Postoperative Pain ManagementAdjuvantQLBNCT06028061
Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant
A study testing Adjuvant-free Quadratus lumborum block and Quadratus lumborum block III with Adjuvant in people with Postoperative Pain Management and Postoperative Pain, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
İn recent years abdominal wall blocks are widely used for to reduce intraoperative anesthetic recuirements and postoperative analgesia.Quadratus lumborum blocks are one of the abdominal wall blocks to used at laparoscopic cholecystectomy.Conventionally adjuvants used to improve and prolonged the effect of periferic… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Management, Postoperative Pain, Analgesia
- What is being tested?
- Adjuvant-free Quadratus lumborum block and Quadratus lumborum block III with Adjuvant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 15 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- American Society of Anesthesiologists physical statusⅠ-II
Who cannot join
- local anesthetic allergy
- Infection at the procedure site Body Mass Index >35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders Contraindications to regional anesthesia several lung and heart disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Education Hospital
Istanbul, Marmara, 34255
About this study
Official title: Evaluation of The Postoperative Analgesic Effectivity of Quadratus Lumborum Block III With Adjuvant on Patients Undergoing Laparoscopic Cholecystectomy Surgery : A Randomised Controled Study
İn recent years abdominal wall blocks are widely used for to reduce intraoperative anesthetic recuirements and postoperative analgesia.Quadratus lumborum blocks are one of the abdominal wall blocks to used at laparoscopic cholecystectomy.Conventionally adjuvants used to improve and prolonged the effect of periferic nerve, spinal and abdominal blocks.İn this study investigators will evaluate the effectiveness of adjuvants at quatratus lumborum block at patient underwent laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum III block is a regional technique performed for multimodal analgesia.Adjuvants are known to improve the analgesic efficacy and prolonge the effect of the periferic and central nerve blocks.The aim of this study is to determine the effectiveness of adding adjuvant at quadratus lumborum block for patients who underwent laparoscopic cholecystectomy.
- Conditions
- Postoperative Pain Management, Postoperative Pain, Analgesia, Nerve Blocks, Nerve Block Duration, Cholecystectomy
- Being tested
- Adjuvant-free Quadratus lumborum block, Quadratus lumborum block III with Adjuvant
- Keywords
- postoperative pain, laparoscopic cholecystectomy, quadratus lumborum block, abdominal wall blocks, adjuvant, dexamethasone, postoperative analgesia
- 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.
Adjuvant-free Quadratus lumborum blockProcedure or surgery
Also called only bupivacain, adjuvan-free
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
Quadratus lumborum block III with AdjuvantProcedure or surgery
Also called bupivacain with dexamethasone
The same block was applied to this group too, but a different local anesthetic mixture was used.Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant-free Quadratus lumborum block | Active comparator | Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side. Receives: Procedure: Adjuvant-free Quadratus lumborum block |
| Quadratus Lumborum Block with adjuvant | Active comparator | The same block was applied to this group, but a different local anesthetic mixture was used. Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side. Receives: Procedure: Quadratus lumborum block III with Adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of opioid requirements
The total tramadol use of the patients in 24 hours will be recorded.
Measured: within 24 hours after the surgery
rescue analgesia
The rescue analgesia requirement and time of the need of the rescue analgesia requirement
Measured: within 24 hours after the surgery
Secondary outcomes (3)
intraoperative remifentanil consumption
The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
Measured: during operation procedure]
Visual Analogue Scale values
Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
Measured: at 1st, 4th,8th 12th and 24th hours after the surgery]
side effects such as nausea, vomiting and shoulder pain
The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.
Measured: within 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Sep 2023
- Primary completion15 Dec 2023
- Study completion15 Feb 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 Postoperative Pain ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SERPİL ŞEHİRLİOĞLU, Gaziosmanpasa Research and Education Hospital
- Investigators
- SERPİL SEHİRLİOGLU, MD, Principal investigator, Gaziosmanpasa Research and Education HospitalBATUHAN BURHAN, MD, Principal investigator, Gaziosmanpasa Research and Education HospitalDONDU GENC MORALAR, MD, Study director, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028061
- Sponsor's protocol ID
- GaziosmanpasaTREHBB
- Acronym
- AdjuvantQLB
- Status last verified
- Oct 2024
- First submitted
- 31 Aug 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Wang YP, Wang HT, Xu YC, Lv HM, Yu Y, Wang P, Pei XD, Zhao JW, Nan ZH, Yang JJ. Ultrasound-guided quadratus lumborum block provided more effective analgesia for children undergoing lower abdominal laparoscopic surgery: a randomized clinical trial. Surg Endosc. 2022 Dec;36(12):9046-9053. doi: 10.1007/s00464-022-09370-z. Epub 2022 Jun 28.
PubMed 35764836Aygun H, Kavrut Ozturk N, Pamukcu AS, Inal A, Kiziloglu I, Thomas DT, Tulgar S, Nart A. Comparison of ultrasound guided Erector Spinae Plane Block and quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy patients; a prospective randomized study. J Clin Anesth. 2020 Jun;62:109696. doi: 10.1016/j.jclinane.2019.109696. Epub 2019 Dec 18.
PubMed 31862217Herman JA, Urits I, Kaye AD, Urman RD, Viswanath O. Erector Spinae Plane Block (ESPB) or Quadratus Lumborum Block (QLB-II) for laparoscopic cholecystectomy: Impact on postoperative analgesia. J Clin Anesth. 2020 Nov;66:109958. doi: 10.1016/j.jclinane.2020.109958. Epub 2020 Jun 17. No abstract available.
PubMed 32563073Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.
PubMed 36288584
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Postoperative Analgesic Effectivity of Quadratus Lumborum Block III With Adjuvant on Patients Undergoing Laparoscopic Cholecystectomy Surgery : A Randomised Controled Study
- ClinicalTrials.gov ID
- NCT06028061
- Acronym / sponsor ID
- AdjuvantQLB / GaziosmanpasaTREHBB
- Conditions
- Postoperative Pain Management, Postoperative Pain, Analgesia, Nerve Blocks, Nerve Block Duration, Cholecystectomy
- Keywords
- postoperative pain, laparoscopic cholecystectomy, quadratus lumborum block, abdominal wall blocks, adjuvant, dexamethasone, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 7 Sep 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.
İn recent years abdominal wall blocks are widely used for to reduce intraoperative anesthetic recuirements and postoperative analgesia.Quadratus lumborum blocks are one of the abdominal wall blocks to used at laparoscopic cholecystectomy.Conventionally adjuvants used to improve and prolonged the effect of periferic nerve, spinal and abdominal blocks.İn this study investigators will evaluate the effectiveness of adjuvants at quatratus lumborum block at patient underwent laparoscopic cholecystectomy.
Detailed description
Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum III block is a regional technique performed for multimodal analgesia.Adjuvants are known to improve the analgesic efficacy and prolonge the effect of the periferic and central nerve blocks.The aim of this study is to determine the effectiveness of adding adjuvant at quadratus lumborum block for patients who underwent laparoscopic cholecystectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant-free Quadratus lumborum block | Active comparator | Procedure: Adjuvant-free Quadratus lumborum blockPatients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side. |
| Quadratus Lumborum Block with adjuvant | Active comparator | Procedure: Quadratus lumborum block III with AdjuvantThe same block was applied to this group, but a different local anesthetic mixture was used. Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years of age
- American Society of Anesthesiologists physical statusⅠ-II
Key exclusion criteria (2 listed)
- local anesthetic allergy
- Infection at the procedure site Body Mass Index >35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders Contraindications to regional anesthesia several lung and heart disease
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 |
|---|---|---|
| Adjuvant-free Quadratus lumborum blockAlso: only bupivacain, adjuvan-freePatients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side. | Procedure or surgery | Adjuvant-free Quadratus lumborum block |
| Quadratus lumborum block III with AdjuvantAlso: bupivacain with dexamethasoneThe same block was applied to this group too, but a different local anesthetic mixture was used.Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side. | Procedure or surgery | Quadratus Lumborum Block with adjuvant |
Primary outcome
Total amount of opioid requirements
Time frame: within 24 hours after the surgery
The total tramadol use of the patients in 24 hours will be recorded.
rescue analgesia
Time frame: within 24 hours after the surgery
The rescue analgesia requirement and time of the need of the rescue analgesia requirement
3 secondary outcomes
intraoperative remifentanil consumption
Time frame: during operation procedure]
Visual Analogue Scale values
Time frame: at 1st, 4th,8th 12th and 24th hours after the surgery]
side effects such as nausea, vomiting and shoulder pain
Time frame: within 24 hours after the 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 29 Oct 2024.
- Background: PubMed 35764836Zhang Y, Wang YP, Wang HT, Xu YC, Lv HM, Yu Y, Wang P, Pei XD, Zhao JW, Nan ZH, Yang JJ. Ultrasound-guided quadratus lumborum block provided more effective analgesia for children undergoing lower abdominal laparoscopic surgery: a randomized clinical trial. Surg Endosc. 2022 Dec;36(12):9046-9053. doi: 10.1007/s00464-022-09370-z. Epub 2022 Jun 28.
- Background: PubMed 31862217Aygun H, Kavrut Ozturk N, Pamukcu AS, Inal A, Kiziloglu I, Thomas DT, Tulgar S, Nart A. Comparison of ultrasound guided Erector Spinae Plane Block and quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy patients; a prospective randomized study. J Clin Anesth. 2020 Jun;62:109696. doi: 10.1016/j.jclinane.2019.109696. Epub 2019 Dec 18.
- Background: PubMed 32563073Herman JA, Urits I, Kaye AD, Urman RD, Viswanath O. Erector Spinae Plane Block (ESPB) or Quadratus Lumborum Block (QLB-II) for laparoscopic cholecystectomy: Impact on postoperative analgesia. J Clin Anesth. 2020 Nov;66:109958. doi: 10.1016/j.jclinane.2020.109958. Epub 2020 Jun 17. No abstract available.
- Background: PubMed 36288584Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.
- 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.
SERPİL SEHİRLİOGLU, MD principal investigator
Gaziosmanpasa Research and Education Hospital
BATUHAN BURHAN, MD principal investigator
Gaziosmanpasa Research and Education Hospital
DONDU GENC MORALAR, MD study director
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjuvant-free Quadratus lumborum block and Quadratus lumborum block III with Adjuvant in people with Postoperative Pain Management and Postoperative Pain, run by Gaziosmanpasa Research and Education Hospital 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 2 inclusion and 2 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 29 Oct 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?
Total amount of opioid requirements (time frame: within 24 hours after the surgery). 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 NCT06028061, 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 29 Oct 2024.