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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05802979
• Other study ID #: FMASU MD 209/2022
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Adjuvants, Anesthesia
testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries

Locations

Country	Name	City	State
Egypt	AinShams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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.

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgsic consumption	total amount of consumed nalbuphine	first 24 hours postoperative
Secondary	time to rescue analgesia	first time to request rescue analgesia	first 24 hours postoperative
Secondary	pain scores	pain scores measured by numerical pain score chart	first 24 hours postoperative