NCT04544228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

August 28, 2020

Last Update Submit

March 1, 2021

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Time of first request of analgesia

    it will be calculated from the time of complete injection of local anesthetics till the numerical rating scale (NRS) is ≥3.

    24 hours postoperative

Secondary Outcomes (3)

  • The total amount of morphine consumption

    24 hours postoperative

  • Total amount of intraoperative fentanyl.

    2 hours

  • Numeric Pain Rating Scale

    24 hours

Study Arms (3)

ketamine

EXPERIMENTAL

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

Procedure: Serratus Anterior Plane Block TechniqueProcedure: General anesthesiaDrug: bupivacaine +ketamine

Neostigmine

EXPERIMENTAL

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

Procedure: Serratus Anterior Plane Block TechniqueProcedure: General anesthesiaDrug: bupivacaine + neostigmine

Control

ACTIVE COMPARATOR

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

Procedure: Serratus Anterior Plane Block TechniqueProcedure: General anesthesiaDrug: bupivacaine +saline

Interventions

Serratus Anterior Plane Block TechniquePROCEDURE

The patient will be placed in Lateral Decubitus with a surgical side upwards with arm abduction. A linear ultrasound transducer (6-13 MHz) will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge regional block needle will be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. The expecting depth for this block is 1-4 cm. After aspiration, injection 30ml local anesthetic mixture will be injected anteriorly to the rib and deep to the serratus anterior muscle.

ControlNeostigmineketamine
General anesthesiaPROCEDURE

Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium. Anaesthesia will be maintained with inhaled sevoflurane 2-2.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 m\\kg will be provided every 30 minutes. The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.

ControlNeostigmineketamine
bupivacaine +ketamineDRUG

30 ml bupivacaine 0.25% + 1 ml ketamine (50mg) in Serratus Anterior Plane Block.

Also known as: ketamine
ketamine
bupivacaine + neostigmineDRUG

30 ml bupivacaine 0.25% + 1 ml neostigmine (500 μg)in Serratus Anterior Plane Block.

Also known as: neostigmine
Neostigmine
bupivacaine +salineDRUG

30 ml bupivacaine 0.25% + 1 ml normal saline in Serratus Anterior Plane Block.

Also known as: saline
Control

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ● 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.

You may not qualify if:

  • ● 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine-Cairo University

Cairo, 1772, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 29720754BACKGROUND

  • 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.

    PMID: 27746548BACKGROUND

  • 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.

    PMID: 23923989BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, GeneralKetamineBupivacaineNeostigmineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnilidesAmidesAniline CompoundsAminesPhenylammonium CompoundsQuaternary Ammonium CompoundsOnium CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Bassant abdelhamid, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 10, 2020

Study Start

September 5, 2020

Primary Completion

February 20, 2021

Study Completion

March 1, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations

EG(1)