Neostigmine and Dexamethasone in Adductor Canal Block

A Comparative Study Between Neostigmine and Dexamethasone as an Adjuvant to Bupivacaine in Adductor Canal Block After Knee Arthroscopy Surgery

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Other: NaCl solutions; Drug: Dexamethasone; Drug: neostigmine

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 neostigmine: 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 dexamethasone: 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 control: 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

1. Postoperative pain will be assessed by visual analog scale (VAS)
2. 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.

3. 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

4. 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.
5. 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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Kasr Alainy hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: prostigmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption	Total amount of morphine consumed in the first 24 hours following the AC	24 hours
Visual analogue scale	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.	up to 24 hours
sensory block	Duration of sensory block at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively	up to 24 hours
Presence of Nausea and vomiting	through a question answered by yes or no to identify the presence of nausea and vomiting	24 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Heba Omar, associate professor of anesthesia and surgical ICU, faculty of medicine, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2021
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Cholinesterase Inhibitors; Parasympathomimetics; Dexamethasone; Neostigmine
• Other Study ID Numbers: MS-161-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No