Opioid UseNCT05668845
Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia.
A study testing PG-ANB performed at the outset of LSG and PG-ANB performed at the end of the LSG in people with Opioid Use and Anesthesia Morbidity, run by Universidad Simón Bolívar at 1 site in Colombia.
Trial summary
To evaluate the effect of early autonomic blockade on the consumption of remifentanil and halogenated anesthesia in the intraoperative period during laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Anesthesia Morbidity
- What is being tested?
- PG-ANB performed at the outset of LSG and PG-ANB performed at the end of the LSG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2023to 1 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -all adult patients scheduled for LSG at each participating institution.
Who cannot join
- the inability to perform a PG-ANB because of anatomical difficulties
- the need for revisional surgery
- the need for concomitant hiatal hernia repair or other surgical procedures
- conversion to open surgical procedures
- allergies to local anesthetics or medication described in the anesthesia protocol
- intraoperative complications (e.g., visceral or vascular perforations)
- anesthesia-related complications requiring admission to intensive care
Trial locations and contacts
1 site in 1 country.
Colombia1 site
clinicas Portoazul e Iberoamerica
Barranquilla, Atlántico, 080020
About this study
Official title: Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia. Impact on Anesthetic Agents Consumption: A Randomized Clinical Trial Protocol
To evaluate the effect of early autonomic blockade on the consumption of remifentanil and halogenated anesthesia in the intraoperative period during laparoscopic sleeve gastrectomy.
Read the detailed description
Balanced general anesthesia, even if combined with local anesthesia or parietal blocks such as transversus abdominis plane (TAP), subcostal, or pararectal blocks, is insufficient to block the autonomic impulses released during most intra-abdominal visceral surgeries, especially in laparoscopic sleeve gastrectomy (LSG). These impulses are, in part, responsible for the hemodynamic changes observed during different phases of LSG and the subsequent visceral pain and associated symptoms, such as nausea and vomiting, observed in a substantial number of patients in the immediate postoperative period after LSG and other minimally invasive procedures. Visceral pain substantially impacts patients' quality of life, recovery time, nursing time allocation, and resultant risk of opioid abuse. Nausea, food intolerance, and pain are responsible for most readmissions after LSG and other bariatric procedures. Many of these patients have associated severe respiratory impairments and other comorbidities. They often need increased amounts of halogenated anesthetics, opioid analgesics, antiemetics, and other anesthetic modalities such as epidural anesthesia. A recent randomized clinical trial (RCT) demonstrated that a novel approach, namely paragastric autonomic neural blockade (PG-ANB), is safe and effective in addressing visceral pain while reducing the need for analgesics, including opioids and the decreasing nausea and vomiting in the first 24 hours after a laparoscopic sleeve gastrectomy. In an observational series, we found that by performing PG-ANB as the first step in LSG, the need for morphine-equivalent doses and halogenated anesthetics diminished, and hemodynamic stability increased while maintaining the previously reported reduction of postoperative visceral pain and associated symptoms. Similarly, when implementing a variation of the autonomic blockade targeting proper pathways as an early step in cholecystectomy, the same beneficial effects were observed in affected patients.
- Conditions
- Opioid Use, Anesthesia Morbidity
- Being tested
- PG-ANB performed at the outset of LSG, PG-ANB performed at the end of the LSG
- Keywords
- Autonomic, Blockade, Opioids, Anesthetics, Recovery time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG-ANB performed at the outset of LSGOther
The paragastric lesser omentum neural block is performed with a 25-gauge needle attached to a venous catheter extension introduced through the left 12-mm port. The needle is capped during its introduction, and the cap is removed inside the abdomen using a grasper and kept under direct vision. Infiltration of 20 mL of non-diluted 0.5% bupivacaine is performed at six levels with careful aspiration preceding fluid infiltration. Four areas are adjacent to the vagus nerves and branches, and two are in the vicinity of the common hepatic and left gastric arteries. This is performed at the outset of the LSG.
PG-ANB performed at the end of the LSGOther
The paragastric lesser omentum neural block is performed with a 25-gauge needle attached to a venous catheter extension introduced through the left 12-mm port. The needle is capped during its introduction, and the cap is removed inside the abdomen using a grasper and kept under direct vision. Infiltration of 20 mL of non-diluted 0.5% bupivacaine is performed at six levels with careful aspiration preceding fluid infiltration. Four areas are adjacent to the vagus nerves and branches, and two are in the vicinity of the common hepatic and left gastric arteries. This is performed at the end of the LSG>
| Study group | Role | What they receive |
|---|---|---|
| PG-ANB performed at the outset of LSG | Experimental | PG-ANB is performed early in the procedure as a first step before starting the sleeve gastrectomy. Receives: Other: PG-ANB performed at the outset of LSG |
| PG-ANB performed at the end of LSG | Active comparator | PG-ANB is performed at the end of the sleeve gastrectomy Receives: Other: PG-ANB performed at the end of the LSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Remifentanil consumption
The amount of remifentanil administered will be calculated based on the amount of the consumed mix and reported as total mcg and mcg/kg/min.
Measured: duration of the anesthesia
Intraoperative consumption of the halogenated agent (sevoflurane)
The anesthetic machine will determine the administered amount of sevoflurane (Dräger Primus) which will be reported in ml/min.
Measured: duration of the anesthesia
Secondary outcomes (1)
recovery from anesthesia measured by the Modified Aldrete Scale
The Modified Aldrete scale from 0 to 15 (a higher score correlates with better recovery from anesthesia) will be assessed and recorded 15 minutes and 1 hour after surgery.
Measured: one hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Feb 2023
- Primary completion15 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Simón Bolívar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Pantoja, MD, Study chair, Universidad Simón Bolívar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668845
- Sponsor's protocol ID
- PRO-CEI-USB-CE-0394-01
- Other IDs
- PRO-CEI-USB-CE-0394-02
- Status last verified
- May 2023
- First submitted
- 26 Nov 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.
PubMed 36050617Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.
PubMed 38091501
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia. Impact on Anesthetic Agents Consumption: A Randomized Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT05668845
- Acronym / sponsor ID
- PRO-CEI-USB-CE-0394-01
- Conditions
- Opioid Use, Anesthesia Morbidity
- Keywords
- Autonomic, Blockade, Opioids, Anesthetics, Recovery time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Universidad Simón BolívarUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 30 Dec 2022 (actual)
- 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.
To evaluate the effect of early autonomic blockade on the consumption of remifentanil and halogenated anesthesia in the intraoperative period during laparoscopic sleeve gastrectomy.
Detailed description
Balanced general anesthesia, even if combined with local anesthesia or parietal blocks such as transversus abdominis plane (TAP), subcostal, or pararectal blocks, is insufficient to block the autonomic impulses released during most intra-abdominal visceral surgeries, especially in laparoscopic sleeve gastrectomy (LSG). These impulses are, in part, responsible for the hemodynamic changes observed during different phases of LSG and the subsequent visceral pain and associated symptoms, such as nausea and vomiting, observed in a substantial number of patients in the immediate postoperative period after LSG and other minimally invasive procedures. Visceral pain substantially impacts patients' quality of life, recovery time, nursing time allocation, and resultant risk of opioid abuse. Nausea, food intolerance, and pain are responsible for most readmissions after LSG and other bariatric procedures. Many of these patients have associated severe respiratory impairments and other comorbidities. They often need increased amounts of halogenated anesthetics, opioid analgesics, antiemetics, and other anesthetic modalities such as epidural anesthesia. A recent randomized clinical trial (RCT) demonstrated that a novel approach, namely paragastric autonomic neural blockade (PG-ANB), is safe and effective in addressing visceral pain while reducing the need for analgesics, including opioids and the decreasing nausea and vomiting in the first 24 hours after a laparoscopic sleeve gastrectomy. In an observational series, we found that by performing PG-ANB as the first step in LSG, the need for morphine-equivalent doses and halogenated anesthetics diminished, and hemodynamic stability increased while maintaining the previously reported reduction of postoperative visceral pain and associated symptoms. Similarly, when implementing a variation of the autonomic blockade targeting proper pathways as an early step in cholecystectomy, the same beneficial effects were observed in affected patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| PG-ANB performed at the outset of LSG | Experimental | Other: PG-ANB performed at the outset of LSGPG-ANB is performed early in the procedure as a first step before starting the sleeve gastrectomy. |
| PG-ANB performed at the end of LSG | Active comparator | Other: PG-ANB performed at the end of the LSGPG-ANB is performed at the end of the sleeve gastrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -all adult patients scheduled for LSG at each participating institution.
Key exclusion criteria (7 listed)
- the inability to perform a PG-ANB because of anatomical difficulties
- the need for revisional surgery
- the need for concomitant hiatal hernia repair or other surgical procedures
- conversion to open surgical procedures
- allergies to local anesthetics or medication described in the anesthesia protocol
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 |
|---|---|---|
| PG-ANB performed at the outset of LSGThe paragastric lesser omentum neural block is performed with a 25-gauge needle attached to a venous catheter extension introduced through the left 12-mm port. The needle is capped during its introduction, and the cap is removed inside the abdomen using a grasper and kept under direct vision. Infiltration of 20 mL of non-diluted 0.5% bupivacaine is performed at six levels with careful aspiration preceding fluid infiltration. Four areas are adjacent to the vagus nerves and branches, and two are in the vicinity of the common hepatic and left gastric arteries. This is performed at the outset of the LSG. | Other | PG-ANB performed at the outset of LSG |
| PG-ANB performed at the end of the LSGThe paragastric lesser omentum neural block is performed with a 25-gauge needle attached to a venous catheter extension introduced through the left 12-mm port. The needle is capped during its introduction, and the cap is removed inside the abdomen using a grasper and kept under direct vision. Infiltration of 20 mL of non-diluted 0.5% bupivacaine is performed at six levels with careful aspiration preceding fluid infiltration. Four areas are adjacent to the vagus nerves and branches, and two are in the vicinity of the common hepatic and left gastric arteries. This is performed at the end of the LSG> | Other | PG-ANB performed at the end of LSG |
Primary outcome
Intraoperative Remifentanil consumption
Time frame: duration of the anesthesia
The amount of remifentanil administered will be calculated based on the amount of the consumed mix and reported as total mcg and mcg/kg/min.
Intraoperative consumption of the halogenated agent (sevoflurane)
Time frame: duration of the anesthesia
The anesthetic machine will determine the administered amount of sevoflurane (Dräger Primus) which will be reported in ml/min.
1 secondary outcome
recovery from anesthesia measured by the Modified Aldrete Scale
Time frame: one hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 36050617Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.
- Derived from this study: PubMed 38091501Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.
- Individual participant dataSharing planned: No
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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.
Rafael Pantoja, MD study chair
Universidad Simón Bolívar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PG-ANB performed at the outset of LSG and PG-ANB performed at the end of the LSG in people with Opioid Use and Anesthesia Morbidity, run by Universidad Simón Bolívar at 1 site in Colombia.
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 7 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: finished, as of the sponsor's last update on 9 May 2023. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Remifentanil consumption (time frame: duration of the anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668845, which also lists 2 linked publications.
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 9 May 2023.