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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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group 1

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

Group Type ACTIVE_COMPARATOR

Adjuvants, Anesthesia

Intervention Type DRUG

testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries

group 2

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

Group Type ACTIVE_COMPARATOR

Adjuvants, Anesthesia

Intervention Type DRUG

testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries

group 3

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

Group Type PLACEBO_COMPARATOR

Adjuvants, Anesthesia

Intervention Type DRUG

testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries

Interventions

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Adjuvants, Anesthesia

testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No