Post Operative PainNCT05310266
Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Pain Management in Laparoscopic Appendectomy
A study testing Transversus abdominis plane block and Quadratus Lumborum Block in people with Post Operative Pain and Appendicitis Acute, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic appendectomy causes postoperative pain. The primary objective of this prospective randomized controlled study is to compare the effect of ultrasound (US)-guided quadratus lumborum block (QLB) on 24-hour cumulative opioid requirements with transversus abdominis plane (TAP) block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain, Appendicitis Acute, Surgery
- What is being tested?
- Transversus abdominis plane block and Quadratus Lumborum Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2020to 21 Feb 2022
- 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
- Ages of 18-65
- Patients who will undergo laparoscopic appendectomy
- ASA I-II-III patients
Who cannot join
- Clinically known local anesthetic allergy
- Morbid obesity (body mass index>40 kg m2)
- Clinically diagnosis of opioid, alcohol and substance dependence
- Clinically diagnosis of psychiatric disease
- Coagulopathy
- Patients with ASA IV-V
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Bakirkoy, 34147
About this study
Official title: Ultrasound-guided Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Appendectomy: A Prospective, Randomized, Controlled Clinical Study
Laparoscopic appendectomy causes postoperative pain. The primary objective of this prospective randomized controlled study is to compare the effect of ultrasound (US)-guided quadratus lumborum block (QLB) on 24-hour cumulative opioid requirements with transversus abdominis plane (TAP) block.
Read the detailed description
168 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo laparoscopic appendectomy, were randomized and divided into two groups. 32 patients were dropout for different reasons.(68 patients in each of the TAP block and QLB block groups). TAP block was performed for TAP group and QLB block was performed for QLB group. Postoperative analgesia was provided by intravenous tramadol hydrochloride using a patient-controlled analgesia device. 24-hour total tramadol hydrochloride consumption was primary outcome measure.Postoperative numeric rating scale values were the secondary outcome measure.
- Conditions
- Post Operative Pain, Appendicitis Acute, Surgery
- Being tested
- Transversus abdominis plane block, Quadratus Lumborum Block
- Keywords
- Postoperative pain, Laparoscopic appendectomy, Transversus abdominis plane block, Quadratus Lumborum Block, Local anesthetic
- Medical subject headings
- Pain, Postoperative, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane blockProcedure or surgery
The investigators performed transversus abdominis plane block to that patient group for postoperative analgesia
Quadratus Lumborum BlockProcedure or surgery
The investigators performed quadratus lumborum block to that patient group for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Group TAP | Active comparator | The investigators performed transversus abdominis plane block to that patient group for postoperative analgesia Receives: Procedure: Transversus abdominis plane block |
| Group QLB | Active comparator | The investigators performed quadratus lumborum block to that patient group for postoperative analgesia Receives: Procedure: Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24-hours total tramadol hydrochloride consumption
This will be measured by pca device in the 24 hour after
Measured: 24 hours postoperatively
Secondary outcomes (1)
Numerical rating scale (NRS) scores of patients
Numerical rating scale (NRS) at 1, 6, 12, 18, 24th hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start6 Apr 2020
- Primary completion17 Nov 2021
- Study completion21 Feb 2022
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 Post Operative PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310266
- Sponsor's protocol ID
- 2020-35
- Status last verified
- Jul 2022
- First submitted
- 26 Mar 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available from the publication date can start. NRS scores will be shared. If requested, data will be shared with anesthesiologists dealing with postoperative pain management.
Publications
Tupper-Carey DA, Fathil SM, Tan YK, Kan YM, Cheong CY, Siddiqui FJ, Assam PN. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy. Singapore Med J. 2017 Aug;58(8):481-487. doi: 10.11622/smedj.2016068. Epub 2016 Apr 8.
PubMed 27056207Baytar C, Yilmaz C, Karasu D, Topal S. Comparison of Ultrasound-Guided Subcostal Transversus Abdominis Plane Block and Quadratus Lumborum Block in Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled Clinical Study. Pain Res Manag. 2019 Feb 3;2019:2815301. doi: 10.1155/2019/2815301. eCollection 2019.
PubMed 30863471Saleh AH, Abdallah MW, Mahrous AM, Ali NA. Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double-blinded, controlled trial. Braz J Anesthesiol. 2021 Jul-Aug;71(4):367-375. doi: 10.1016/j.bjane.2021.01.009. Epub 2021 Mar 21.
PubMed 33762197
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Appendectomy: A Prospective, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05310266
- Acronym / sponsor ID
- 2020-35
- Conditions
- Post Operative Pain, Appendicitis Acute, Surgery
- Keywords
- Postoperative pain, Laparoscopic appendectomy, Transversus abdominis plane block, Quadratus Lumborum Block, Local anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 4 Apr 2022 (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.
Laparoscopic appendectomy causes postoperative pain. The primary objective of this prospective randomized controlled study is to compare the effect of ultrasound (US)-guided quadratus lumborum block (QLB) on 24-hour cumulative opioid requirements with transversus abdominis plane (TAP) block.
Detailed description
168 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo laparoscopic appendectomy, were randomized and divided into two groups. 32 patients were dropout for different reasons.(68 patients in each of the TAP block and QLB block groups). TAP block was performed for TAP group and QLB block was performed for QLB group. Postoperative analgesia was provided by intravenous tramadol hydrochloride using a patient-controlled analgesia device. 24-hour total tramadol hydrochloride consumption was primary outcome measure.Postoperative numeric rating scale values were the secondary outcome measure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TAP | Active comparator | Procedure: Transversus abdominis plane blockThe investigators performed transversus abdominis plane block to that patient group for postoperative analgesia |
| Group QLB | Active comparator | Procedure: Quadratus Lumborum BlockThe investigators performed quadratus lumborum block to that patient group for postoperative analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages of 18-65
- Patients who will undergo laparoscopic appendectomy
- ASA I-II-III patients
Key exclusion criteria (6 listed)
- Clinically known local anesthetic allergy
- Morbid obesity (body mass index>40 kg m2)
- Clinically diagnosis of opioid, alcohol and substance dependence
- Clinically diagnosis of psychiatric disease
- Coagulopathy
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 |
|---|---|---|
| Transversus abdominis plane blockThe investigators performed transversus abdominis plane block to that patient group for postoperative analgesia | Procedure or surgery | Group TAP |
| Quadratus Lumborum BlockThe investigators performed quadratus lumborum block to that patient group for postoperative analgesia | Procedure or surgery | Group QLB |
Primary outcome
Postoperative 24-hours total tramadol hydrochloride consumption
Time frame: 24 hours postoperatively
This will be measured by pca device in the 24 hour after
1 secondary outcome
Numerical rating scale (NRS) scores of patients
Time frame: 24 hours postoperatively
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 27 Jul 2022.
- Results publication: PubMed 27056207Tupper-Carey DA, Fathil SM, Tan YK, Kan YM, Cheong CY, Siddiqui FJ, Assam PN. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy. Singapore Med J. 2017 Aug;58(8):481-487. doi: 10.11622/smedj.2016068. Epub 2016 Apr 8.
- Results publication: PubMed 30863471Baytar C, Yilmaz C, Karasu D, Topal S. Comparison of Ultrasound-Guided Subcostal Transversus Abdominis Plane Block and Quadratus Lumborum Block in Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled Clinical Study. Pain Res Manag. 2019 Feb 3;2019:2815301. doi: 10.1155/2019/2815301. eCollection 2019.
- Results publication: PubMed 33762197Saleh AH, Abdallah MW, Mahrous AM, Ali NA. Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double-blinded, controlled trial. Braz J Anesthesiol. 2021 Jul-Aug;71(4):367-375. doi: 10.1016/j.bjane.2021.01.009. Epub 2021 Mar 21.
- Individual participant dataSharing planned: Yes. Data available from the publication date can start. NRS scores will be shared. If requested, data will be shared with anesthesiologists dealing with postoperative pain management.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane block and Quadratus Lumborum Block in people with Post Operative Pain and Appendicitis Acute, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 3 inclusion and 6 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 27 Jul 2022. 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?
Postoperative 24-hours total tramadol hydrochloride consumption (time frame: 24 hours postoperatively). 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 NCT05310266, 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 27 Jul 2022.