About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Ketamine
DrugBefore 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/SurgeryPecs 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
DrugIntravenous Nalbuphine 0.1 mg/kg
Paracetamol
DrugIntravenous Paracetamol 1g or 15mg/kg (if weight is \< 50kg).
Treatment groups
Trial outcomes
Primary outcomes
Frequency of Chronic Post-operative Pain
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
Character of Chronic Post-Surgical Pain
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
From three months to six months.
Distribution of Chronic Post-Surgical Pain
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).
Locations
Sponsors and contacts
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