- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950502
Comparison of the Effects of Bilateral Transversus Abdominis Plane Block and Bilateral Quadratus Lumborum Block on Postoperative Analgesia in Patients Undergoing Midline Laparotomy
Midline incisions provide easy, rapid and excellent exposure of the abdominal cavity and are particularly used for complex, diagnostic or emergency procedures.
However, midline incisions transect the nerve fibers passing in the mediocaudal direction of the abdominal wall, which causes more postoperative pain than other incisions.
Postoperative pain and delayed return of bowel function are thought to be the main factors that prevent early recovery and discharge.
or surgical procedures where parietal pain is the main component of postoperative pain, TAPB can be used as a simple and effective analgesic technique with the added advantage of preserved motor and bladder function.
Quadratus lumborum block can be used as an analgesic technique in all surgeries such as proctosigmoidectomy, hip surgery, above-knee amputation, abdominal hernia repair, breast reconstruction, colostomy closure, radical nephrectomy, lower extremity vascular surgery, total hip arthroplasty, laparotomy and colectomy.
Our study aimed to compare the effects of bilateral oblique subcostal TAPB with bilateral QLB2 and QLB3 performed under ultrasound guidance in midline incision laparotomies on total opioid requirement in the first 24 hours postoperatively, early postoperative pain intensity, time to first rescue analgesic requirement, nausea, vomiting and pruritus.
To evaluate this hypothesis, we compared TAPB and QLB in a prospective, randomized, single-center clinical study. The primary endpoint of our study was the comparison of total morphine consumption in the first 24 hours postoperatively.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Ankara University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Laparotomy with midline incision
- General anesthesia will be applied
- 18-70 years old
- ASA 1-3
- BMI of 18-30 kg/m2
- Literate
- Without cognitive impairment
- Patients who approved the informed consent form
Exclusion Criteria:
- Under 18 years old
- Over 70 years old
- ASA 4 and above
- Cognitive impairment
- İlliteracy
- Vision and hearing problem
- Infection at the injection site
- Coagulopathy
- Peripheral neuropathy
- Local anesthetic allergy
- Patients who do not want to be included in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Quadratus Lumborum Group (QLB)
Quadratus lumborum block; after the patient was lying in the lateral decubitus position and skin asepsis of the posterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the ultrasound probe was moved from the level of the iliac crest to the 4th lumbar vertebra and the quadratus lumborum muscle was visualized on the transverse process of the 4th lumbar vertebra at the point where the anterior abdominal wall muscles end.
The needle was advanced in-plane between the quadratus lumborum muscle and the erector spinae-latissimus dorsi muscles (QLB2) located on the posterior-superior side of this muscle, and 0.15 ml/kg 0.25% bupivacaine was injected under the thoracolumbar fascia located between these two muscles.
Then, the needle was advanced towards the quadratus lumborum and the psoas major (QLB3) muscle located on the anterior-inferior side, and 0.15 ml/kg 0.25% bupivacaine was injected between these two muscles.This procedure was applied to the patient bilaterally.
|
Quadratus lumborum block; after the patient was lying in the lateral decubitus position and skin asepsis of the posterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the ultrasound probe was moved from the level of the iliac crest to the 4th lumbar vertebra and the quadratus lumborum muscle was visualized on the transverse process of the 4th lumbar vertebra at the point where the anterior abdominal wall muscles end.
The needle was advanced in-plane between the quadratus lumborum muscle and the erector spinae-latissimus dorsi muscles (QLB2) located on the posterior-superior side of this muscle, and 0.15 ml/kg 0.25% bupivacaine was injected under the thoracolumbar fascia located between these two muscles.
Then, the needle was advanced towards the quadratus lumborum and the psoas major (QLB3) muscle located on the anterior-inferior side, and 0.15 ml/kg 0.25% bupivacaine was injected between these two muscles.This procedure was applied to the patient bilaterally.
The needle was advanced in-plane between the quadratus lumborum muscle and the erector spinae-latissimus dorsi muscles (QLB2) located on the posterior-superior side of this muscle, and 0.15 ml/kg 0.25% bupivacaine was injected under the thoracolumbar fascia located between these two muscles.
Then, the needle was advanced towards the quadratus lumborum and the psoas major (QLB3) muscle located on the anterior-inferior side, and 0.15 ml/kg 0.25% bupivacaine was injected between these two muscles.This procedure was applied to the patient bilaterally.
|
|
Active Comparator: Transversus Abdominis Plane Group (TAPB)
Transversus abdominis plane block was performed with the patient lying in the supine position via an oblique subcostal approach from the anterior abdominal wall.
After skin asepsis of the anterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the linear ultrasound probe was placed parallel to the subcostal border at the level of the xiphoid bone and the subcutaneous fat tissue, rectus abdominis muscle and transversus abdominis muscle were visualized, respectively.
A 10 cm 20G needle (BRAUN Stimuplex Ultra 360, GERMANY) was advanced towards the transversus abdominis muscle fascia with the in-plane technique and 0.3 ml/kg 0.25% bupivacaine was injected into this area.This procedure was performed bilaterally.
|
Transversus abdominis plane block was performed with the patient lying in the supine position via an oblique subcostal approach from the anterior abdominal wall.
After skin asepsis of the anterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the linear ultrasound probe was placed parallel to the subcostal border at the level of the xiphoid bone and the subcutaneous fat tissue, rectus abdominis muscle and transversus abdominis muscle were visualized, respectively.
A 10 cm 20G needle (BRAUN Stimuplex Ultra 360, GERMANY) was advanced towards the transversus abdominis muscle fascia with the in-plane technique and 0.3 ml/kg 0.25% bupivacaine was injected into this area.This procedure was performed bilaterally.
A 10 cm 20G needle (BRAUN Stimuplex Ultra 360, GERMANY) was advanced towards the transversus abdominis muscle fascia with the in-plane technique and 0.3 ml/kg 0.25% bupivacaine was injected into this area.This procedure was performed bilaterally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Our study aimed to compare the effects of bilateral oblique subcostal TAPB with bilateral QLB2 and QLB3 performed under ultrasound guidance in midline incision laparotomies on total opioid requirement in the first 24 hours postoperatively
Time Frame: Within 24 hours after surgery
|
All patients were extubated after the block was performed.
All patients were given 1 mg bolus 10 min lock time IV morphine (Morphine Hydrochloride, OSEL Drug) connected to the PCA device (BodyGuard 575i Pain Manager, TARMED).
If the morphine given with the PCA device was not sufficient as an analgesic, patients were given 1 gr IV paracetamol infusion (the dose was adjusted so that the paracetamol dose did not exceed a maximum of 4 grams per day).
If the VAS was still >4 at 1 hour after paracetamol, the patient was administered 50 mg IV dexketoprofen (NSAID) (the dexketoprofen dose was adjusted to a maximum of 150 milligrams per day).he
amount of opioids used and requested by the patients was recorded as the amount of PCA medication at the 15th minute, 2nd, 4th, 8th, 12th, 16th and 24th hours, as how much opioids they requested or used at the specified time intervals.
For example, the amount of opioid used between the 15th minute and the 2nd hour was recorded at the 2nd hour.
|
Within 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Liang SS, Ying AJ, Affan ET, Kakala BF, Strippoli GF, Bullingham A, Currow H, Dunn DW, Yeh ZY. Continuous local anaesthetic wound infusion for postoperative pain after midline laparotomy for colorectal resection in adults. Cochrane Database Syst Rev. 2019 Oct 19;10(10):CD012310. doi: 10.1002/14651858.CD012310.pub2.
- Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.
- Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available. Erratum In: Anesthesiology. 2024 Dec 1;141(6):1226. doi: 10.1097/ALN.0000000000005221.
- Mrunalini P, Raju NV, Nath VN, Saheb SM. Efficacy of transversus abdominis plane block in patients undergoing emergency laparotomies. Anesth Essays Res. 2014 Sep-Dec;8(3):377-82. doi: 10.4103/0259-1162.143153.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EAsik
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quadratus Lumborum Block
-
Tanta UniversityRecruitingQuadratus Lumborum BlockEgypt
-
Assiut UniversityRecruitingQuadratus Lumborum BlockEgypt
-
Ostfold Hospital TrustCompletedQuadratus Lumborum Block | CholecystectomyNorway
-
Alexandria UniversityCompletedTransmuscular Quadratus Lumborum Block Hip SurgeryEgypt
-
Tanta UniversityEnrolling by invitationQuadratus Lumborum Block | Appendectomy | Transversalis Fascia Plane BlockEgypt
-
Ain Shams UniversityRecruitingLaparoscopic Cholecystectomy | Quadratus Lumborum Block | Modified Thoracoabdominal Nerve BlockEgypt
-
Port Said University hospitalCompletedErector Spinae Plane Block | Quadratus Lumborum Block | Sleeve GastrectomyEgypt
-
Zagazig UniversityCompletedLaparoscopic Cholecystectomy | Erector Spinae Plane Block | Quadratus Lumborum BlockEgypt
-
University of California, Los AngelesTerminatedLaparoscopic Myomectomy | Quadratus Lumborum Nerve BlockUnited States
-
Cairo UniversityUnknownQuadratus Lumborum Block | Lower Abdominal SurgeryEgypt
Clinical Trials on Quadratus Lumborum Block (QLB)
-
Ain Shams UniversityActive, not recruiting
-
Zonguldak Bulent Ecevit UniversityCompletedQuadratus Lumborum Block | Opioid Consumption | Perioperative Analgesia | Percutaneous Nephrolithotomy (PCNL)Turkey (Türkiye)
-
Namik Kemal UniversityCompletedBladder Cancer | Postoperative Pain Management | Opioid Consumption | Recovery QualityTurkey
-
Sheikh Khalifa Bin Zayed Al Nahyan Combined Military...Not yet recruitingPost Operative AnalgesiaPakistan
-
Zeycan KahyaCompletedComparison of ESP and QL Blocks for Postoperative Pain in Pediatric Appendectomy (ESP-QLB) (ESP-QLB)Erector Spinae Block | Quadratus Lumborum Nerve BlockTurkey (Türkiye)
-
Tampere University HospitalCompletedPostoperative Pain | Nausea and Vomiting, Postoperative | Chronic Pain Post-ProceduraalFinland
-
University Hospital, MontpellierCompletedPostoperative Pain | Total Hip ReplacementFrance
-
Coombe Women and Infants University HospitalCompletedQuadratus Lumborum BlockIreland
-
Biruni UniversityCompleted
-
Kecioren Education and Training HospitalUnknownPostoperative PainTurkey