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

NCT07197684 | Not Yet Recruiting

• 1 other identifier: 2025-11608-35490
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

Breast Cancer; Pain, Chronic; Post Surgical Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (3)

• Character of Chronic Post-Surgical Pain

  Till six months after discharge from the hospital.

• Duration of Chronic Post-Surgical Pain

  Till six months after discharge from the hospital.

• Distribution of Chronic Post-Surgical Pain

  Till six months after discharge from the hospital.

Study Arms (3)

Group K

EXPERIMENTAL

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.

Drug: Ketamine; Drug: Nalbuphine; Drug: Paracetamol

Group K+ Pecs

EXPERIMENTAL

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).

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

Group C

ACTIVE COMPARATOR

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

Drug: Nalbuphine; Drug: Paracetamol

Interventions

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

Group K; Group K+ Pecs

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).

Group K+ Pecs

Nalbuphine DRUG

Intravenous Nalbuphine 0.1 mg/kg

Group C; Group K; Group K+ Pecs

Paracetamol DRUG

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

Group C; Group K; Group K+ Pecs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain; Pain, Postoperative

Interventions

Ketamine; Nalbuphine; Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Central Study Contacts

Ali Sarfraz Siddiqui

CONTACT

+92 34864397; sarfraz.siddiqui@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 29, 2025
• Study Start: March 16, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share