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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
- Recruiting
Makassed General Hospital
Beirut
Zoher Naja, MD, +9611636000 ext. 6405, zouhnaja@yahoo.com
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.
- Conditions
- Major Abdominal Surgery
- 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 group | Role | What they receive |
|---|---|---|
| PVB group | Experimental | Patients will receive nerve stimulator guided paravertebral block Receives: Drug: Paravertebral block; Procedure: Major abdominal surgery |
| GA group | Experimental | Patients 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.
Number of patients admitted to Intensive Care Unit (ICU)
Measured: 48 hours postoperatively
Secondary outcomes (2)
Hemodynamic stability measured through Mean Arterial Pressure (mmHg)
Measured: 48 hours postoperatively
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.
- First posted27 Aug 2015 (estimated)
- Study start1 May 2016
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoher Naja, Makassed General Hospital
- Investigators
- Zoher Naja, MD, Principal investigator, Makassed General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block Versus General Anesthesia for Major Abdominal Surgery in Elderly: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02534012
- Acronym / sponsor ID
- 182015
- Conditions
- Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVB group | Experimental | Drug: Paravertebral block, Procedure: Major abdominal surgeryPatients will receive nerve stimulator guided paravertebral block |
| GA group | Experimental | Drug: General anesthesia, Procedure: Major abdominal surgeryPatients will receive general anesthesia |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age 70 years or older admitted for major abdominal surgery
Key exclusion criteria (4 listed)
- Known history of allergic reactions to local anesthesia
- Neurological disorders
- Bleeding disorders
- Infection at site of injection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral blockBilateral 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. | Drug | PVB group |
| General anesthesiaAnesthesia 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. | Drug | GA group |
| Major abdominal surgery | Procedure or surgery | GA group, PVB group |
Primary outcome
Number of patients admitted to Intensive Care Unit (ICU)
Time frame: 48 hours postoperatively
2 secondary outcomes
Hemodynamic stability measured through Mean Arterial Pressure (mmHg)
Time frame: 48 hours postoperatively
Hemodynamic stability measured through heart rate (beats per minute)
Time frame: 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
Related trials for Major Abdominal Surgery
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
Postoperative Acute Kidney Injury
Active, not recruitingPhase 4
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
Laparotomy, Bowel Obstruction
Not yet recruiting
AI-Assisted Education Before Surgery to Prevent Lung Complications in Older Surgical Patients
Postoperative Pulmonary Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoher Naja, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
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.