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

Aga Khan University

Status: Not yet enrolling

Conditions: Breast Cancer; Post Surgical Pain; Pain, Chronic

Treatments: Drug: Nalbuphine; Drug: Paracetamol; Drug: Ketamine; Procedure: Pecs block

Study type: Interventional

Funder types: Other

Identifiers

NCT07197684

2025-11608-35490

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 3 patient groups

Group K

Experimental group

Description:

Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is \< 50kg). Additionally, before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr (11) will be administered. Ketamine infusion will be stopped 30 minutes before the end of the surgery.

Treatment:

Drug: Ketamine

Drug: Paracetamol

Drug: Nalbuphine

Group K+ Pecs

Experimental group

Description:

Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is \< 50kg). Additionally, before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr (11) will be administered. Ketamine infusion will be stopped 30 minutes before the end of the surgery. Additionally, 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).

Treatment:

Procedure: Pecs block

Drug: Ketamine

Drug: Paracetamol

Drug: Nalbuphine

Group C

Active Comparator group

Description:

Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is \< 50kg).

Treatment:

Drug: Paracetamol

Drug: Nalbuphine