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

Study Overview
=================
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.

Official Title
-----------------
Analgesic Efficacy of Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Plane Block in Modified Radical Mastectomy

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: Adjuvants, Anesthesia


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>consists of patients receiving Serratus anterior plane block using Bupivacaine + Ketamine. | Drug: Adjuvants, Anesthesia<br>* testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries<br>|
| Active Comparator: group 2<br>consists of patients receiving Serratus anterior plane block using Bupivacaine + neostigmine. | Drug: Adjuvants, Anesthesia<br>* testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries<br>|
| Placebo Comparator: group 3<br>consists of patients receiving Serratus anterior plane block using Bupivacaine + normal saline. | Drug: Adjuvants, Anesthesia<br>* testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgsic consumption | total amount of consumed nalbuphine | first 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to rescue analgesia | first time to request rescue analgesia | first 24 hours postoperative | 
| pain scores | pain scores measured by numerical pain score chart | first 24 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mastectomy, postoperative pain, serratus anterior block, adjuvants