Breast CancerNCT07197684
Ultrasound Guided Pecs Block and Ketamine Infusion for Preventing Chronic Pain in Patients Undergoing Breast Cancer Surgery
A study testing Ketamine, Pecs block and Nalbuphine in people with Breast Cancer and Pain, Chronic, run by Aga Khan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Pain, Chronic, Post Surgical Pain
- What is being tested?
- Ketamine, Pecs block and Nalbuphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Ultrasound Guided Pecs Block With Intravenous Ketamine and Ketamine Infusion Alone For Prevention of Chronic Post-Surgical Pain in Patients Undergoing Breast Cancer Surgery: A Randomized Controlled 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
- Conditions
- Breast Cancer, Pain, Chronic, Post Surgical Pain
- Being tested
- Ketamine, Pecs block, Nalbuphine, Paracetamol
- Medical subject headings
- Breast Neoplasms, Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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 blockProcedure or surgery
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).
NalbuphineDrug
Intravenous Nalbuphine 0.1 mg/kg
ParacetamolDrug
Intravenous Paracetamol 1g or 15mg/kg (if weight is < 50kg).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). Receives: Drug: Nalbuphine; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Till six months after discharge from the hospital.
Duration of Chronic Post-Surgical Pain
From three months to six months.
Measured: Till six months after discharge from the hospital.
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).
Measured: Till six months after discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start16 Mar 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Sarfraz Siddiqui, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197684
- Sponsor's protocol ID
- 2025-11608-35490
- Other IDs
- 2025
- Status last verified
- Feb 2026
- First submitted
- 29 Aug 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Guided Pecs Block With Intravenous Ketamine and Ketamine Infusion Alone For Prevention of Chronic Post-Surgical Pain in Patients Undergoing Breast Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07197684
- Acronym / sponsor ID
- 2025-11608-35490
- Conditions
- Breast Cancer, Pain, Chronic, Post Surgical Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group K | Experimental | Drug: Ketamine, Drug: Nalbuphine, Drug: ParacetamolIntravenous 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 K+ Pecs | Experimental | Drug: Ketamine, Procedure: Pecs block, Drug: Nalbuphine, Drug: ParacetamolIntravenous 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 C | Active comparator | Drug: Nalbuphine, Drug: ParacetamolIntravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineBefore 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 | Drug | Group K, Group K+ Pecs |
| Pecs blockPecs 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). | Procedure or surgery | Group K+ Pecs |
| NalbuphineIntravenous Nalbuphine 0.1 mg/kg | Drug | Group C, Group K, Group K+ Pecs |
| ParacetamolIntravenous Paracetamol 1g or 15mg/kg (if weight is < 50kg). | Drug | Group C, Group K, Group K+ Pecs |
Primary outcome
Frequency of Chronic Post-operative Pain
Time frame: 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.
3 secondary outcomes
Character of Chronic Post-Surgical Pain
Time frame: Till six months after discharge from the hospital.
Duration of Chronic Post-Surgical Pain
Time frame: Till six months after discharge from the hospital.
Distribution of Chronic Post-Surgical Pain
Time frame: Till six months after discharge from the hospital.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine, Pecs block and Nalbuphine in people with Breast Cancer and Pain, Chronic, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Sarfraz Siddiqui (+92 34864397, sarfraz.siddiqui@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Chronic Post-operative Pain (time frame: Data will be collected from patients in the breast clinic or via telephone at one week, 1,2, 3, and 6 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.