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

NCT ID: NCT07197684

Last Updated: 2026-02-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-16
• Study Completion Date: 2027-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group K

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: 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

Nalbuphine

Intervention Type: DRUG

Intravenous Nalbuphine 0.1 mg/kg

Paracetamol

Intervention Type: DRUG

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

Group K+ Pecs

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).

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: 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

Pecs block

Intervention Type: 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).

Nalbuphine

Intervention Type: DRUG

Intravenous Nalbuphine 0.1 mg/kg

Paracetamol

Intervention Type: DRUG

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

Group C

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

Group Type: ACTIVE_COMPARATOR

Nalbuphine

Intervention Type: DRUG

Intravenous Nalbuphine 0.1 mg/kg

Paracetamol

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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).

Intervention Type: PROCEDURE

Nalbuphine

Intravenous Nalbuphine 0.1 mg/kg

Intervention Type: DRUG

Paracetamol

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Ali Sarfraz Siddiqui

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ali Sarfraz Siddiqui

Role: CONTACT

sarfraz.siddiqui@aku.edu

+92 34864397

Other Identifiers

2025-11608-35490

Identifier Type: -

Identifier Source: org_study_id