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

Ain Shams University

Status and phase: Active, not recruiting; Phase 3

Conditions: Post Operative Pain

Treatments: Drug: Adjuvants, Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05802979

FMASU MD 209/2022

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 3 patient groups, including a placebo group

group 1

Active Comparator group

Description:

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

Treatment:

Drug: Adjuvants, Anesthesia

group 2

Active Comparator group

Description:

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

Treatment:

Drug: Adjuvants, Anesthesia

group 3

Placebo Comparator group

Description:

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

Treatment:

Drug: Adjuvants, Anesthesia