Clinical trial NCT04544228: Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
Official title: Comparison of Effectiveness of Adding Ketamine or Neostigmine to Bupivacaine for Ultrasound Guided Serratus Anterior Plane Block in Modified Radical Mastectomy , Randomized Double Blinded Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of first request of analgesia
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: The total amount of morphine consumption
timeFrame: 24 hours postoperative
measure: Total amount of intraoperative fentanyl.
timeFrame: 2 hours
measure: Numeric Pain Rating Scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine-Cairo University
Study officials:
affiliation: Cairo University
name: Bassant abdelhamid, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Mourad MB, Amer AF. Effects of adding dexamethasone or ketamine to bupivacaine for ultrasound-guided thoracic paravertebral block in patients undergoing modified radical mastectomy: A prospective randomized controlled study. Indian J Anaesth. 2018 Apr;62(4):285-291. doi: 10.4103/ija.IJA_791_17.
citation: Pandey V, Mohindra BK, Sodhi GS. Comparative evaluation of different doses of intrathecal neostigmine as an adjuvant to bupivacaine for postoperative analgesia. Anesth Essays Res. 2016 Sep-Dec;10(3):538-545. doi: 10.4103/0259-1162.180779.
citation: Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.