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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Group C | Active Comparator | Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Till six months after discharge from the hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali Sarfraz Siddiqui | Contact | +92 34864397 | sarfraz.siddiqui@aku.edu |
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| 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). |
|
| Nalbuphine | Drug | Intravenous Nalbuphine 0.1 mg/kg |
|
| Paracetamol | Drug | Intravenous Paracetamol 1g or 15mg/kg (if weight is < 50kg). |
|
| Duration of Chronic Post-Surgical Pain |
From three months to six months. |
| 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). | Till six months after discharge from the hospital. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D059350 | Chronic Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D009266 | Nalbuphine |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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