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Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Block

Primary Purpose

Post Operative Pain

Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Adjuvants, Anesthesia
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring mastectomy, postoperative pain, serratus anterior block, adjuvants

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: ASA II patients, BMI< 35Kg/m2 Exclusion Criteria: refusal of participation, ASA III or above, history of allergy to the study drugs, BMI> 35kg/m2, coagulation disorders, psychiatric illnesses that may interfere with pain evaluation, epileptic patients, patients with tachy or brady arrthymias, patients with increased intracranial tension

Sites / Locations

  • AinShams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

group 1

group 2

group 3

Arm Description

consists of patients receiving Serratus anterior plane block using Bupivacaine + Ketamine.

consists of patients receiving Serratus anterior plane block using Bupivacaine + neostigmine.

consists of patients receiving Serratus anterior plane block using Bupivacaine + normal saline.

Outcomes

Primary Outcome Measures

analgsic consumption
total amount of consumed nalbuphine

Secondary Outcome Measures

time to rescue analgesia
first time to request rescue analgesia
pain scores
pain scores measured by numerical pain score chart

Full Information

First Posted
March 26, 2023
Last Updated
March 26, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05802979
Brief Title
Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Block
Official Title
Analgesic Efficacy of Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Plane Block in Modified Radical Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to investigate the analgesic efficacy of ketamine compared to neostigmine as adjuvants to LA in ultrasound guided Serratus Anterior Plane Block (SAPB) in patients undergoing Modified Radical Mastectomy. We hypothesize that adding either neostigmine or ketamine to bupivacaine in ultrasound guided SAPB would increase the total analgesic duration and decrease the total 24 hr postoperative Nalbuphine consumption compared to SAPB with bupivacaine only. The first 24 hr of postoperative Nalbuphine consumption is set as the primary outcome. The time of the first request of analgesia, pain score, side effects of drugs and patient hemodynamics are set as the secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
mastectomy, postoperative pain, serratus anterior block, adjuvants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Active Comparator
Arm Description
consists of patients receiving Serratus anterior plane block using Bupivacaine + Ketamine.
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
consists of patients receiving Serratus anterior plane block using Bupivacaine + neostigmine.
Arm Title
group 3
Arm Type
Placebo Comparator
Arm Description
consists of patients receiving Serratus anterior plane block using Bupivacaine + normal saline.
Intervention Type
Drug
Intervention Name(s)
Adjuvants, Anesthesia
Intervention Description
testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries
Primary Outcome Measure Information:
Title
analgsic consumption
Description
total amount of consumed nalbuphine
Time Frame
first 24 hours postoperative
Secondary Outcome Measure Information:
Title
time to rescue analgesia
Description
first time to request rescue analgesia
Time Frame
first 24 hours postoperative
Title
pain scores
Description
pain scores measured by numerical pain score chart
Time Frame
first 24 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
biologically female patients undergoing mastectomy for breast cancer
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA II patients, BMI< 35Kg/m2 Exclusion Criteria: refusal of participation, ASA III or above, history of allergy to the study drugs, BMI> 35kg/m2, coagulation disorders, psychiatric illnesses that may interfere with pain evaluation, epileptic patients, patients with tachy or brady arrthymias, patients with increased intracranial tension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed S Abd El Aziz, M.D.
Organizational Affiliation
AinShams University
Official's Role
Study Director
Facility Information:
Facility Name
AinShams University Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Abdelhamid BM, Samy S, Abdalla A, Saad A, Ollaek M, Ahmed A. Ketamine versus neostigmine as adjuvants to bupivacaine during ultrasound-guided serratus anterior plane block in modified radical mastectomy. A randomized controlled trial. Egyptian Journal of Anaesthesia. 2021; 37(1):356-363.
Results Reference
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Citation
Elbahrawy K, El-Deeb A. The effects of adding neostigmine to supraclavicular brachial plexus block for postoperative analgesia in chronic renal failure patients: a prospective randomized double-blinded study. Research and Opinion in Anesthesia and Intensive Care. 2016; 3(1):36-41. Omar AM, Mansour MA, Abdelwahab HH, Aboushanab OH
Results Reference
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PubMed Identifier
27746548
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.
Results Reference
background
PubMed Identifier
32944562
Citation
Rashwan DAEK, Mohammed AR, Kasem Rashwan SA, Abd El Basset AS, Nafady HA. Efficacy of Serratus Anterior Plane Block Using Bupivacaine/ Magnesium Sulfate Versus Bupivacaine/ Nalbuphine for Mastectomy: A Randomized, Double-Blinded Comparative Study. Anesth Pain Med. 2020 Jun 22;10(3):e103141. doi: 10.5812/aapm.103141. eCollection 2020 Jun.
Results Reference
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Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Block

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