Postoperative PainNCT06342076
Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery
A study testing Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block and Patients undergoing rectus sheat block and posterior transversus abdominis plane block in people with Postoperative Pain and Postoperative Complications, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Complications, Analgesia
- What is being tested?
- Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block and Patients undergoing rectus sheat block and posterior transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Mar 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years
- ASA II-III
Who cannot join
- Those who are allergic to local anesthetics
- BMI> 40 kg/m2
- Those with chronic pain
- Those with a history of previous abdominal surgery
- Patients who refuse the use of postoperative patient-controlled analgesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, Basaksehir
About this study
Official title: Comparison of the Efficacy of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block for Postoperative Analgesia in Major Open Gynaecological Cancer Surgery: a Prospective Randomised Study
The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.
The main question(s) it aims to answer are:
[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? ] [Is there a difference in pain scores at 24 hours after surgery? ] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods.
Read the detailed description
This prospective, randomized study was conducted at Başakşehir Çam and Sakura City Hospital in accordance with the Declaration of Helsinki. After ethics committee approval (decision no: 2023-596, date: 22.11.2023) and written consent from all patients, the study was conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. In the study, which included a total of 50 patients, the patients were divided into two groups: subcostal transversus abdominis plane block (STAPB) or rectus sheath block (RSB). Postoperative 24-hour VAS values, opioid demand and administration amounts in intravenous patient-controlled analgesia, presence of nausea and vomiting, surgical complications and length of hospital stay were evaluated (6th hour, 12th hour, 24th hour).
- Being tested
- Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block, Patients undergoing rectus sheat block and posterior transversus abdominis plane block
- Medical subject headings
- Pain, Postoperative, Postoperative Complications, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane blockProcedure or surgery
To prevent postoperative pain, the researchers applied a subcostal transversus abdominis plane block in addition to the posterior transversus abdominis plane block to a group of patients who underwent surgery with a midline incision due to major gynecological cancer.
Patients undergoing rectus sheat block and posterior transversus abdominis plane blockProcedure or surgery
To prevent postoperative pain, the researchers applied a rectus sheath block in addition to the posterior transversus abdominis plane block to a group of patients who were operated on through a midline incision due to major gynecological cancer.
| Study group | Role | What they receive |
|---|---|---|
| Group1: Subcostal transversus abdominis plane block(STAPB) | Experimental | Subcostal transversus abdominis plane block(STAPB) Receives: Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block; Procedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane block |
| Group 2: Rectus sheat block(RSB) | Experimental | Rectus sheat block(RSB) Receives: Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block; Procedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
visuel analog scale
Our primer aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Numeric Rating Scale(NRS) was used to assess postoperative pain.6th, 12th, 24th hour NRS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: 24 hours postoperatively
Secondary outcomes (1)
amount of opioid used
Our secondary aim was to evaluate the opioid amount (mg) in the first 24 hours of intravenously administered opioids with patient-controlled analgesia.
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 posted2 Apr 2024
- Study start1 Jan 2024
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Model description
- Prospective randomize study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342076
- Sponsor's protocol ID
- 2023-596
- Status last verified
- Jun 2024
- First submitted
- 21 Mar 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bhatia N, Arora S, Jyotsna W, Kaur G. Comparison of posterior and subcostal approaches to ultrasound-guided transverse abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy. J Clin Anesth. 2014 Jun;26(4):294-9. doi: 10.1016/j.jclinane.2013.11.023. Epub 2014 Jun 2.
PubMed 24882606Hebbard 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.
PubMed 20830871Yorukoglu HU, Sahin T, Oge Kula A. Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Caesarean Delivery: A Randomised Controlled Trial. Turk J Anaesthesiol Reanim. 2023 Feb;51(1):43-48. doi: 10.5152/TJAR.2023.22724.
PubMed 36847318Soliz JM, Lipski I, Hancher-Hodges S, Speer BB, Popat K. Subcostal Transverse Abdominis Plane Block for Acute Pain Management: A Review. Anesth Pain Med. 2017 Oct 20;7(5):e12923. doi: 10.5812/aapm.12923. eCollection 2017 Oct.
PubMed 29696110Abdelsalam K, Mohamdin OW. Ultrasound-guided rectus sheath and transversus abdominis plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled study. Saudi J Anaesth. 2016 Jan-Mar;10(1):25-8. doi: 10.4103/1658-354X.169470.
PubMed 26955306
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block for Postoperative Analgesia in Major Open Gynaecological Cancer Surgery: a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT06342076
- Acronym / sponsor ID
- 2023-596
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 2 Apr 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.
The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.
The main question(s) it aims to answer are:
[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? ] [Is there a difference in pain scores at 24 hours after surgery? ] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods.
Detailed description
This prospective, randomized study was conducted at Başakşehir Çam and Sakura City Hospital in accordance with the Declaration of Helsinki. After ethics committee approval (decision no: 2023-596, date: 22.11.2023) and written consent from all patients, the study was conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. In the study, which included a total of 50 patients, the patients were divided into two groups: subcostal transversus abdominis plane block (STAPB) or rectus sheath block (RSB). Postoperative 24-hour VAS values, opioid demand and administration amounts in intravenous patient-controlled analgesia, presence of nausea and vomiting, surgical complications and length of hospital stay were evaluated (6th hour, 12th hour, 24th hour).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomize study
| Arm | Type | Receives |
|---|---|---|
| Group1: Subcostal transversus abdominis plane block(STAPB) | Experimental | Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block, Procedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane blockSubcostal transversus abdominis plane block(STAPB) |
| Group 2: Rectus sheat block(RSB) | Experimental | Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block, Procedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane blockRectus sheat block(RSB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years
- ASA II-III
Key exclusion criteria (5 listed)
- Those who are allergic to local anesthetics
- BMI> 40 kg/m2
- Those with chronic pain
- Those with a history of previous abdominal surgery
- Patients who refuse the use of postoperative patient-controlled analgesia
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 |
|---|---|---|
| Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane blockTo prevent postoperative pain, the researchers applied a subcostal transversus abdominis plane block in addition to the posterior transversus abdominis plane block to a group of patients who underwent surgery with a midline incision due to major gynecological cancer. | Procedure or surgery | Group 2: Rectus sheat block(RSB), Group1: Subcostal transversus abdominis plane block(STAPB) |
| Patients undergoing rectus sheat block and posterior transversus abdominis plane blockTo prevent postoperative pain, the researchers applied a rectus sheath block in addition to the posterior transversus abdominis plane block to a group of patients who were operated on through a midline incision due to major gynecological cancer. | Procedure or surgery | Group 2: Rectus sheat block(RSB), Group1: Subcostal transversus abdominis plane block(STAPB) |
Primary outcome
visuel analog scale
Time frame: 24 hours postoperatively
Our primer aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Numeric Rating Scale(NRS) was used to assess postoperative pain.6th, 12th, 24th hour NRS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
1 secondary outcome
amount of opioid used
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 11 Jun 2024.
- Results publication: PubMed 24882606Bhatia N, Arora S, Jyotsna W, Kaur G. Comparison of posterior and subcostal approaches to ultrasound-guided transverse abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy. J Clin Anesth. 2014 Jun;26(4):294-9. doi: 10.1016/j.jclinane.2013.11.023. Epub 2014 Jun 2.
- Results publication: PubMed 20830871Hebbard 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.
- Results publication: PubMed 36847318Yorukoglu HU, Sahin T, Oge Kula A. Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Caesarean Delivery: A Randomised Controlled Trial. Turk J Anaesthesiol Reanim. 2023 Feb;51(1):43-48. doi: 10.5152/TJAR.2023.22724.
- Results publication: PubMed 29696110Soliz JM, Lipski I, Hancher-Hodges S, Speer BB, Popat K. Subcostal Transverse Abdominis Plane Block for Acute Pain Management: A Review. Anesth Pain Med. 2017 Oct 20;7(5):e12923. doi: 10.5812/aapm.12923. eCollection 2017 Oct.
- Results publication: PubMed 26955306Abdelsalam K, Mohamdin OW. Ultrasound-guided rectus sheath and transversus abdominis plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled study. Saudi J Anaesth. 2016 Jan-Mar;10(1):25-8. doi: 10.4103/1658-354X.169470.
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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.
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 Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block and Patients undergoing rectus sheat block and posterior transversus abdominis plane block in people with Postoperative Pain and Postoperative Complications, 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 2 inclusion and 5 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 11 Jun 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?
visuel analog scale (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 NCT06342076, which also lists 5 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 11 Jun 2024.