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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorAga Khan University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Pecs block

    Procedure/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).

  • Nalbuphine

    Drug

    Intravenous Nalbuphine 0.1 mg/kg

  • Paracetamol

    Drug

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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Group KExperimental treatment 3 interventions
Group B: Group K+ PecsExperimental treatment 4 interventions
Group C: Group CActive comparator 2 interventions

Trial outcomes

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.

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.

Secondary outcomes

1

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.

Time frame
Till six months after discharge from the hospital.
2

Duration of Chronic Post-Surgical Pain

From three months to six months.

Time frame
Till six months after discharge from the hospital.
3

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).

Time frame
Till six months after discharge from the hospital.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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