Postoperative PainNCT06681571
Comparison of Analgesic Effects of TAP Block and RSB in RALPs
An observational study of Postoperative Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this research, we aim to compare the postoperative analgesic efficacy of these two peripheral blocks in patients undergoing RALP who have received preoperative TAP block and RSB block. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- TAP Block and RSB
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 30 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-79 who underwent robotic radical prostatectomy and have ASA (American Society of Anesthesiologists) physical status score of 1-3.
Who may be able to join
- Patients aged 18-79 who underwent robotic radical prostatectomy
- Patients have ASA (American Society of Anesthesiologists) physical status score of 1-3.
Who cannot join
- Patients with an allergy to local anesthetic agents
- a platelet count below 100,000
- INR value above 2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Analgesic Effects of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block in Robotic-Assisted Laparoscopic Prostatectomies
In this research, we aim to compare the postoperative analgesic efficacy of these two peripheral blocks in patients undergoing RALP who have received preoperative TAP block and RSB block.
Read the detailed description
"Robotic-assisted laparoscopic prostatectomy (RALP) is a minimally invasive and superior technique that provides better visualization and maneuverability compared to open and laparoscopic surgical techniques. Previous studies have shown that RALP offers better postoperative oncological and physiological outcomes compared to open and laparoscopic techniques. However, RALP patients still experience pain lasting for several days postoperatively, which requires the use of analgesics such as opioids. This pain is associated with port site incisions, dissection of the prostate and surrounding tissues, bladder spasms, and transurethral catheter irritation. For this purpose, previous studies have utilized central and peripheral methods to reduce postoperative pain. Previous studies have demonstrated the analgesic benefits of TAP block and rectus sheath block in robotic-assisted radical prostatectomies. However, the number of studies in this area is limited. In this research, we aim to compare the postoperative analgesic efficacy of these two peripheral blocks in patients undergoing RALP who have received preoperative TAP block and RSB block.
- Conditions
- Postoperative Pain
- Being tested
- TAP Block, RSB
- Keywords
- transversus abdominis plane block, Rectus sheath block, Robot-assisted laparoscopic prostatectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP BlockOther
TAP block will be performed immediately after the induction of anesthesia, under ultrasond guidence.
RSBOther
Rectus Sheath block will be performed immediately after the induction of anesthesia, under Ultrasond guidence.
| Study group | Role | What they receive |
|---|---|---|
| TAP Group | TAP block will be performed immediately after the induction of anesthesia, under ultrasond guidence. Receives: Other: TAP Block | |
| RSB Group | RSB block will be performed immediately after the induction of anesthesia, under ultrasond guidence. Receives: Other: RSB |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operatif analgesia consumption
postoperative iv-PCA tramadole dose for the first 24 hours from iv-PCA devices.
Measured: postoperative 24 hous
Secondary outcomes (9)
numerical rating scale (NRS) at rest
Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient
Measured: popstoperative 1. hour
numerical rating scale (NRS) at rest
Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient
Measured: postoperative 6. hour
numerical rating scale (NRS) at rest
Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient
Measured: postoperative 16. hour
numerical rating scale (NRS) at rest
Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient
Measured: postoperative 24. hour
NRS during coughing
The NRS for pain during coughing will be recorded by asking the patient
Measured: postoperative1. hour
NRS during coughing
The NRS for pain during coughing will be recorded by asking the patient
Measured: postoperative 6. hour
NRS during coughing
The NRS for pain during coughing will be recorded by asking the patient
Measured: postoperative 16. hour
NRS during coughing
The NRS for pain during coughing will be recorded by asking the patient
Measured: postoperative24. hour
postoperative nosia and vomiting (PONV)
Recording the presence or absence of nausea and vomiting in the patient within the first 24 hours postoperatively
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion20 Jan 2025 (estimated)
- Study completion30 Jan 2025 (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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeynep Koc, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681571
- Sponsor's protocol ID
- ZeynepKoc002
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taninishi H, Matsusaki T, Morimatsu H. Transversus Abdominis Plane Block Reduced Early Postoperative Pain after Robot-assisted Prostatectomy: a Randomized Controlled Trial. Sci Rep. 2020 Feb 28;10(1):3761. doi: 10.1038/s41598-020-60687-y.
PubMed 32111916Beilstein CM, Huber M, Furrer MA, Loffel LM, Wuethrich PY, Engel D. Impact of analgesic techniques on early quality of recovery after prostatectomy: A 3-arm, randomized trial. Eur J Pain. 2022 Oct;26(9):1990-2002. doi: 10.1002/ejp.2020. Epub 2022 Aug 21.
PubMed 35960649Cosarcan SK, Gurkan Y, Manici M, Ozdemir I, Kilic M, Esen T, Ercelen O. The effect of ultrasound-guided rectus sheath block on postoperative analgesia in robot assisted prostatectomy: A randomized controlled trial. Medicine (Baltimore). 2024 Apr 26;103(17):e37975. doi: 10.1097/MD.0000000000037975.
PubMed 38669407
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effects of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block in Robotic-Assisted Laparoscopic Prostatectomies
- ClinicalTrials.gov ID
- NCT06681571
- Acronym / sponsor ID
- ZeynepKoc002
- Conditions
- Postoperative Pain
- Keywords
- transversus abdominis plane block, Rectus sheath block, Robot-assisted laparoscopic prostatectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 8 Nov 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.
In this research, we aim to compare the postoperative analgesic efficacy of these two peripheral blocks in patients undergoing RALP who have received preoperative TAP block and RSB block.
Detailed description
"Robotic-assisted laparoscopic prostatectomy (RALP) is a minimally invasive and superior technique that provides better visualization and maneuverability compared to open and laparoscopic surgical techniques. Previous studies have shown that RALP offers better postoperative oncological and physiological outcomes compared to open and laparoscopic techniques. However, RALP patients still experience pain lasting for several days postoperatively, which requires the use of analgesics such as opioids. This pain is associated with port site incisions, dissection of the prostate and surrounding tissues, bladder spasms, and transurethral catheter irritation. For this purpose, previous studies have utilized central and peripheral methods to reduce postoperative pain. Previous studies have demonstrated the analgesic benefits of TAP block and rectus sheath block in robotic-assisted radical prostatectomies. However, the number of studies in this area is limited. In this research, we aim to compare the postoperative analgesic efficacy of these two peripheral blocks in patients undergoing RALP who have received preoperative TAP block and RSB block.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Group | – | Other: TAP BlockTAP block will be performed immediately after the induction of anesthesia, under ultrasond guidence. |
| RSB Group | – | Other: RSBRSB block will be performed immediately after the induction of anesthesia, under ultrasond guidence. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-79 who underwent robotic radical prostatectomy and have ASA (American Society of Anesthesiologists) physical status score of 1-3.
Key inclusion criteria (2 listed)
- Patients aged 18-79 who underwent robotic radical prostatectomy
- Patients have ASA (American Society of Anesthesiologists) physical status score of 1-3.
Key exclusion criteria (3 listed)
- Patients with an allergy to local anesthetic agents
- a platelet count below 100,000
- INR value above 2
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 |
|---|---|---|
| TAP BlockTAP block will be performed immediately after the induction of anesthesia, under ultrasond guidence. | Other | TAP Group |
| RSBRectus Sheath block will be performed immediately after the induction of anesthesia, under Ultrasond guidence. | Other | RSB Group |
Primary outcome
post operatif analgesia consumption
Time frame: postoperative 24 hous
postoperative iv-PCA tramadole dose for the first 24 hours from iv-PCA devices.
9 secondary outcomes
numerical rating scale (NRS) at rest
Time frame: popstoperative 1. hour
numerical rating scale (NRS) at rest
Time frame: postoperative 6. hour
numerical rating scale (NRS) at rest
Time frame: postoperative 16. hour
numerical rating scale (NRS) at rest
Time frame: postoperative 24. hour
NRS during coughing
Time frame: postoperative1. hour
NRS during coughing
Time frame: postoperative 6. hour
NRS during coughing
Time frame: postoperative 16. hour
NRS during coughing
Time frame: postoperative24. hour
postoperative nosia and vomiting (PONV)
Time frame: postoperative 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 32111916Taninishi H, Matsusaki T, Morimatsu H. Transversus Abdominis Plane Block Reduced Early Postoperative Pain after Robot-assisted Prostatectomy: a Randomized Controlled Trial. Sci Rep. 2020 Feb 28;10(1):3761. doi: 10.1038/s41598-020-60687-y.
- Background: PubMed 35960649Beilstein CM, Huber M, Furrer MA, Loffel LM, Wuethrich PY, Engel D. Impact of analgesic techniques on early quality of recovery after prostatectomy: A 3-arm, randomized trial. Eur J Pain. 2022 Oct;26(9):1990-2002. doi: 10.1002/ejp.2020. Epub 2022 Aug 21.
- Background: PubMed 38669407Cosarcan SK, Gurkan Y, Manici M, Ozdemir I, Kilic M, Esen T, Ercelen O. The effect of ultrasound-guided rectus sheath block on postoperative analgesia in robot assisted prostatectomy: A randomized controlled trial. Medicine (Baltimore). 2024 Apr 26;103(17):e37975. doi: 10.1097/MD.0000000000037975.
- 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.
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 Diskapi Yildirim Beyazit Education and Research 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 3 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: opening soon, as of the sponsor's last update on 8 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Koc (+905345958843, zeynepyilmazkoc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operatif analgesia consumption (time frame: postoperative 24 hous). 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 NCT06681571, 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 8 Nov 2024.