Breast Cancer, Pain, Chronic, Post Surgical Pain
Conditions
Brief summary
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
DRUGKetamine
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
PROCEDUREPecs 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).
DRUGNalbuphine
Intravenous Nalbuphine 0.1 mg/kg
DRUGParacetamol
Intravenous Paracetamol 1g or 15mg/kg (if weight is \< 50kg).
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Chronic Post-operative Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Character of Chronic Post-Surgical Pain | 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. |
| Duration of Chronic Post-Surgical Pain | Till six months after discharge from the hospital. | From three months to six months. |
| Distribution of Chronic Post-Surgical Pain | 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). |
Contacts
CONTACTAli Sarfraz Siddiqui
Outcome results
None listed