Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy

Cairo University (CU)

Status: Completed

Conditions: Postoperative Pain

Treatments: Procedure: Serratus Anterior Plane Block Technique; Drug: bupivacaine +saline; Drug: bupivacaine +ketamine; Procedure: General anesthesia; Drug: bupivacaine + neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT04544228

MS-101-2020

Details and patient eligibility

About

The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.

Full description

Breast cancer is the most common malignancy among females with incidence of 18,660 patients each year in Egypt. Modified Radical Mastectomy is considered the main surgical management for breast cancer accounting for 31% of all breast surgery cases.

Ultrasound guided Serratus anterior plane block provides analgesia for breast and lateral thoracic wall surgeries by blocking nerves that are located in a compartment between the serratus anterior and the latissimus dorsi muscles ( the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve and thoracodorsal nerve).

A previous study demonstrated the analgesic efficacy of ketamine in patients undergoing modified pectoral nerve block in breast cancer surgery as evidenced by prolonged time to first rescue analgesia and reduced total opioid consumption.

Neostigmine has been used as an additive to local anesthetics to prolong the analgesic effect. Although there is good evidence for a spinal action of neostigmine, its analgesic efficacy as an adjuvant to local anesthetic is still unclear.

The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ● Female patients

  • Type of surgery; Modified Radical Mastectomy (MRM).
  • Physical status ASA II, III.
  • Age ≥ 21 and ≤ 65 Years.
  • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Exclusion criteria

• ● Patients with Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).

  • History of psychological disorders and/or chronic pain.
  • Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
  • Infection of the skin at the site of needle puncture area
  • Patient refusal.
  • Severe respiratory or cardiac disorders.
  • Advanced liver or kidney disease.
  • Pregnancy.
  • Patient with surgery duration more than two hours

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

ketamine

Experimental group

Description:

Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine

Treatment:

Drug: bupivacaine +ketamine

Procedure: Serratus Anterior Plane Block Technique

Procedure: General anesthesia

Neostigmine

Experimental group

Description:

Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine

Treatment:

Drug: bupivacaine + neostigmine

Procedure: Serratus Anterior Plane Block Technique

Procedure: General anesthesia

Control

Active Comparator group

Description:

Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline.

Treatment:

Procedure: Serratus Anterior Plane Block Technique

Drug: bupivacaine +saline

Procedure: General anesthesia