Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery

Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery: A Randomized Controlled Trial

The aim of this study is to compare the effects of intrathecal injection of hyperbaric bupivacaine versus injection of hyperbaric and isobaric bupivacaine in patients undergoing lower abdominal surgery.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Lower Abdominal Surgery; Hyperbaric Bupivacaine; Isobaric Bupivacaine
• Intervention / Treatment: Drug: Group A (hyperbaric bupivacaine); Drug: Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)

Detailed Description

Spinal anesthesia is one of the most commonly used nerve block procedures for surgical operations involving the lower abdomen, the perineum, and the lower limbs, owing to its quick effect and cost-effectiveness. Spinal anesthesia is advantageous in that it uses a small dose of anesthesia, is simple to perform, and offers a rapid onset of action, reliable surgical analgesia, and good muscle relaxation.

The Baricity of a solution is defined as the ratio of the density of the solution to that of the cerebrospinal fluid (CSF). The most common anesthetic used for SA in obstetric and non-obstetric surgery is bupivacaine, which can be formulated as an isobaric or hyperbaric solution. Baricity differences between spinal anesthetic solutions are thought to affect hemodynamic parameters and distribution within the subarachnoid space, which may, in turn, affect the onset, extent, and duration of sensory block as well as side effects.

Spinal anesthesia has been linked to different adverse effects, out of which hypotension is most common complication. The incidence of hypotension is 25-75% in general population. Factors that increase the risk of hypotension include patient factors (advanced age, pregnancy, obesity, diabetes mellitus, hypertension, and anemia) and technical factors such as a block level at or above T5, use of opioids during premedication, and high local anesthetic dosages.

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Helwan, Cairo, Egypt
      • Helwan University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age between 18-65 years old.
• Both sexes.
• American Society of Anaesthesia (ASA) I to II.
• Undergoing lower abdominal or urological surgery under spinal anesthesia

Exclusion Criteria:

• Allergy to amide.
• Patients with a significant history of substance abuse.
• Patients with diabetes mellitus, neurological or cardiovascular diseases.
• Patients with neuromuscular diseases.
• Pregnant patients.

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
Experimental: Group A (hyperbaric bupivacaine); Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution.	Drug: Group A (hyperbaric bupivacaine); Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution
Experimental: Group B (Mixture of Hyperbaric and Isobaric Bupivacaine); Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution.	Drug: Group B (Mixture of Hyperbaric and Isobaric Bupivacaine); Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension	Blood pressure was recorded using standard non-invasive monitors at 5, 10, 15, 20, 25, 30, 45, and 60 min, then hourly until 3 h post-injection. Hypotension was defined as a decrease in mean arterial pressure of more than 30% from baseline.	3 hours post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate was recorded using standard non-invasive monitors at 5, 10, 15, 20, 25, 30, 45, and 60 min, then hourly until 3 h post-injection.	3 hours post-injection
Mean arterial pressure (MAP)	Mean arterial pressure was recorded using standard non-invasive monitors at 5, 10, 15, 20, 25, 30, 45, and 60 min, then hourly until 3 h post-injection.	3 hours post-injection

Collaborators and Investigators

• Sponsor: Helwan University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: September 17, 2023
• First Submitted That Met QC Criteria: September 17, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 48-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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