Neostigmine and Dexamethasone in Adductor Canal Block

NCT04565301 | Completed

• 1 other identifier: MS-161-2020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To compare between the efficacy of neostigmine and dexamethasone as an adjuvant to bupivacaine in adductor canal block after knee arthroscopy surgery.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• first rescue analgesia time

  Time (in hours) of first rescue analgesia (morphine) requirement for each group in the first 24 hours following the adductor canal block

  24 hours

Secondary Outcomes (4)

• morphine consumption

  24 hours

• Visual analogue scale

  up to 24 hours

• sensory block

  up to 24 hours

• Presence of Nausea and vomiting

  24 hours

Study Arms (3)

Group C

PLACEBO COMPARATOR

The patients in this group will be administered 2 ml isotonic saline + 20 ml bupivacaine 0.50 % in the adductor canal block (control group).

Other: NaCl solutions

Group D

ACTIVE COMPARATOR

The patients in this group will be administered 8 mg dexamethasone (2 ml) (23) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.

Drug: Dexamethasone

Group N

ACTIVE COMPARATOR

The patients in this group will be administered 500 mcg neostigmine (1 ml) + 1 ml isotonic saline (22) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.

Drug: neostigmine

Interventions

Dexamethasone DRUG

adductor canal block

Also known as: Decadron

Group D

neostigmine DRUG

adductor canal block

Also known as: prostigmin

Group N

NaCl solutions OTHER

adductor canal block

Also known as: normal saline

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing knee arthroscopy surgery.
• Age between 18 years and 65 years.
• Both sexes
• ASA I \& ASA II

You may not qualify if:

• Patients' refusal
• Allergy to any drug that will be used in the study
• Psychological or mental disorders.
• Disturbance of Conscious level.
• Uncooperative patients
• Coagulopathy
• Contraindications to spinal anaesthesia (e.g.: severe mitral stenosis)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy hospitals

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Calcium Dobesilate; Neostigmine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Onium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Heba Omar

  associate professor of anesthesia and surgical ICU, faculty of medicine, Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia, pain management & surgical ICU

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 25, 2020
• Study Start: June 20, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)