Postoperative PainNCT06253208
Laparoscopic Versus Ultrasound Guided Block in Sleeve Gastrectomy
An observational study of Postoperative Pain, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of pain conditions in the first 24 hours after surgery in terms of two different analgesia methods Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- postoperative pain
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 24 Jun 2024
- 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: 50 patients over the age of 18 who will undergo laparoscopic sleeve gastrectomy will be included in the study.
Who may be able to join
- Patients who can tolerate general anesthesia and pneumoperitoneum.
- Patients who can give informed consent for surgery.
- Patients over 18 years of age
- patients with body mass index (BMI) > 30 kg/m2
- Patients with American Society of Anesthesiologists (ASA) physical status I and II
Who cannot join
- Patients allergic to local anesthetics.
- Patients with serious underlying cardiovascular disease (e.g. congestive heart failure, conduction disorders and ischemic heart disease).
- Patients with chronic kidney disease stage 3 or greater (creatinine clearance less than 60 mL/min).
- Patients who have had previous abdominal surgery, including resection of the esophagus, stomach, liver and pancreas.
- Patients with chronic pain and chronic opioid use
- Patients with ASA class IV
Show all 9Show fewer
- patients with psychiatric disorders
- pregnant or breastfeeding patients
- patients with a history of seizures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istinye University
Istanbul
ilke dolgun
About this study
Official title: Postoperative Analgesia in Laparoscopic Sleeve Gastrectomies: Laparoscopic Versus Ultrasound-guided Transversus Abdominis Plane Block
Comparison of pain conditions in the first 24 hours after surgery in terms of two different analgesia methods
Read the detailed description
Introduction and purpose:
Morbid obesity (MO) is a disease that has become a worldwide epidemic, and in the last three decades, the average body mass index (BMI) has increased by 0.4 kg/m2 per decade worldwide. Parallel to this situation, the number of obesity surgery operations is increasing steadily. In 2017, this number reached 228,000 surgeries in the United States. In particular, due to its technical simplicity and positive outcomes, laparoscopic sleeve gastrectomy (LSG) has become the dominant bariatric operation, accounting for approximately 60% of all bariatric procedures (1) These individuals are at high risk for postoperative adverse respiratory events, nosocomial infections, cardiovascular complications, and pulmonary embolism (the second leading cause of death in the bariatric surgery population). Therefore, given the increasing number of patients living with obesity and seeking elective weight loss surgery, it is crucial to understand and optimize the analgesic requirements of this patient population. However, no ideal analgesic regimen exists for this patient population and limited evidence-based recommendations (2) Pain management of the MO patient is an evolving issue and remains extremely important in terms of patient safety and possible addiction risk. Effective postoperative pain management is crucial to encouraging early walking and deep breathing, which are known to reduce the risk of complications. Multimodal analgesia has been advocated by many authors as part of Enhanced Recovery After Surgery (ERAS) programs to reduce the incidence and severity of postoperative pain (3).
Similar to the increase in the number of MOs over the past three decades, opioid use has also increased dramatically. In the United States, opioid overdose has become the leading cause of unintentional death, surpassing motor vehicle crashes. Frequently, the first exposure to opioids may occur during the perioperative period of an elective surgery. It has been reported that approximately 6-8% of opioid-naïve patients undergoing non-cancer procedures develop new persistent opioid use (1). Increased opiate use is associated with increased rates of delirium, ileus, urinary retention, and respiratory depression and may have strong addictive potential. Opioid-induced cardiopulmonary arrest usually occurs within the first 24 hours of surgery (3). Therefore, the surgical team has a critical role in patient management in terms of opioid-independent analgesia control.
To optimize pain control, multimodal anesthesia and regional analgesia have become key components of improved clinical recovery pathways and therefore recommended methods for perioperative pain control. One of these is the transversus abdominis plane (TAP) block, whose effectiveness has been proven in this patient group.
TAP blocks are widely used for intraoperative and postoperative analgesia in various abdominal and gynecological surgeries. There is evidence in the literature that TAP blocks are beneficial in laparoscopic (minimally invasive) surgeries such as laparoscopic cholecystectomy, hernia repair and laparoscopic colorectal resection (4-8). Similarly, in two of the studies demonstrating the feasibility of TAP blocks in laparoscopic bariatric surgery (9,10), it was shown that there was a decrease in pain scores and in another (9) it was shown that it reduced opioid consumption.
Traditionally, the TAP block is completed by an anesthesiologist at the beginning or end of surgery, using ultrasound guidance to improve the accuracy of visualization of the target anatomy and the spread of local anesthesia within the application area (US-TAP). However, in recent years, a new technique has been developed and started to be used during laparoscopic surgery, in which the surgeon can perform the TAP block under direct visualization: laparoscopy-guided TAP block (L-TAP). Numerous studies and technical reports describe this laparoscopic-assisted technique. Studies have shown that laparoscopic-assisted TAP blocks result in similar pain scores and postoperative opioid consumption but lead to shorter block performance time compared to ultrasound-guided block (11). Additionally, a statistically significant decrease was observed in the pain scores and opioid consumption of patients receiving laparoscopic-assisted TAP block compared to controls (12,13). Similarly, in a meta-analysis, it was stated that L-TAP provided comparable analgesia to US-TAP, and there was no statistically significant difference in pain scores at different times and during both rest and movement (14). According to the same meta-analysis, patients in most studies achieved adequate pain control, and 24-hour opioid consumption, incidence of postoperative nausea and vomiting, functional recovery, bowel function, and hospital stay rates did not differ significantly between the 2 methods.
- Conditions
- Postoperative Pain
- Being tested
- postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative painProcedure or surgery
Postoperative analgesia in laparoscopic sleeve gastrectomies: laparoscopic versus ultrasound-guided transversus abdominis plane block
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic block | laparoscopic transversus abdominis plane block Receives: Procedure: postoperative pain | |
| ultrasound guided block | ultrasound guided transversus abdominis plane block Receives: Procedure: postoperative pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
postoperative pain
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Jan 2024
- Primary completion24 Apr 2024 (estimated)
- Study completion24 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Biruni 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilke dolğun, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253208
- Sponsor's protocol ID
- istinye
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okut G, Turgut E, Kaplan K, Bag YM, Akbas S, Sumer F, Kayaalp C. Does laparoscopic-guided transversus abdominis plane block have an effect on postoperative pain and recovery after sleeve gastrectomy? Eur Rev Med Pharmacol Sci. 2022 Aug;26(15):5406-5412. doi: 10.26355/eurrev_202208_29408.
PubMed 35993635Hamid HK, Emile SH, Saber AA, Ruiz-Tovar J, Minas V, Cataldo TE. Laparoscopic-Guided Transversus Abdominis Plane Block for Postoperative Pain Management in Minimally Invasive Surgery: Systematic Review and Meta-Analysis. J Am Coll Surg. 2020 Sep;231(3):376-386.e15. doi: 10.1016/j.jamcollsurg.2020.05.020. Epub 2020 Jun 2.
PubMed 32502615Venkatraman R, Saravanan R, Dhas M, Pushparani A. Comparison of laparoscopy-guided with ultrasound-guided subcostal transversus abdominis plane block in laparoscopic cholecystectomy - A prospective, randomised study. Indian J Anaesth. 2020 Dec;64(12):1012-1017. doi: 10.4103/ija.IJA_528_20. Epub 2020 Dec 12.
PubMed 33542563
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia in Laparoscopic Sleeve Gastrectomies: Laparoscopic Versus Ultrasound-guided Transversus Abdominis Plane Block
- ClinicalTrials.gov ID
- NCT06253208
- Acronym / sponsor ID
- istinye
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 24 Apr 2024 (estimated)
- Study completion
- 24 Jun 2024 (estimated)
- First posted
- 12 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.
Comparison of pain conditions in the first 24 hours after surgery in terms of two different analgesia methods
Detailed description
Introduction and purpose:
Morbid obesity (MO) is a disease that has become a worldwide epidemic, and in the last three decades, the average body mass index (BMI) has increased by 0.4 kg/m2 per decade worldwide. Parallel to this situation, the number of obesity surgery operations is increasing steadily. In 2017, this number reached 228,000 surgeries in the United States. In particular, due to its technical simplicity and positive outcomes, laparoscopic sleeve gastrectomy (LSG) has become the dominant bariatric operation, accounting for approximately 60% of all bariatric procedures (1) These individuals are at high risk for postoperative adverse respiratory events, nosocomial infections, cardiovascular complications, and pulmonary embolism (the second leading cause of death in the bariatric surgery population). Therefore, given the increasing number of patients living with obesity and seeking elective weight loss surgery, it is crucial to understand and optimize the analgesic requirements of this patient population. However, no ideal analgesic regimen exists for this patient population and limited evidence-based recommendations (2) Pain management of the MO patient is an evolving issue and remains extremely important in terms of patient safety and possible addiction risk. Effective postoperative pain management is crucial to encouraging early walking and deep breathing, which are known to reduce the risk of complications. Multimodal analgesia has been advocated by many authors as part of Enhanced Recovery After Surgery (ERAS) programs to reduce the incidence and severity of postoperative pain (3).
Similar to the increase in the number of MOs over the past three decades, opioid use has also increased dramatically. In the United States, opioid overdose has become the leading cause of unintentional death, surpassing motor vehicle crashes. Frequently, the first exposure to opioids may occur during the perioperative period of an elective surgery. It has been reported that approximately 6-8% of opioid-naïve patients undergoing non-cancer procedures develop new persistent opioid use (1). Increased opiate use is associated with increased rates of delirium, ileus, urinary retention, and respiratory depression and may have strong addictive potential. Opioid-induced cardiopulmonary arrest usually occurs within the first 24 hours of surgery (3). Therefore, the surgical team has a critical role in patient management in terms of opioid-independent analgesia control.
To optimize pain control, multimodal anesthesia and regional analgesia have become key components of improved clinical recovery pathways and therefore recommended methods for perioperative pain control. One of these is the transversus abdominis plane (TAP) block, whose effectiveness has been proven in this patient group.
TAP blocks are widely used for intraoperative and postoperative analgesia in various abdominal and gynecological surgeries. There is evidence in the literature that TAP blocks are beneficial in laparoscopic (minimally invasive) surgeries such as laparoscopic cholecystectomy, hernia repair and laparoscopic colorectal resection (4-8). Similarly, in two of the studies demonstrating the feasibility of TAP blocks in laparoscopic bariatric surgery (9,10), it was shown that there was a decrease in pain scores and in another (9) it was shown that it reduced opioid consumption.
Traditionally, the TAP block is completed by an anesthesiologist at the beginning or end of surgery, using ultrasound guidance to improve the accuracy of visualization of the target anatomy and the spread of local anesthesia within the application area (US-TAP). However, in recent years, a new technique has been developed and started to be used during laparoscopic surgery, in which the surgeon can perform the TAP block under direct visualization: laparoscopy-guided TAP block (L-TAP). Numerous studies and technical reports describe this laparoscopic-assisted technique. Studies have shown that laparoscopic-assisted TAP blocks result in similar pain scores and postoperative opioid consumption but lead to shorter block performance time compared to ultrasound-guided block (11). Additionally, a statistically significant decrease was observed in the pain scores and opioid consumption of patients receiving laparoscopic-assisted TAP block compared to controls (12,13). Similarly, in a meta-analysis, it was stated that L-TAP provided comparable analgesia to US-TAP, and there was no statistically significant difference in pain scores at different times and during both rest and movement (14). According to the same meta-analysis, patients in most studies achieved adequate pain control, and 24-hour opioid consumption, incidence of postoperative nausea and vomiting, functional recovery, bowel function, and hospital stay rates did not differ significantly between the 2 methods.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic block | – | Procedure: postoperative painlaparoscopic transversus abdominis plane block |
| ultrasound guided block | – | Procedure: postoperative painultrasound guided transversus abdominis plane block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients over the age of 18 who will undergo laparoscopic sleeve gastrectomy will be included in the study.
Key inclusion criteria (5 listed)
- Patients who can tolerate general anesthesia and pneumoperitoneum.
- Patients who can give informed consent for surgery.
- Patients over 18 years of age
- patients with body mass index (BMI) > 30 kg/m2
- Patients with American Society of Anesthesiologists (ASA) physical status I and II
Key exclusion criteria (9 listed)
- Patients allergic to local anesthetics.
- Patients with serious underlying cardiovascular disease (e.g. congestive heart failure, conduction disorders and ischemic heart disease).
- Patients with chronic kidney disease stage 3 or greater (creatinine clearance less than 60 mL/min).
- Patients who have had previous abdominal surgery, including resection of the esophagus, stomach, liver and pancreas.
- Patients with chronic pain and chronic opioid use
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 |
|---|---|---|
| postoperative painPostoperative analgesia in laparoscopic sleeve gastrectomies: laparoscopic versus ultrasound-guided transversus abdominis plane block | Procedure or surgery | laparoscopic block, ultrasound guided block |
Primary outcome
postoperative pain
Time frame: 4 month
postoperative pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Results publication: PubMed 35993635Okut G, Turgut E, Kaplan K, Bag YM, Akbas S, Sumer F, Kayaalp C. Does laparoscopic-guided transversus abdominis plane block have an effect on postoperative pain and recovery after sleeve gastrectomy? Eur Rev Med Pharmacol Sci. 2022 Aug;26(15):5406-5412. doi: 10.26355/eurrev_202208_29408.
- Results publication: PubMed 32502615Hamid HK, Emile SH, Saber AA, Ruiz-Tovar J, Minas V, Cataldo TE. Laparoscopic-Guided Transversus Abdominis Plane Block for Postoperative Pain Management in Minimally Invasive Surgery: Systematic Review and Meta-Analysis. J Am Coll Surg. 2020 Sep;231(3):376-386.e15. doi: 10.1016/j.jamcollsurg.2020.05.020. Epub 2020 Jun 2.
- Results publication: PubMed 33542563Venkatraman R, Saravanan R, Dhas M, Pushparani A. Comparison of laparoscopy-guided with ultrasound-guided subcostal transversus abdominis plane block in laparoscopic cholecystectomy - A prospective, randomised study. Indian J Anaesth. 2020 Dec;64(12):1012-1017. doi: 10.4103/ija.IJA_528_20. Epub 2020 Dec 12.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Biruni 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 5 inclusion and 9 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 12 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 4 month). 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 NCT06253208, which also lists 3 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 12 Feb 2024.