Gynecological Cancer SurgeryNCT06382376
The Effect of Analgesia Methods Applied in Gynecological Cancer Surgeries on Postoperative Analgesia
An observational study of Gynecological Cancer Surgery and Regional Anesthesia Morbidity, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Cancer Surgery, Regional Anesthesia Morbidity
- What is being tested?
- Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Mar 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Between June 1, 2023 and December 1, 2023, 71 patients over the age of 18 who underwent surgery for ASA II and III gynecological cancer, to whom we applied intrathecal morphine or four-quadrant transversus abdominis plane block (TAPB) from peripheral nerve blocks for postoperative analgesia, were included in the study.
Who may be able to join
- 18 years
- Patients who have undergone gynecological cancer surgery
Who cannot join
- <18 years
- Those with missing data
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: Four-quadrant Transversus Abdominis Plane Block Versus Intrathecal Morphine in Gynecological Cancer Surgeries: a Single-center Retrospective Study.
The aim of this study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries.
The key question(s) it aims to answer are:
[Is intrathecal morphine more effective in postoperative analgesia?] Patients who underwent gynecological cancer surgery were examined retrospectively. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia on pain scores and postoperative opioid use.
Read the detailed description
Our study was designed retrospectively. The investigators evaluated analgesia methods in patients who underwent laparoscopic or open surgery due to gynecological cancer between June 2023 and December 2023. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block on postoperative analgesia and opioid use.
Group 1: Intrathecal morphine administered group Group 2: Four quadrant transversus abdominis plane block applied group
- Being tested
- Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group
- Keywords
- gynecological cancer surgery, periferal block, neuraxial block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied groupProcedure or surgery
Also called Group 1: Intrathecal morphine administered group, Group 2: Four quadrant transversus abdominis plane block applied group
Intrathecal morphine administered group and Four quadrant transversus abdominis plane block applied group
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Intrathecal morphine administered group | Group 1: Intrathecal morphine administered group Receives: Procedure: Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group | |
| Group 2: Four quadrant transversus abdominis plane block applied group | Group 2: Four quadrant transversus abdominis plane block applied group Receives: Procedure: Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative numerical rating scale
Our primary aim was to evaluate numerical rating scale at 24 hours postoperatively. numerical rating scale(NRS) was used to assess postoperative pain. 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)
postoperative opioid use
Our secondary aim was to evaluate opioid demand and consumption amounts in the postoperative 24 hours.
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 posted24 Apr 2024
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Mar 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 Gynecological Cancer SurgeryStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
- Target duration
- 1 Month
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
- Investigators
- Duygu Akyol, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382376
- Sponsor's protocol ID
- 2024-60
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Black KA, Nelson G, Goucher N, Foley J, Pin S, Chong M, Ghosh S, Bisch SP. Effect of transversus abdominis plane block on postoperative outcomes in gynecologic oncology patients managed on an Enhanced Recovery After Surgery pathway. Gynecol Oncol. 2023 Nov;178:1-7. doi: 10.1016/j.ygyno.2023.09.003. Epub 2023 Sep 18.
PubMed 37729808Niraj G, Kelkar A, Hart E, Kaushik V, Fleet D, Jameson J. Four quadrant transversus abdominis plane block and continuous transversus abdominis plane analgesia: a 3-year prospective audit in 124 patients. J Clin Anesth. 2015 Nov;27(7):579-84. doi: 10.1016/j.jclinane.2015.07.005. Epub 2015 Aug 28.
PubMed 26319886Pirie K, Traer E, Finniss D, Myles PS, Riedel B. Current approaches to acute postoperative pain management after major abdominal surgery: a narrative review and future directions. Br J Anaesth. 2022 Sep;129(3):378-393. doi: 10.1016/j.bja.2022.05.029. Epub 2022 Jul 6.
PubMed 35803751Meylan N, Elia N, Lysakowski C, Tramer MR. Benefit and risk of intrathecal morphine without local anaesthetic in patients undergoing major surgery: meta-analysis of randomized trials. Br J Anaesth. 2009 Feb;102(2):156-67. doi: 10.1093/bja/aen368.
PubMed 19151046
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four-quadrant Transversus Abdominis Plane Block Versus Intrathecal Morphine in Gynecological Cancer Surgeries: a Single-center Retrospective Study.
- ClinicalTrials.gov ID
- NCT06382376
- Acronym / sponsor ID
- 2024-60
- Keywords
- gynecological cancer surgery, periferal block, neuraxial block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 24 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 study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries.
The key question(s) it aims to answer are:
[Is intrathecal morphine more effective in postoperative analgesia?] Patients who underwent gynecological cancer surgery were examined retrospectively. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia on pain scores and postoperative opioid use.
Detailed description
Our study was designed retrospectively. The investigators evaluated analgesia methods in patients who underwent laparoscopic or open surgery due to gynecological cancer between June 2023 and December 2023. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block on postoperative analgesia and opioid use.
Group 1: Intrathecal morphine administered group Group 2: Four quadrant transversus abdominis plane block applied group
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Intrathecal morphine administered group | – | Procedure: Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied groupGroup 1: Intrathecal morphine administered group |
| Group 2: Four quadrant transversus abdominis plane block applied group | – | Procedure: Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied groupGroup 2: Four quadrant transversus abdominis plane block applied group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Between June 1, 2023 and December 1, 2023, 71 patients over the age of 18 who underwent surgery for ASA II and III gynecological cancer, to whom we applied intrathecal morphine or four-quadrant transversus abdominis plane block (TAPB) from peripheral nerve blocks for postoperative analgesia, were included in the study.
Key inclusion criteria (2 listed)
- 18 years
Key exclusion criteria (2 listed)
- <18 years
- Those with missing data
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 |
|---|---|---|
| Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied groupAlso: Group 1: Intrathecal morphine administered group, Group 2: Four quadrant transversus abdominis plane block applied groupIntrathecal morphine administered group and Four quadrant transversus abdominis plane block applied group | Procedure or surgery | Group 1: Intrathecal morphine administered group, Group 2: Four quadrant transversus abdominis plane block applied group |
Primary outcome
postoperative numerical rating scale
Time frame: 24 hours postoperatively
Our primary aim was to evaluate numerical rating scale at 24 hours postoperatively. numerical rating scale(NRS) was used to assess postoperative pain. NRS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
1 secondary outcome
postoperative opioid use
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 26 Apr 2024.
- Results publication: PubMed 37729808Black KA, Nelson G, Goucher N, Foley J, Pin S, Chong M, Ghosh S, Bisch SP. Effect of transversus abdominis plane block on postoperative outcomes in gynecologic oncology patients managed on an Enhanced Recovery After Surgery pathway. Gynecol Oncol. 2023 Nov;178:1-7. doi: 10.1016/j.ygyno.2023.09.003. Epub 2023 Sep 18.
- Results publication: PubMed 26319886Niraj G, Kelkar A, Hart E, Kaushik V, Fleet D, Jameson J. Four quadrant transversus abdominis plane block and continuous transversus abdominis plane analgesia: a 3-year prospective audit in 124 patients. J Clin Anesth. 2015 Nov;27(7):579-84. doi: 10.1016/j.jclinane.2015.07.005. Epub 2015 Aug 28.
- Results publication: PubMed 35803751Pirie K, Traer E, Finniss D, Myles PS, Riedel B. Current approaches to acute postoperative pain management after major abdominal surgery: a narrative review and future directions. Br J Anaesth. 2022 Sep;129(3):378-393. doi: 10.1016/j.bja.2022.05.029. Epub 2022 Jul 6.
- Results publication: PubMed 19151046Meylan N, Elia N, Lysakowski C, Tramer MR. Benefit and risk of intrathecal morphine without local anaesthetic in patients undergoing major surgery: meta-analysis of randomized trials. Br J Anaesth. 2009 Feb;102(2):156-67. doi: 10.1093/bja/aen368.
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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.
Duygu Akyol principal investigator
Başakşehir Çam & Sakura City Hospital
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 Gynecological Cancer Surgery and Regional Anesthesia Morbidity, 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 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 26 Apr 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?
postoperative numerical rating 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 NCT06382376, 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 26 Apr 2024.