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Not yet recruiting NCT07197684

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

No phase Interventional Breast Cancer Pain, Chronic Post Surgical Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketamine, Pecs block, Nalbuphine, Paracetamol.
Who it may be relevant to
Registry conditions: Breast Cancer, Pain, Chronic, Post Surgical Pain. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

Interventions

  • Drug Ketamine
    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
  • Procedure Pecs block
    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).
  • Drug Nalbuphine
    Intravenous Nalbuphine 0.1 mg/kg
  • Drug Paracetamol
    Intravenous Paracetamol 1g or 15mg/kg (if weight is \< 50kg).

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • Character of Chronic Post-Surgical Pain [Time frame: Till six months after discharge from the hospital.]
  • Duration of Chronic Post-Surgical Pain [Time frame: Till six months after discharge from the hospital.]
  • Distribution of Chronic Post-Surgical Pain [Time frame: Till six months after discharge from the hospital.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07197684 · 2025-11608-35490

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗