Analgesic Efficacy of Sequential Rapid Versus Slow Intrathecal Injection Of Dexmedetomidine Followed by of Hyperbaric Bupivacaine in Inguinal Hernia Repair Surgery

Analgesic Efficacy of Sequential Rapid Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine Versus Sequential Slow Injection of Both Drugs in Patients Undergoing Unilateral Inguinal Hernia Repair Surgery

Analgesic Efficacy of Sequential Rapid Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine Versus Sequential Slow Injection of Both Drugs in Patients Undergoing Unilateral Inguinal Hernia Repair Surgery

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Analgesic Efficacy of Sequential Rapid Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine Injection in Patients Undergoing Unilateral Inguinal Hernia Repair; Drug: Analgesic Efficacy of Sequential Slow Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine in Patients Undergoing Unilateral Inguinal Hernia Repair Surgery

Detailed Description

Once enrolled in the study, patients will be randomly assigned into two groups; rapid sequential group (Group A: n= 25) and normal sequential group (Group B: n=25). Randomization will be done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. Upon arrival to the operating room, Wide bore intravenous line will be inserted, premedications (ondansetron 4 mg and midazolam 0.05 mg/Kg) will be administered, and routine monitors (Electrocardiogram - non-invasive blood pressure monitor - pulse oximeter) will be applied. The patient will be assisted into the sitting position, and sterilized surgical drapes will be placed to their back. Spinal anesthesia will be administered at L4-L5 using a complete aseptic technique. Group (A): will receive spinal anesthesia by applying sequential rapid injection of dexmedetomidine (5 µg in 0.5 ml saline, in insulin syringe within 1 second) followed by slow injection of 17.5 mg (3.5 ml within 12

-15 seconds) of 0.5% of heavy bupivacaine with no time lag between these injections. Group (B): will receive spinal anesthesia by applying normal sequential injection of 0.5 mL of 5 µg dexmedetomidine (injected over 3-4 seconds using a 5 ml syringe and mixed with cerebrospinal fluid (via barbotage), followed by slow injection of 17.5 mg (3.5 ml within 12 -15 seconds) of 0.5% of heavy bupivacaine with no time lag between these injections. Then the patient will be asked to lie down. The sensory level will be assessed by the cold ice technique every minute for 10-minutes. Motor blockade will be assessed every 5 min by the Bromage scale (4). After the T6 level is reached, the surgeon will be asked to operate. In case of failed spinal anesthesia (defined as failure to reach T6 level within 10 mins), the patient will be excluded, and further management will be according to the attending anesthetist. After spinal anaesthesia noninvasive blood pressure will be measured for then every 3 mins for 30 mins then every 5 mins till the end of operation. The occurrence of hypotension (defined as mean blood pressure <65 mmHg) will be recorded, and an anesthesiologist will be allowed to manage it by giving ephedrine (5-10 mg, intravenous [IV]) and IV fluids. If bradycardia occurred (heart rate<55 bpm), it will be managed by intravenous 0.5 mg atropine. Postoperative pain management All patients will receive acetaminophen 1gm/6 hours. Visual analogue scale (VAS) will be assessed at 0.5-, 1-, 2-, 4-, 6-, 8-, 10-, 12-,18- and 24-hour post operatively. Rescue analgesia administered in the form of (0.5-1 mg/kg) of intramuscular pethidine will be given on if VAS score was >3 Measurement tools

Patients will be monitored using:

• ECG, non-invasive blood pressure monitor, pulse oximeter.
• VAS (Visual analogue scale) pain assessment.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Kasr Alainy Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients undergoing inguinal hernia repair surgery.
• Age between 18 years and 65 years.
• Both sexes
• ASA I & ASA II

Exclusion Criteria:

• Patients refusal
• Pregnant women
• Duration of surgery more than 2 hours.
• Chronic use of opioids or tranquilizers.
• Incooperative patients e.g mentally retarded.
• Patients with any contraindications to spinal anesthesia
• Allergy to the used drugs.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (Group A): rapid sequential group	Drug: Analgesic Efficacy of Sequential Rapid Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine Injection in Patients Undergoing Unilateral Inguinal Hernia Repair; Analgesic Efficacy of Sequential Rapid Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine Injection in Patients Undergoing Unilateral Inguinal Hernia Repair Surgery
Active Comparator: (Group B): normal sequential group	Drug: Analgesic Efficacy of Sequential Slow Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine in Patients Undergoing Unilateral Inguinal Hernia Repair Surgery; Analgesic Efficacy of Sequential Slow Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine in Patients Undergoing Unilateral Inguinal Hernia Repair Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative analgesia	time from reaching the sensory level of T6 until the need of first dose of rescue analgesia	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of sensory block	defined as the time needed to lose cold sensation when using the ice-cold test at the T6 dermatomal level	20 minutes
Onset of motor block using Bromage scale	defined as the time from giving spinal anesthesia until a modified Bromage score of IV will be reached	30 minutes
VIisual Visual analouge scale Visual analogue scale (VAS) score at 0.5-, 1-, 2-, 4-, 6-, 8-, 10-, 12-, 18-and 24-hour post operatively	VAS score, a scale from 0 to 10, as 0 means no pain and 10 represents the most severe pain VAS score at 0.5-, 1-, 2-, 4-, 6-, 8-, 10-, 12-, 18-and 24-hour post operatively, a	24 hrs
Total dose of postoperative pethidine		24 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): May 20, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine; Analgesics
• Other Study ID Numbers: MD-367-2021

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