Pain, PostoperativeNCT06238830
Evaluation of Multimodal Analgesia With NOL
An observational study of Pain, Postoperative and Analgesia, run by Ankara City Hospital Bilkent.
Trial summary
The study will include 80 patients undergoing Laparoscopic Cholecystectomy Surgery as part of elective requirements. The study is a single-center, prospective, randomized controlled trial The aim of the study is 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Analgesia
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective laparoscopic cholecystectomy.
Who may be able to join
- Individuals aged between 18 and 65 years old
- Those undergoing elective laparoscopic cholecystectomy
- Patients with ASA risk scores of I and II
- Body Mass Index (BMI) < 35 kg/m2
- Patients who have provided informed consent before the procedure
- Individuals who are literate and capable of giving consent.
Who cannot join
- Patients under 18 years of age and those over 65 years of age
- Individuals with an ASA score of III or higher
- Cases with a surgical duration of less than 60 minutes
- Emergency surgeries
- Those with a history of abdominal surgery
- Pregnant or lactating patients
Show all 13Show fewer
- Individuals with coagulopathy or using anticoagulant medications
- Those allergic to local anesthetics
- Individuals with localized infection at the injection site
- Patients without the ability to use Patient Controlled Analgesia (PCA) and assess Visual Analog Scale (VAS)
- Patients with peripheral nerve disease
- Individuals with kidney failure and congestive heart failure
- Patients undergoing elective Laparoscopic Cholecystectomy (LK) due to malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
The study will include 80 patients undergoing Laparoscopic Cholecystectomy Surgery as part of elective requirements. The study is a single-center, prospective, randomized controlled trial
The aim of the study is
Read more
- To investigate the effectiveness of multimodal analgesia, which includes the newly introduced external oblique intercostal plane block, with the assistance of NOL (Nociception Level), in the management of postoperative pain following commonly performed Laparoscopic Cholecystectomy surgeries.
- This approach is intended to objectively assess changes in postoperative recovery scores
Patients will be divided into two groups: the Multimodal Analgesia group (Group M), where Erector Obliq Interfascial Plane (EOIP) block, NSAID, and magnesium infusion will be administered, and the control group (Group K).
Read the detailed description
In the elective laparoscopic cholecystectomy procedures to be performed in the general surgery operating room for 80 patients, 80 envelopes containing written papers indicating the Multimodal Analgesia group (Group M) and the control group (Group K) will be prepared. On the morning of the operation, an envelope will be randomly drawn by operating room personnel in a blinded manner to determine the patient's inclusion group. The patients will be randomized into two groups: the Multimodal Analgesia group (Group M), receiving Erector Oliq Interfascial Plane (EOIP) block, NSAID, and magnesium infusion, and the control group (Group K).
Patients will be informed about the procedures to be performed before the surgery, and written consent will be obtained. After patients are taken to the operating table, standard ASA monitoring (electrocardiogram, non-invasive blood pressure, O2 saturation, body temperature) along with NOL (Nociception Level) and BIS (Bispectral Index) monitoring will be applied. A peripheral venous line will be established on the dorsum of the hand for normal saline infusion. All blocks will be performed under ultrasound guidance.
In Group M, after routine anesthesia induction, intravenous magnesium loading of 30 mg/kg will be followed by an infusion of 10 mg/kg/hour. Subsequently, in the supine position, after the necessary field preparation and ultrasound (USG) setup, a linear ultrasound probe will be positioned sagittally between the mid-clavicular and anterior axillary lines at the level of the 6th rib, with the orientation marker pointing cranially. Identification of the 6th rib can be achieved in two ways: either by placing the ultrasound probe at the level of the lower costal margin where the 10th rib is located and then counting upwards, or by identifying the 7th rib at the level of the xiphoid process and then moving the ultrasound probe one rib upward.
The ultrasound probe will then be rotated to obtain a paramedian sagittal oblique view, with the cranial end slightly medial and the caudal end lateral, approximately 1 to 2 cm medial to the anterior axillary line. Sequentially, from superficial to deep, the following structures will be identified: skin, subcutaneous tissue, external oblique muscle, intercostal muscles between the ribs, pleura, and lung.
For the injection, the skin entry point will be at the medial edge of the anterior axillary line, just cranial to the 6th rib level, using a peripherally directed block needle (Echoplex+, VygonTM, France) advanced in a superomedial to inferolateral plane along the external oblique muscle. The tip of the peripherally directed block needle will be adjusted to the tissue plane between the external oblique and intercostal muscles at the caudal end of the 6th rib and 6th-7th intercostal space. A sterile preparation of 20 mL 0.25% Bupivacaine will be injected into the tissue plane between the 6th and 7th ribs using the hydrodissection technique, and then the peripherally directed block needle will be directed caudally towards the eighth rib.
Using the 'in-plane' method parallel to the ultrasound probe, a negative aspiration will be performed, and a total of 20 mL 0.25% bupivacaine will be injected. The distribution of local anesthetic (LA) will be monitored with ultrasound during the injection. The procedure will be applied unilaterally. Post-desufflation, patients will receive 50 mg dexketoprofen intravenously as standard analgesia.
In Group K, 50 mg dexketoprofen intravenous NSAID will be administered as standard analgesia, serving as the control group.
- Conditions
- Pain, Postoperative, Analgesia
- Keywords
- multimodal analgesia, nociceptive level index, NOL, External Oblique Intercostal Plane Block, EIOB
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GROUP M | In patients undergoing elective Laparoscopic Cholecystectomy Surgery, after routine anesthesia induction, a magnesium loading dose of 30 mg/kg will be administered intravenously. Subsequently, a magnesium infusion will be initiated at a rate of 10 mg/kg/hour. Afterward, in the supine position, necessary field preparation and ultrasound (USG) setup will be conducted to administer the External Oblique Intercostal Plane (EOIP) block.The procedure will be applied unilaterally. After desufflation, patients will receive 50 mg dexketoprofen as standard analgesia administered intravenously as a non-steroidal anti-inflammatory drug (NSAID). | |
| GROUP K | As part of standard analgesia, 50 mg dexketoprofen, administered intravenously as a non-steroidal anti-inflammatory drug (NSAID), will be applied, and these patients will be considered as the control group. All patients will undergo general anesthesia induction with 1 µg/kg fentanyl, 2-3 mg/kg propofol, and 0.6 mg/kg rocuronium bromide. During anesthesia maintenance, a mixture of 50% O2 and air will be administered, and sevoflurane will be used at a minimum alveolar concentration of 0.8 (with a target MAC value of 0.8-1.2). Additionally, remifentanil will be administered at a rate of 0.01-0.2 mcg/kg/min. The remifentanil dose range will be increased if the patient\'s Nociceptive Level (NOL) value remains elevated for 2 minutes when it exceeds 25. BIS monitoring will be performed for all patients, and the BIS value will be maintained between 40-50. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Multimodal Analgesia on the Nociceptive Level İndex(NOL)
The NOL index is a single number between 0 and 100. A NOL between 0 and 25 represents a physiologically suppressed response adequately inhibiting harmful stimuli, indicating sufficient analgesia. A NOL index greater than 25 (continuous or fluctuating) for multiple minutes signifies the patient is perceiving pain. Higher values indicate a stronger nociceptive response. An index consistently below 10 for more than a minute may suggest excessive anti-nociception, prompting consideration for reducing analgesics. If regional analgesia is employed, lower NOL values are anticipated.
The dosage of remifentanil will be increased if the patient's NOL value remains elevated for 2 minutes when it surpasses 25.The number of changes in Ultiva dosage, NOL values will be recorded before intubation, after intubation, during thoracic entry, and during inflation and deflation, as well as at the time of extubation.
Measured: during surgery time
Secondary outcomes (2)
Change From Baseline in Postoperative Recovery Scores on the Visual Analog Scale at Postoperative 30 Minutes
The patients will be admitted to the postoperative recovery room. Modified Aldrete scores, PACU discharge, and opioid requirements during this period will be assessed based on postoperative awakening Visual Analog Scale (VAS) values at 0 minutes, 15 minutes, and 30 minutes, considering a value of between 0-10 for VAS. As part of the standard analgesia protocol, patients will receive perioperative 50 mg dexketoprofen. During the postoperative period, VAS monitoring will be conducted, and when VAS values exceed 4, a rescue analgesic of 50 mg tramadol intravenously will be administered and recorded as additional analgesic need.
Measured: postoperative 30 minute
The intensity of nausea and vomiting
Starting from the postoperative recovery room, nausea and vomiting will be assessed. The intensity of nausea and vomiting will be recorded using the following scoring system:
0: None
- Nausea
- Retching
- Vomiting
Measured: postoperative 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AYÇA TUBA DUMANLI ÖZCAN, Principal investigator, ANKARA BİLKENT CİTY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238830
- Sponsor's protocol ID
- E2-23-4785
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multimodal Analgesia With NOL
- ClinicalTrials.gov ID
- NCT06238830
- Acronym / sponsor ID
- E2-23-4785
- Conditions
- Pain, Postoperative, Analgesia
- Keywords
- multimodal analgesia, nociceptive level index, NOL, External Oblique Intercostal Plane Block, EIOB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 2 Feb 2024 (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.
The study will include 80 patients undergoing Laparoscopic Cholecystectomy Surgery as part of elective requirements. The study is a single-center, prospective, randomized controlled trial
The aim of the study is
- To investigate the effectiveness of multimodal analgesia, which includes the newly introduced external oblique intercostal plane block, with the assistance of NOL (Nociception Level), in the management of postoperative pain following commonly performed Laparoscopic Cholecystectomy surgeries.
- This approach is intended to objectively assess changes in postoperative recovery scores
Patients will be divided into two groups: the Multimodal Analgesia group (Group M), where Erector Obliq Interfascial Plane (EOIP) block, NSAID, and magnesium infusion will be administered, and the control group (Group K).
Detailed description
In the elective laparoscopic cholecystectomy procedures to be performed in the general surgery operating room for 80 patients, 80 envelopes containing written papers indicating the Multimodal Analgesia group (Group M) and the control group (Group K) will be prepared. On the morning of the operation, an envelope will be randomly drawn by operating room personnel in a blinded manner to determine the patient's inclusion group. The patients will be randomized into two groups: the Multimodal Analgesia group (Group M), receiving Erector Oliq Interfascial Plane (EOIP) block, NSAID, and magnesium infusion, and the control group (Group K).
Patients will be informed about the procedures to be performed before the surgery, and written consent will be obtained. After patients are taken to the operating table, standard ASA monitoring (electrocardiogram, non-invasive blood pressure, O2 saturation, body temperature) along with NOL (Nociception Level) and BIS (Bispectral Index) monitoring will be applied. A peripheral venous line will be established on the dorsum of the hand for normal saline infusion. All blocks will be performed under ultrasound guidance.
In Group M, after routine anesthesia induction, intravenous magnesium loading of 30 mg/kg will be followed by an infusion of 10 mg/kg/hour. Subsequently, in the supine position, after the necessary field preparation and ultrasound (USG) setup, a linear ultrasound probe will be positioned sagittally between the mid-clavicular and anterior axillary lines at the level of the 6th rib, with the orientation marker pointing cranially. Identification of the 6th rib can be achieved in two ways: either by placing the ultrasound probe at the level of the lower costal margin where the 10th rib is located and then counting upwards, or by identifying the 7th rib at the level of the xiphoid process and then moving the ultrasound probe one rib upward.
The ultrasound probe will then be rotated to obtain a paramedian sagittal oblique view, with the cranial end slightly medial and the caudal end lateral, approximately 1 to 2 cm medial to the anterior axillary line. Sequentially, from superficial to deep, the following structures will be identified: skin, subcutaneous tissue, external oblique muscle, intercostal muscles between the ribs, pleura, and lung.
For the injection, the skin entry point will be at the medial edge of the anterior axillary line, just cranial to the 6th rib level, using a peripherally directed block needle (Echoplex+, VygonTM, France) advanced in a superomedial to inferolateral plane along the external oblique muscle. The tip of the peripherally directed block needle will be adjusted to the tissue plane between the external oblique and intercostal muscles at the caudal end of the 6th rib and 6th-7th intercostal space. A sterile preparation of 20 mL 0.25% Bupivacaine will be injected into the tissue plane between the 6th and 7th ribs using the hydrodissection technique, and then the peripherally directed block needle will be directed caudally towards the eighth rib.
Using the 'in-plane' method parallel to the ultrasound probe, a negative aspiration will be performed, and a total of 20 mL 0.25% bupivacaine will be injected. The distribution of local anesthetic (LA) will be monitored with ultrasound during the injection. The procedure will be applied unilaterally. Post-desufflation, patients will receive 50 mg dexketoprofen intravenously as standard analgesia.
In Group K, 50 mg dexketoprofen intravenous NSAID will be administered as standard analgesia, serving as the control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP M | – | –In patients undergoing elective Laparoscopic Cholecystectomy Surgery, after routine anesthesia induction, a magnesium loading dose of 30 mg/kg will be administered intravenously. Subsequently, a magnesium infusion will be initiated at a rate of 10 mg/kg/hour. Afterward, in the supine position, necessary field preparation and ultrasound (USG) setup will be conducted to administer the External Oblique Intercostal Plane (EOIP) block.The procedure will be applied unilaterally. After desufflation, patients will receive 50 mg dexketoprofen as standard analgesia administered intravenously as a non-steroidal anti-inflammatory drug (NSAID). |
| GROUP K | – | –As part of standard analgesia, 50 mg dexketoprofen, administered intravenously as a non-steroidal anti-inflammatory drug (NSAID), will be applied, and these patients will be considered as the control group. All patients will undergo general anesthesia induction with 1 µg/kg fentanyl, 2-3 mg/kg propofol, and 0.6 mg/kg rocuronium bromide. During anesthesia maintenance, a mixture of 50% O2 and air will be administered, and sevoflurane will be used at a minimum alveolar concentration of 0.8 (with a target MAC value of 0.8-1.2). Additionally, remifentanil will be administered at a rate of 0.01-0.2 mcg/kg/min. The remifentanil dose range will be increased if the patient\'s Nociceptive Level (NOL) value remains elevated for 2 minutes when it exceeds 25. BIS monitoring will be performed for all patients, and the BIS value will be maintained between 40-50. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective laparoscopic cholecystectomy.
Key inclusion criteria (6 listed)
- Individuals aged between 18 and 65 years old
- Those undergoing elective laparoscopic cholecystectomy
- Patients with ASA risk scores of I and II
- Body Mass Index (BMI) < 35 kg/m2
- Patients who have provided informed consent before the procedure
Key exclusion criteria (13 listed)
- Patients under 18 years of age and those over 65 years of age
- Individuals with an ASA score of III or higher
- Cases with a surgical duration of less than 60 minutes
- Emergency surgeries
- Those with a history of abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in Multimodal Analgesia on the Nociceptive Level İndex(NOL)
Time frame: during surgery time
The NOL index is a single number between 0 and 100. A NOL between 0 and 25 represents a physiologically suppressed response adequately inhibiting harmful stimuli, indicating sufficient analgesia. A NOL index greater than 25 (continuous or fluctuating) for multiple minutes signifies the patient is perceiving pain. Higher values indicate a stronger nociceptive response. An index consistently below 10 for more than a minute may suggest excessive anti-nociception, prompting consideration for reducing analgesics. If regional analgesia is employed, lower NOL values are anticipated. The dosage of remifentanil will be increased if the patient's NOL value remains elevated for 2 minutes when it surpasses 25.The number of changes in Ultiva dosage, NOL values will be recorded before intubation, after intubation, during thoracic entry, and during inflation and deflation, as well as at the time of extubation.
2 secondary outcomes
Change From Baseline in Postoperative Recovery Scores on the Visual Analog Scale at Postoperative 30 Minutes
Time frame: postoperative 30 minute
The intensity of nausea and vomiting
Time frame: postoperative 30 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Kehlet, H., et al., A procedure-specific systematic review and consensus recommendations for postoperative analgesia following laparoscopic cholecystectomy. Surg Endosc, 2005. 19(10): p. 1396-415.Link provided by the sponsor.
- Tulgar, S., O. Selvi, and M.S. Kapakli, Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol, 2018. 2018: p. 3947281.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
AYÇA TUBA DUMANLI ÖZCAN principal investigator
ANKARA BİLKENT CİTY HOSPİTAL
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Analgesia, run by Ankara City Hospital Bilkent.
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 6 inclusion and 13 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 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 AYÇA TUBA DUMANLI ÖZCAN (+905057154125, draycaozcan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Multimodal Analgesia on the Nociceptive Level İndex(NOL) (time frame: during surgery time). 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 2 Feb 2024.