Clinical trial NCT05802979: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post Operative Pain
Keywords: mastectomy
postoperative pain
serratus anterior block
adjuvants
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: analgsic consumption
timeFrame: first 24 hours postoperative
Secondary outcomes:
measure: time to rescue analgesia
timeFrame: first 24 hours postoperative
measure: pain scores
timeFrame: first 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams University Hospitals
Study officials:
affiliation: AinShams University
name: Mohammed S Abd El Aziz, M.D.
role: STUDY_DIRECTOR
References:
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.
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
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: 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.