Bupivacaine Alone vs Bupivacaine and Dexmed in Cesarean Deliveries

Comparison of Effects of Intrathecal Hyperbaric Bupivacaine Alone Versus Hyperbaric Bupivacaine Combined With Dexmedetomidine in Cesarean Section Deliveries

The purpose of the study is to compare the onset and duration of sensory and motor block after spinal anesthesia between intrathecal bupivacaine alone vs intrathecal bupivacaine and dexmedetomidine combination.

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed Description

After approval from hospital ethical committee, parturient scheduled for elective Cesarean delivery falling in ASA II status, aged 18 - 45, with a BMI of 18-35kg/m2 will be allocated to either of the two groups B and D according to systemic randomized sampling technique, with every 3rd patient being enrolled in the study. The patients falling on odd numbers will be allocated group B and those falling on even numbers will be allocated group D. Written informed consent will be taken for enrollment in study. Performa questionnaire data will be collected by researcher herself (Annexure VII).

All parturients will be premedicated with Tab Omeprazole 20mg at 6:00 hours with a sip of water. Two 18G IV cannulas will be maintained in Operation Theater (OT). All patients will be pre-hydrated with Lactated Ringer's solution at rate of 20ml/kg by OT staff. On arrival to operating room standard monitoring consisting of pulse-oximeter, non-invasive blood pressure (NIBP) and ECG will be attached and baseline readings checked and recorded.

Intrathecal drugs will be prepared by the researcher herself. Patient's back will be prepared using aseptic measures, L3-L4 space will be identified and local anesthetic infiltrated. After 2 min 25 gauge pencil point spinal needle of B-Braun will be introduced. After obtaining free flow of CSF 2ml of 0.5% hyperbaric Bupivacaine 2 ml will be injected to Group B and 2ml of 0.5% bupivacaine mixed with 5µg dexmedetomidine will be injected in Group D, patient will be immediately placed in supine position. Timer will be started by the OT assistant as soon as the drug is injected. Spinal puncture will be performed by Trainee researcher herself who had experience of more than 200 spinal blocks.

Data collection will be done by fellow colleague of equal experience. Sensory blockade will be tested using pinprick method with a blunt 27G hypodermic needle every 1 min till loss of sensation at xiphoid (T6 level). Quality of motor blockade will be assessed by modified Bromage scale (Annexure I) at 3 mins then every 1 min till Bromage I motor block is achieved. Intra-operative hypotension (decrease in mean BP of more than 20%) will be treated with 3 - 6 mg ephedrine and bradycardia (HR < 60bpm) will be treated with 0.4mg atropine. Post-operative analgesia will be assessed half hourly for the 1st 3 hours, then 1 hourly using visual analogue scale (0-10) till the time to 1st request for analgesics or VAS ≥ 4, whichever comes first. Injection tramadol 50mg and injection paracetamol 1g will be used as rescue analgesia. Injection paracetamol will be given 6 hourly after the first dose for 24 hours. Duration of motor block will also be assessed via the Bromage Score along with assessment of VAS score. Time to regaining of the full flexion of knees and hips will be recorded.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rida Qureshi; Phone Number: +923189301930; Email: ridaqureshi00@gmail.com

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Recruiting
    • KRL Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Pregnant females of age 18-45 years
2. ASA physical status II
3. Body Mass Index (BMI) of 18-35 kg/m2

Exclusion Criteria:

1. Any relative or absolute contra-indication to spinal anesthesia
2. Allergy to dexmedetomidine
3. Subjects with pre-existing non-obstetric medical co-morbidities
4. Patient refusal for spinal technique
5. Obstetrics emergencies

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Bupivacaine; Participants to be given 2ml of 0.5% bupivacaine intrathecally for elective cesarean section deliveries.
Active Comparator: Bupivacaine + Dexmedetomidine; Participants to be given 5mcg dexmedetomidine in addition to 2ml of 0.5% bupivacaine intrathecally for elective cesarean section deliveries.	Drug: Dexmedetomidine; 5mcg dexmedetomidine to be given intrathecally along with 0.5% bupivacaine.; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of Sensory Block	Mean time to loss of sensation to pin prick using a 27 G blunt needle at the level of the xiphoid (T6) from the time of injection of drug intrathecally.	8 mins
Onset of Motor Block	Mean time taken to reach Bromage Score I from the time of injection of drug intrathecally	8 mins
Duration of Sensory Block	Mean time from spinal injection to the 1st request for analgesics or VAS ≥ 4; whichever comes first.	8 hours
Duration of Motor Block	Mean time from spinal injection to regaining of Bromage score 4	8 hours

Collaborators and Investigators

• Sponsor: KRL Hospital, Islamabad
• Investigators: Principal Investigator: Rida Qureshi, KRL Hospital, Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Anticipated): September 15, 2022
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: Dexmed 1

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