breast cancer (unilateral surgical procedure).

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Infection of the skin at the site of the needle puncture 3. Chronic infection 4. Known allergies to any of the study drugs 5. Coagulopathy 6. Patient already receiving analgesics 7. Mentally challenged patients 8. Liver and renal dysfunction

Design outcomes

Primary

Measure	Time frame
•To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaireTimepoint: •To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire	—

Secondary

Measure	Time frame
i. 24 hours postoperative consumption of opioids ii. Intraoperative and postoperative hemodynamic changes iii. Postoperative pain assessment up to 24 hours using Numeric Pain Rating Scale score (NRS) and duration of analgesia in 24 hours iv. Incidence of nausea, vomiting, degree of sedation and any complication up to 24 hrs postoperatively v. Neutrophil-Lymphocyte ratio (NLR), Platelet lymphocyte ratio (PLR), Number of T Helper Cells, Natural Killer Cells (NKC) and Cytotoxic T Cells at baseline and after 24 hours of surgery vi. Effect on expression of monoclonal antibodies in leukocyte subsets CD45, CD3, CD4, CD8, CD19, CD16, CD56 for follow up of cancer recurrence. For this, patients will be recruited for 12 months and follow up will be done over next 6 months. Timepoint: a. 6 months follow up for post mastectomy pain syndrome b. intraoperative and postoperative for 24 hours for opioid consumption, hemodynamics, pain assessment c. patient recruitment for 12 months and follow up over next 6 months for cancer recurrence	—

Measure

Time frame

i. 24 hours postoperative consumption of opioids ii. Intraoperative and postoperative hemodynamic changes iii. Postoperative pain assessment up to 24 hours using Numeric Pain Rating Scale score (NRS) and duration of analgesia in 24 hours iv. Incidence of nausea, vomiting, degree of sedation and any complication up to 24 hrs postoperatively v. Neutrophil-Lymphocyte ratio (NLR), Platelet lymphocyte ratio (PLR), Number of T Helper Cells, Natural Killer Cells (NKC) and Cytotoxic T Cells at baseline and after 24 hours of surgery vi. Effect on expression of monoclonal antibodies in leukocyte subsets CD45, CD3, CD4, CD8, CD19, CD16, CD56 for follow up of cancer recurrence. For this, patients will be recruited for 12 months and follow up will be done over next 6 months. Timepoint: a. 6 months follow up for post mastectomy pain syndrome b. intraoperative and postoperative for 24 hours for opioid consumption, hemodynamics, pain assessment c. patient recruitment for 12 months and follow up over next 6 months for cancer recurrence

—

Countries

India

Contacts

Public ContactPOONAM GODHWAL

AIIMS, New Delhi

drnishkarshgupta@gmail.com09013310014

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026