Neostigmine and Dexamethasone in Adductor Canal Block

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ClinicalTrials.gov Identifier: NCT04565301

Recruitment Status : Recruiting

First Posted : September 25, 2020

Last Update Posted : June 22, 2021

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Sponsor:

Information provided by (Responsible Party):

Heba Omar Ahmed, Cairo University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative	Drug: Dexamethasone Drug: neostigmine Other: NaCl solutions	Not Applicable

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Detailed Description:

90 participants in this study will be randomized into three groups based on computer generated numbers using computerized generated random tables. The patients enrolled in the study will be transferred to the operation room and monitored all through the surgical procedure using pulse oximeter, non-invasive blood pressure and ECG.

To perform spinal anesthesia ,the patient will be positioned in the sitting position then sterilization of the back using betadine solution 5% will be done then the iliac crest will be identified and the opposite intervertebral space(L4-L5) will be marked then 5 ml of lidocaine 2% will be infiltrated in the skin and subcutaneous tissue then a spinal needle (25G) will be introduced to the intrathecal space and after ensuring that clear cere¬brospinal fluid will be in free flow injection of 15-20mg of bupivacaine 0.5% and 25mcg of fentanyl will be administrated then the patient will be positioned in the supine position.

If hypotension, (decrease in the mean arterial blood pressure of more than 20%from base line) occurs, 9mg intravenous ephedrine will be given with 200ml bolus crystalloids. If bradycardia (heart rate below 50beat / minute) occurs, 0.5mg intravenous atropine will be given. After the surgical procedure the patients will be randomly allocated using computerized generated random tables in to three equal groups and the random numbers will be concealed in closed opaque envelopes which will be kept by the senior anesthesia staff, the three groups are:

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

With the patient in the supine position, the procedural needle (Braun Stimuplex Ultra Insuflated Echogenic Needle 22G) will be inserted in plane from the anteromedial side at the mid thigh level. It will be advanced through the sartorius muscle and fascia under ultrasound guidance, using a Siemens Acuson X300 ultrasound equipped with a linear transducer after sterilization of the skin with betadine solution 5%, and the adductor canal, with the superficial femoral artery and vein within, will be identified. Once the needle tip will be located in the adductor canal, the anaesthetic solution will be injected anterior to the artery and deep into the sartorius muscle (24) then patient will be transferred to the PACU then to the ward.

Postoperative

Postoperative pain will be assessed by visual analog scale (VAS)
A fixed dose of intravenous paracetamol 1 gram will be given every 6 hours to all patients in the three groups starting from 1 hour after the ACB.
Postoperative pain assessment through VAS will be according to the scale as follow:
- Pain level 0: no pain
- Pain level1-3: mild pain
- Pain level 4-6: moderate pain
- Pain level 7-10: severe pain
Postoperative pain will be managed as follow:
- Mild pain will be treated with ketolac 30mg IV.
- Moderate pain will be treated with ketolac 30mg IV + morphine 0.07mg/kg IV.
- Severe pain will be treated with ketolac 30mg IV & morphine 0.1mg/kg IV. Then patient will be reassessed and recorded as mentioned above and the specific treatment will be repeated after 8 hours from the initial dose according to VAS.
Opioids complications such as respiratory depression will be recorded and managed supportively by oxygen mask, controlled airway and if persistent or severe hypoventilation occurs positive pressure ventilation may be needed, nausea and vomiting will be treated with ondansterone (4mg IV).

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Care Provider)
Primary Purpose:	Treatment
Official Title:	A Comparative Study Between Neostigmine and Dexamethasone as an Adjuvant to Bupivacaine in Adductor Canal Block After Knee Arthroscopy Surgery
Actual Study Start Date :	June 20, 2021
Estimated Primary Completion Date :	October 20, 2021
Estimated Study Completion Date :	October 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dexamethasone Neostigmine methylsulfate Neostigmine Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Group C 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 adductor canal block Other Name: normal saline
Active Comparator: Group D 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 adductor canal block Other Name: Decadron
Active Comparator: Group N 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 adductor canal block Other Name: prostigmin

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

morphine consumption [ Time Frame: 24 hours ]
Total amount of morphine consumed in the first 24 hours following the AC
Visual analogue scale [ Time Frame: up to 24 hours ]
VAS score at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively. As visual analouge scale (VAS) is a scale from 0 to 10 where "0" means no pain and "10" means the most severe pain.
sensory block [ Time Frame: up to 24 hours ]
Duration of sensory block at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively
Presence of Nausea and vomiting [ Time Frame: 24 hours ]
through a question answered by yes or no to identify the presence of nausea and vomiting

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565301

Locations

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Egypt
Heba Omar Ahmed Omar	Recruiting
Giza, Haram, Egypt, 12562
Contact: Heba Om Omar, Md +201128102222 hebaomar2@yahoo.com

Sponsors and Collaborators

Cairo University

More Information

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Responsible Party:	Heba Omar Ahmed, Associate professor of Anesthesia, pain management & surgical ICU, Cairo University
ClinicalTrials.gov Identifier:	NCT04565301
Other Study ID Numbers:	MS-161-2020
First Posted:	September 25, 2020 Key Record Dates
Last Update Posted:	June 22, 2021
Last Verified:	June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Dexamethasone Neostigmine Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Parasympathomimetics

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