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

NCT05802979 | Unknown Phase 3 DMC

• 1 other identifier: FMASU MD 209/2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

mastectomy; postoperative pain; serratus anterior block; adjuvants

Outcome Measures

Primary Outcomes (1)

• analgsic consumption

  total amount of consumed nalbuphine

  first 24 hours postoperative

Secondary Outcomes (2)

• time to rescue analgesia

  first 24 hours postoperative

• pain scores

  first 24 hours postoperative

Study Arms (3)

group 1

ACTIVE COMPARATOR

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

Drug: Adjuvants, Anesthesia

group 2

ACTIVE COMPARATOR

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

Drug: Adjuvants, Anesthesia

group 3

PLACEBO COMPARATOR

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

Drug: Adjuvants, Anesthesia

Interventions

Adjuvants, Anesthesia DRUG

testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries

group 1; group 2; group 3

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: biologically female patients undergoing mastectomy for breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II patients, BMI\< 35Kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams University Hospitals

Cairo, Egypt

Location

Related 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27746548 BACKGROUND

• 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.

  PMID: 32944562 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Adjuvants, Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mohammed S Abd El Aziz, M.D.

  AinShams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)