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

Phase 3

Active, not recruiting

• Conditions: Post Operative Pain
• Interventions: Drug: Adjuvants, Anesthesia

• Registration Number: NCT05802979
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-03-26
• Last Update Submitted: 2023-03-26
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07
• Primary Completion: 2023-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Adjuvants, Anesthesia	consists of patients receiving Serratus anterior plane block using Bupivacaine + Ketamine.
group 2	Adjuvants, Anesthesia	consists of patients receiving Serratus anterior plane block using Bupivacaine + neostigmine.
group 3	Adjuvants, Anesthesia	consists of patients receiving Serratus anterior plane block using Bupivacaine + normal saline.

Primary Outcome Measures

Name	Time	Method
analgsic consumption	first 24 hours postoperative	total amount of consumed nalbuphine

Secondary Outcome Measures

Name	Time	Method
time to rescue analgesia	first 24 hours postoperative	first time to request rescue analgesia
pain scores	first 24 hours postoperative	pain scores measured by numerical pain score chart

Trial Locations

Locations (1)

AinShams University Hospitals; 🇪🇬 Cairo, Egypt