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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06253260
• Other study ID #: MD-367-2021
• Status: Completed
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: May 20, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia, Inguinal
• Postoperative Pain

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Kasr Alainy hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of postoperative analgesia	time from reaching the sensory level of T6 until the need of first dose of rescue analgesia	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Total dose of postoperative pethidine		24 hours