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Completed

NCT Number: NCT06050044

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helwan University

Helwan, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group A (hyperbaric bupivacaine)

Drug

Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution

Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)

Drug

Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution

Primary outcomes

  1. Incidence of hypotension

    Time frame: 3 hours post-injection

    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.

Secondary outcomes

  1. Heart rate

    Time frame: 3 hours post-injection

    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.

  2. Mean arterial pressure (MAP)

    Time frame: 3 hours post-injection

    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.

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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