AnesthesiaNCT05822479
Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block
A study testing Bilateral ultrasound guided external oblique intercostal block (EOIB) in people with Anesthesia and Regional Anesthesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In obese patients, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea, vomiting, and analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Regional Anesthesia, Morbid Obesity
- What is being tested?
- Bilateral ultrasound guided external oblique intercostal block (EOIB)
- 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 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 30 May 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between18-65 years
- American Society of Anesthesiology score II-III
- Body mass index (BMI) > 35 kg/m2
- Patients who will sign the informed consent form
Who cannot join
- Patients with drug allergies (Opioids, NSAIDs, local anesthetics)
- Patients with neuro-psychiatric disease, cognitive impairment, inability to communicate, or a history of drug addiction
- Presence of any systemic infection or at the injection site
- Patients taking anticoagulants or having any bleeding disorder (Coagulopathy, International Normalized Ratio (INR) value not within normal limits, thrombocytopenia or platelet dysfunction)
- Patients with significant cardiovascular, hepatic, renal or endocrine disorders
- Patients with a history of chronic pain syndromes or receiving chronic pain treatment and a history of opioid use for more than four weeks in the preoperative period
Show all 10Show fewer
- Patients using continuous positive airway pressure device due to obstructive sleep apnea syndrome (OSAS) (symptoms detected by polysomnography and apnea-hypopnea index (AHI) >5/hour)
- Patients with chronic obstructive pulmonary disease
- Patients who need intensive care unit after surgery
- Patients who do not consent/do not want to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis Universitesi
Samsun, Atakum, 55139
About this study
Official title: Bilateral Ultrasound-guided External Oblique Intercostal Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Prospective Randomized Controlled Study
In obese patients, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea, vomiting, and analgesia. This study aimed to evaluate the impact of the external oblique intercostal block postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic sleeve gastrectomy surgery.
Read the detailed description
Adequate pain control in laparoscopic surgeries is associated with reduced postoperative opioid administration, faster mobilization, faster recovery, and shorter hospital stays. Intraoperative nerve blocks using local anesthetics have been shown to improve postoperative pain in various abdominal surgeries, both open and laparoscopic. Laparoscopic bariatric procedures are most often associated with moderate to severe visceral pain from surgical manipulation of the stomach and intestine. Combined regional and general anesthesia reduces surgical stress responses by interrupting pain transmission signals, which facilitates pain control, reduces opioid consumption, and improves patient postoperative satisfaction. Ultrasound-guided fascial plane blocks have been rapidly included in regional anesthesia applications as an alternative to neuraxial techniques in recent years and include injection into a tissue plane to provide analgesia in various anatomical areas. The external oblique intercostal block (EOIB) represents an essential modification of the fascial plane block techniques that can consistently cover the upper lateral abdominal wall. The EOIB block has easily identifiable sonographic points.
The study aims to investigate the effects of the EOIB on postoperative pain in morbidly obese patients who will undergo laparoscopic sleeve gastrectomy by comparing it with the control group. It is seen that there are not enough studies on EOIB in the literature. Our study, which the investigators think will contribute to the literature, was planned as a prospective, randomized, controlled, single-blind, parallel-group study.
Patients will be divided into two groups:
Group EOIB :
A bilateral EOIB (60 ml 0.25% bupivacaine + 1:400.000 adrenaline) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
Group Control:
Patients in this group will not receive any block. IV morphine-PCA will be applied postoperatively for 24 hours.
- Conditions
- Anesthesia, Regional Anesthesia, Morbid Obesity, Postoperative Pain
- Being tested
- Bilateral ultrasound guided external oblique intercostal block (EOIB), Control
- Keywords
- Anesthesia, Nerve block, Obesity, Laparoscopy, External oblique intercostal block
- Medical subject headings
- Obesity, Morbid, Pain, Postoperative, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral ultrasound guided external oblique intercostal block (EOIB)Procedure or surgery
Also called External oblique intercostal block
Bilateral ultrasound-guided EOIB (total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA
Multimodal analgesia :
Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, iv paracetamol 1 gr and iv morphine 0.05 mg/kg/ideal body weight (IBW) will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). Rescue analgesia, when necessary (if the resting NRS score is ≥4 despite PCA demand), 25 mg IV meperidine was administered in the recovery unit, and 50 mg intramuscular (IM) meperidine was administered in the ward.
ControlOther
Patients in this group will not be performed interfacial plane blocks.
Multimodal analgesia :
Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, iv paracetamol 1 gr and iv morphine 0.05 mg/kg/ideal body weight (IBW) will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). Rescue analgesia, when necessary (if the resting NRS score is ≥4 despite PCA demand), 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.
| Study group | Role | What they receive |
|---|---|---|
| Group EOIB | Active comparator | A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA) Receives: Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB) |
| Group Control | Other | IV morphine PCA Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption in the first 24 hours after surgery
Cumulative opioid consumption in the first 24 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is ≥4. In cases where rescue analgesia is required (NRS score ≥4), 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.
Measured: postoperative day 1
Secondary outcomes (10)
Cumulative opioid consumption in the first 12 hours after surgery
Cumulative opioid consumption in the first 12 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is ≥4 and 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.
Measured: postoperative day 1
Postoperative pain scores
Pain status at rest and while activity will be assessed by NRS score at 0, 3, 6, 12, 18, and 24 hours after surgery. The NRS is an 11-point numeric scale that ranges from 0 to 10.
Measured: postoperative day 1
Patients' satisfaction and quality of pain management
Patients' pain management satisfaction and quality will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) -Turkish Version.
Measured: postoperative day 1
The scores of postoperative nausea and vomiting (PONV) and the number of patients requiring postoperative antiemetics.
The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. For PONV prophylaxis, patients will be routinely administered 8 mg IV dexamethasone before induction and 0.15 mg/kg (IVA) IV ondansetron 20 minutes before the end of the procedure. If a score of 3 or more is recorded, 4 mg IV ondansetron will be administered and repeated after 4 hours if required. Despite the administration of ondansetron, if the score is ≥3, the patients will be administered 10 mg IV metoclopramide diluted in 100 ml saline solution as an IV infusion. The number of patients who receive antiemetic treatment will be recorded. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
Measured: postoperative day 1
The number of patients who required rescue analgesia.
The number of patients requiring rescue analgesics will be recorded over 24 hours.
Measured: postoperative day 1
Time of first analgesic request
Time at which the first analgesic is requested
Measured: postoperative day 1
Intraoperative remifentanil consumption
The total amount of remifentanil consumed will be recorded.
Measured: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.
The number of patients with complications
The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded
Measured: Postoperative 7 days on an average
The heart rate measurement
The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.
Measured: The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.
The mean arterial pressure measurement
The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.
Measured: The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start20 Apr 2023
- Primary completion20 Dec 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengiz KAYA, Ondokuz Mayıs University
- Investigators
- Cengiz KAYA, Study director, Ondokuz Mayıs University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822479
- Sponsor's protocol ID
- EOIB2022
- Status last verified
- May 2024
- First submitted
- 10 Apr 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saber AA, Lee YC, Chandrasekaran A, Olivia N, Asarian A, Al-Ayoubi S, DiGregorio R. Efficacy of transversus abdominis plane (TAP) block in pain management after laparoscopic sleeve gastrectomy (LSG): A double-blind randomized controlled trial. Am J Surg. 2019 Jan;217(1):126-132. doi: 10.1016/j.amjsurg.2018.07.010. Epub 2018 Aug 1.
PubMed 30170687Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
PubMed 34626112White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.
PubMed 35249704Coskun M, Yardimci S, Arslantas MK, Altun GT, Uprak TK, Kara YB, Cingi A. Subcostal Transversus Abdominis Plane Block for Laparoscopic Sleeve Gastrectomy, Is It Worth the Time? Obes Surg. 2019 Oct;29(10):3188-3194. doi: 10.1007/s11695-019-03984-4.
PubMed 31175560
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Ultrasound-guided External Oblique Intercostal Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05822479
- Acronym / sponsor ID
- EOIB2022
- Conditions
- Anesthesia, Regional Anesthesia, Morbid Obesity, Postoperative Pain
- Keywords
- Anesthesia, Nerve block, Obesity, Laparoscopy, External oblique intercostal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 20 Apr 2023 (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.
In obese patients, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea, vomiting, and analgesia. This study aimed to evaluate the impact of the external oblique intercostal block postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic sleeve gastrectomy surgery.
Detailed description
Adequate pain control in laparoscopic surgeries is associated with reduced postoperative opioid administration, faster mobilization, faster recovery, and shorter hospital stays. Intraoperative nerve blocks using local anesthetics have been shown to improve postoperative pain in various abdominal surgeries, both open and laparoscopic. Laparoscopic bariatric procedures are most often associated with moderate to severe visceral pain from surgical manipulation of the stomach and intestine. Combined regional and general anesthesia reduces surgical stress responses by interrupting pain transmission signals, which facilitates pain control, reduces opioid consumption, and improves patient postoperative satisfaction. Ultrasound-guided fascial plane blocks have been rapidly included in regional anesthesia applications as an alternative to neuraxial techniques in recent years and include injection into a tissue plane to provide analgesia in various anatomical areas. The external oblique intercostal block (EOIB) represents an essential modification of the fascial plane block techniques that can consistently cover the upper lateral abdominal wall. The EOIB block has easily identifiable sonographic points.
The study aims to investigate the effects of the EOIB on postoperative pain in morbidly obese patients who will undergo laparoscopic sleeve gastrectomy by comparing it with the control group. It is seen that there are not enough studies on EOIB in the literature. Our study, which the investigators think will contribute to the literature, was planned as a prospective, randomized, controlled, single-blind, parallel-group study.
Patients will be divided into two groups:
Group EOIB :
A bilateral EOIB (60 ml 0.25% bupivacaine + 1:400.000 adrenaline) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
Group Control:
Patients in this group will not receive any block. IV morphine-PCA will be applied postoperatively for 24 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'.
| Arm | Type | Receives |
|---|---|---|
| Group EOIB | Active comparator | Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB)A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA) |
| Group Control | Other | Other: ControlIV morphine PCA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between18-65 years
- American Society of Anesthesiology score II-III
- Body mass index (BMI) > 35 kg/m2
- Patients who will sign the informed consent form
Key exclusion criteria (10 listed)
- Patients with drug allergies (Opioids, NSAIDs, local anesthetics)
- Patients with neuro-psychiatric disease, cognitive impairment, inability to communicate, or a history of drug addiction
- Presence of any systemic infection or at the injection site
- Patients taking anticoagulants or having any bleeding disorder (Coagulopathy, International Normalized Ratio (INR) value not within normal limits, thrombocytopenia or platelet dysfunction)
- Patients with significant cardiovascular, hepatic, renal or endocrine disorders
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 |
|---|---|---|
| Bilateral ultrasound guided external oblique intercostal block (EOIB)Also: External oblique intercostal blockBilateral ultrasound-guided EOIB (total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, iv paracetamol 1 gr and iv morphine 0.05 mg/kg/ideal body weight (IBW) will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). Rescue analgesia, when necessary (if the resting NRS score is ≥4 despite PCA demand), 25 mg IV meperidine was administered in the recovery unit, and 50 mg intramuscular (IM) meperidine was administered in the ward. | Procedure or surgery | Group EOIB |
| ControlPatients in this group will not be performed interfacial plane blocks. Multimodal analgesia : Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, iv paracetamol 1 gr and iv morphine 0.05 mg/kg/ideal body weight (IBW) will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). Rescue analgesia, when necessary (if the resting NRS score is ≥4 despite PCA demand), 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward. | Other | Group Control |
Primary outcome
Cumulative opioid consumption in the first 24 hours after surgery
Time frame: postoperative day 1
Cumulative opioid consumption in the first 24 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is ≥4. In cases where rescue analgesia is required (NRS score ≥4), 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.
10 secondary outcomes
Cumulative opioid consumption in the first 12 hours after surgery
Time frame: postoperative day 1
Postoperative pain scores
Time frame: postoperative day 1
Patients' satisfaction and quality of pain management
Time frame: postoperative day 1
The scores of postoperative nausea and vomiting (PONV) and the number of patients requiring postoperative antiemetics.
Time frame: postoperative day 1
The number of patients who required rescue analgesia.
Time frame: postoperative day 1
Time of first analgesic request
Time frame: postoperative day 1
Intraoperative remifentanil consumption
Time frame: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.
The number of patients with complications
Time frame: Postoperative 7 days on an average
The heart rate measurement
Time frame: The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.
The mean arterial pressure measurement
Time frame: The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.
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 3 Jul 2024.
- Background: PubMed 30170687Saber AA, Lee YC, Chandrasekaran A, Olivia N, Asarian A, Al-Ayoubi S, DiGregorio R. Efficacy of transversus abdominis plane (TAP) block in pain management after laparoscopic sleeve gastrectomy (LSG): A double-blind randomized controlled trial. Am J Surg. 2019 Jan;217(1):126-132. doi: 10.1016/j.amjsurg.2018.07.010. Epub 2018 Aug 1.
- Background: PubMed 34626112Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
- Background: PubMed 35249704White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.
- Background: PubMed 31175560Coskun M, Yardimci S, Arslantas MK, Altun GT, Uprak TK, Kara YB, Cingi A. Subcostal Transversus Abdominis Plane Block for Laparoscopic Sleeve Gastrectomy, Is It Worth the Time? Obes Surg. 2019 Oct;29(10):3188-3194. doi: 10.1007/s11695-019-03984-4.
- 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.
Cengiz KAYA study director
Ondokuz Mayıs University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral ultrasound guided external oblique intercostal block (EOIB) in people with Anesthesia and Regional Anesthesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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 3 Jul 2024. 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 Turkey (Türkiye). 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?
Cumulative opioid consumption in the first 24 hours after surgery (time frame: postoperative day 1). 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 NCT05822479, which also lists 4 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 3 Jul 2024.