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Major Abdominal SurgeryNCT02534012

Paravertebral Block vs. General Anesthesia for Major Abdominal Surgery

A study testing Paravertebral block, General anesthesia and Major abdominal surgery in people with Major Abdominal Surgery, run by Makassed General Hospital at 1 site in Lebanon.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Elderly patients are usually presented with higher risk for developing cardiopulmonary complications after general anesthesia (GA). Bilateral paravertebral block (PVB) has been associated with favorable outcomes in patients undergoing ventral hernia repair. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Major Abdominal Surgery
What is being tested?
Paravertebral block, General anesthesia and Major abdominal surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteLebanon
Study dates
1 May 2016to Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age 70 years or older admitted for major abdominal surgery

Who cannot join

  • Known history of allergic reactions to local anesthesia
  • Neurological disorders
  • Bleeding disorders
  • Infection at site of injection.

Trial locations and contacts

1 site in 1 country.

Lebanon1 site, 1 recruiting
  • Makassed General Hospital

    Beirut

    Zoher Naja, MD, +9611636000 ext. 6405, zouhnaja@yahoo.com

    Recruiting

Other trials in Lebanon

About this study

Official title: Paravertebral Block Versus General Anesthesia for Major Abdominal Surgery in Elderly: a Prospective Randomized Clinical Trial

Elderly patients are usually presented with higher risk for developing cardiopulmonary complications after general anesthesia (GA). Bilateral paravertebral block (PVB) has been associated with favorable outcomes in patients undergoing ventral hernia repair. Hence, elderly patients undergoing major abdominal surgery may benefit from PVB anesthetic technique.

Read the detailed description

Introduction

Elderly patients are usually presented with higher risk for developing cardiopulmonary complications after general anesthesia (GA). The risk of adverse events in elderly patients increases with the combination of intraoperative fentanyl, opioid premedication and neuromuscular blockers. Bilateral paravertebral block (PVB) has been associated with favorable outcomes in patients undergoing ventral hernia repair. Hence, elderly patients may benefit from PVB anesthetic technique.

The objective of the study is to compare PVB versus GA for elderly patients undergoing major abdominal surgery. The primary outcome measure is admission to the Intensive Care Unit (ICU). The secondary objective is postoperative analgesic consumption.

Methods

Following approval from the Institutional Review Board, 60 patients aged 70 years or older scheduled to undergo major abdominal surgery from May 2016 till December 2020 will be included in the study. Consent will be obtained from the patients or their family member. Patients will be divided into two groups. Group I will receive PVB while group II will receive GA.

Demographic variables including age, gender, height, weight, and ASA physical status will be collected for each patient. Intraoperative hemodynamic data such as mean arterial pressure (MAP) and heart rate (HR) are noted. Moreover, surgery duration, admission to ICU and hospital stay are recorded. Morbidity and mortality rates will also be obtained.

General Anesthesia technique Anesthesia is induced with 1 µg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 µg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen. Any hemodynamic change of 25% results in a gradual increase or decrease of the sevoflurane concentration.

Paravertebral Block Technique Bilateral nerve stimulator-guided PVB is performed while patients are in lateral decubitis position. The number and level of injections depend on the type of surgery and length of incision.

The appropriate levels for the PVBs are determined by palpation of the spinous processes. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline on both sides. After aseptic preparation of the skin, 0.3 mL 2% lidocaine is infiltrated at the injection sites. A 22-G nerve stimulation needle (Stimuplex; B. Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to continue to produce muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA.

Depending on patient weight, 3-5 mL of the local anaesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg mL-1, and 4 mL bupivacaine 0.5%.

In case of PVB failure, patients will be converted to GA.

Admission to ICU and hospital stay Patients who are hemodynamically stable, conscious and do not feel pain will be transferred from the PACU to the floor. On the other hand, patients will be admitted to ICU if they are unconscious, intubated, and hemodynamically unstable. Patients will be discharged from hospital when they are able to drink, eat and do not have complications.

Morbidity and complications Morbidity is defined as having chest infection, kidney failure, myocardial infarction, and dementia.

Being tested
Paravertebral block, General anesthesia, Major abdominal surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paravertebral blockDrug

    Bilateral nerve stimulator-guided PVB is performed while patients are in lateral decubitis position. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline on both sides. After aseptic preparation of the skin, 0.3 mL 2% lidocaine is infiltrated at the injection sites. A 22-G nerve stimulation needle (Stimuplex, B.Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to continue to produce muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA. Depending on patient weight, 3-5 mL of the local anaesthetic mixture is injected at each injection site.

  • General anesthesiaDrug

    Anesthesia is induced with 1 µg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg nimbex (cisatracurium). Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 µg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen.

  • Major abdominal surgeryProcedure or surgery

Study groups in NCT02534012
Study groupRoleWhat they receive
PVB groupExperimentalPatients will receive nerve stimulator guided paravertebral block
Receives: Drug: Paravertebral block; Procedure: Major abdominal surgery
GA groupExperimentalPatients will receive general anesthesia
Receives: Drug: General anesthesia; Procedure: Major abdominal surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients admitted to Intensive Care Unit (ICU)

    Measured: 48 hours postoperatively

Secondary outcomes (2)
  1. Hemodynamic stability measured through Mean Arterial Pressure (mmHg)

    Measured: 48 hours postoperatively

  2. Hemodynamic stability measured through heart rate (beats per minute)

    Measured: 48 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2015 (estimated)
  2. Study start1 May 2016
  3. Primary completionApr 2022 (estimated)
  4. Study completionApr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02534012
Sponsor's protocol ID
182015
Status last verified
Jan 2022
First submitted
20 Aug 2015
Last updated
18 Jan 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Paravertebral block, General anesthesia and Major abdominal surgery in people with Major Abdominal Surgery, run by Makassed General Hospital at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zoher Naja, MD (+9611636000 ext. 6405, zouhnaja@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients admitted to Intensive Care Unit (ICU) (time frame: 48 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.

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