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NCT Number: NCT07197684

Ultrasound Guided Pecs Block and Ketamine Infusion for Preventing Chronic Pain in Patients Undergoing Breast Cancer Surgery

The goal of this clinical trial is to is to compare the effectiveness of ultrasound-guided Pecs block with intravenous ketamine versus intravenous ketamine infusion alone in preventing Chronic Post-Surgical Pain (CPSP) in patients undergoing breast cancer surgery. The main question it aims to answer is,

How effective is the ketamine and ketamine with pecs block in reducing the frequency of Chronic Post-Surgical Pain after breast cancer surgery

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chronic Pain Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Chronic Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Surgical Pain Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult female patients with breast cancer aged between 18-75 years
  • ASA (American Society of Anesthesia) physical status I, II, and III
  • Patients scheduled for elective breast cancer surgery (Mastectomy with or without axillary clearance)

Exclusion criteria

  • Refusal to participate or withdrawal of informed consent
  • Surgical procedures involving breast reconstruction with flaps or implants
  • Patient scheduled for bilateral mastectomy
  • Reoperation on the same side due to cancer recurrence
  • Known allergy or contraindication to study drugs
  • History of severe psychiatric illness (e.g., major depression, bipolar disorder, schizophrenia)
  • Chronic opioid use, substance abuse, or opioid addiction
  • Pre-existing chronic pain or neuropathic pain disorders
  • Coagulopathy, anticoagulation therapy, or localized infection at the site of block
  • Uncontrolled hypertension and ischemic heart disease

Treatment and study plan

ketamine

Drug

Before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr.

Ketamine infusion will be stopped 30 minutes before the end of the surgery

PECS block

Procedure

Pecs block will be performed before surgical incision with the help of an ultrasound (US) by experienced anesthesiologist. The drug used for the pecs block will be two syringes of 10ml and 20 ml containing bupivacaine 0.25% (total 30 ml).

Nalbuphine

Drug

Intravenous Nalbuphine 0.1 mg/kg

Paracetamol

Drug

Intravenous Paracetamol 1g or 15mg/kg (if weight is < 50kg).

Primary outcomes

  1. Frequency of Chronic Post-operative Pain

    Time frame: Data will be collected from patients in the breast clinic or via telephone at one week, 1,2, 3, and 6 months after surgery.

    Pain intensity will be assessed using an 11-point numeric rating scale (NRS) by an investigator blinded to group allocation. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain severity and therefore a worse outcome.

    Data will be collected from patients in the breast clinic or via telephone at one week, 1,2, 3, and 6 months after surgery.

    All patients will be followed till six months after discharge from the hospital.

Secondary outcomes

  1. Character of Chronic Post-Surgical Pain

    Time frame: Till six months after discharge from the hospital.

    Patients will be asked to describe the character(quality) of their pain (e.g., burning, sharp, pricking, electric-shock-like) during follow-up visits.

    patients will be subjectively asked to describe the quality of pain.

  2. Duration of Chronic Post-Surgical Pain

    Time frame: Till six months after discharge from the hospital.

    From three months to six months.

  3. Distribution of Chronic Post-Surgical Pain

    Time frame: Till six months after discharge from the hospital.

    Patients will be asked to report the location of any persistent pain during follow-up visits. Using a standardized body map diagram, they will indicate whether pain is present at the surgical site or in surrounding areas (e.g., axilla, upper arm, upper back, chest wall).

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Sarfraz Siddiqui

CONTACT

[email protected]

+92 34864397

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

Effect of Ultrasound Guided Pecs Block With Intravenous Ketamine and Ketamine Infusion Alone For Prevention of Chronic Post-Surgical Pain in Patients Undergoing Breast Cancer Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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