Postoperative PainNCT06095908
The Effect of Bilateral Rectus Sheath Block Versus Wound Infiltration in Gynecooncological Patients
An observational study of Postoperative Pain, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain is a serious problem in gynecological oncology patients who underwent median vertical incision. The aim of our study is to compare ultrasound guided bilateral rectus sheath block and local anesthetic wound infiltration application in postoperative pain control. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacain
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 25 Nov 2023
- How long will I take part?
- 4 Months
- 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 65 years
- Women only
- Adult, Older adult
Study population: Between June and October 2023, 60 patients aged ASA II-III, 18-65 years old, who will undergo elective gynecooncological surgery with median incision will participate in the study.
Who may be able to join
- electively gynecooncological surgery patients with median incision
- ASA II-III,
- between 18-65 years
Who cannot join
- ASA IV and above
- over 65 - under 18 years of age
- previous laparotomy
- allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr Lutfi Kırdar City Hospital
Istanbul, Kartal
About this study
Official title: The Effect of Ultrasound-Guided Bilateral Rectus Sheath Block Versus Wound Infiltration on Postoperative Pain in Gynecooncological Patients Undergoing Laparotomy With Midline Incision: Randomized Controlled Triple Blinding Study
Postoperative pain is a serious problem in gynecological oncology patients who underwent median vertical incision. The aim of our study is to compare ultrasound guided bilateral rectus sheath block and local anesthetic wound infiltration application in postoperative pain control.
Read the detailed description
This single-center prospective,observational study was approved by Institutional Ethics Committee (Decision number: 2023/514/257/31, Date: 29/05/2023) and was performed in accordance with the Declaration of Helsinki.. Between June and September 2023, ultrasound guided bilateral rectus sheath block or local anesthesia administered to the patients in the gynecological oncology operating room of the University of Health Sciences Kartal Dr Lutfi Kırdar City Hospital at the end of the surgery. In the postoperative period, the pain level of the patients was recorded with the numerical rating scale at 2, 6, 12 and 24 hours by an anesthesiologist who was unaware of the application. The data were entered into the table by an anesthesiologist who did not know which application was performed. Thus, data were recorded using a randomized triple blinding method in which the patient, the researcher, and the recording staff were blinded.
All patients underwent preoperative evaluation one day before surgery and written informed consent was obtained for participation for the study. The procedure to be performed on the patients was planned in accordance with the randomization made by the statistician. The anesthesiologist who would perform the intervention participated in the study blindly to the drugs and groups. Patients in Group I underwent postoperative ultrasound-guided bilateral rectus sheath block at the T9-10 level with 20 ml of 0.25% bupivacaine (40 ml in total). For the patients in Group II (control group), 20 ml of 0.25% bupivacaine was applied subcutaneously to each wound lip (40 ml in total). At the end of the surgery, 100 mg tramadol iv and paracetamol 1mg/kg iv were administered to both groups as analgesics.
Pain, ranging from 0 (no pain) to 10 (worst imaginable), was queried by another anesthesiologist who was blind to the procedure. 2*1 non-steroidal anti-inflammatory was routinely administered as an analgesic in the ward, but the first application time was planned by questioning the patient's pain. Rescue analgesia with tramadol was administered if the patient ranged the pain >4 . Pain was measured at the 2nd, 6th, 12th and 24th hours postoperatively, and tramadol consumption was recorded.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacain
- Keywords
- postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Bupivacain administered with two different ways to the patients, postoperative pain recorded
| Study group | Role | What they receive |
|---|---|---|
| 'rectus sheath block' | Patients in Group I underwent postoperative USG-guided bilateral rectus sheath block at the T9-10 level with 20 ml of 0.25% bupivacaine (40 ml in total). Receives: Drug: Bupivacain | |
| 'wound infiltration' | Group II (control group), 20 ml of 0.25% bupivacaine was applied subcutaneously to each wound lip (40 ml in total). Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate patients' postoperative pain
The primary aim of this study is to evaluate and compare the postoperative analgesic effectiveness of bilateral rectus sheath block and wound infiltration in gyneco-oncological patients undergoing laparatomy with midline incision. Numeric rating scale (NRS) of 1-10 used for the assessment of postoperative pain.
Measured: postoperative 2,6,12,24 th hours
Secondary outcomes (1)
Evaluate patients' total analgesic consumption
The secondary aim of the study was to evaluate the patients in terms of time to total amount of opioid analgesics (mg ) consumed in 24 hours.
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 posted23 Oct 2023
- Study start15 Jun 2023
- Primary completion25 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merve Bulun Yediyıldız, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095908
- Sponsor's protocol ID
- DrLutfiKirdarANESTESIA
- Status last verified
- May 2024
- First submitted
- 6 Oct 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-Guided Bilateral Rectus Sheath Block Versus Wound Infiltration on Postoperative Pain in Gynecooncological Patients Undergoing Laparotomy With Midline Incision: Randomized Controlled Triple Blinding Study
- ClinicalTrials.gov ID
- NCT06095908
- Acronym / sponsor ID
- DrLutfiKirdarANESTESIA
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 23 Oct 2023 (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.
Postoperative pain is a serious problem in gynecological oncology patients who underwent median vertical incision. The aim of our study is to compare ultrasound guided bilateral rectus sheath block and local anesthetic wound infiltration application in postoperative pain control.
Detailed description
This single-center prospective,observational study was approved by Institutional Ethics Committee (Decision number: 2023/514/257/31, Date: 29/05/2023) and was performed in accordance with the Declaration of Helsinki.. Between June and September 2023, ultrasound guided bilateral rectus sheath block or local anesthesia administered to the patients in the gynecological oncology operating room of the University of Health Sciences Kartal Dr Lutfi Kırdar City Hospital at the end of the surgery. In the postoperative period, the pain level of the patients was recorded with the numerical rating scale at 2, 6, 12 and 24 hours by an anesthesiologist who was unaware of the application. The data were entered into the table by an anesthesiologist who did not know which application was performed. Thus, data were recorded using a randomized triple blinding method in which the patient, the researcher, and the recording staff were blinded.
All patients underwent preoperative evaluation one day before surgery and written informed consent was obtained for participation for the study. The procedure to be performed on the patients was planned in accordance with the randomization made by the statistician. The anesthesiologist who would perform the intervention participated in the study blindly to the drugs and groups. Patients in Group I underwent postoperative ultrasound-guided bilateral rectus sheath block at the T9-10 level with 20 ml of 0.25% bupivacaine (40 ml in total). For the patients in Group II (control group), 20 ml of 0.25% bupivacaine was applied subcutaneously to each wound lip (40 ml in total). At the end of the surgery, 100 mg tramadol iv and paracetamol 1mg/kg iv were administered to both groups as analgesics.
Pain, ranging from 0 (no pain) to 10 (worst imaginable), was queried by another anesthesiologist who was blind to the procedure. 2*1 non-steroidal anti-inflammatory was routinely administered as an analgesic in the ward, but the first application time was planned by questioning the patient's pain. Rescue analgesia with tramadol was administered if the patient ranged the pain >4 . Pain was measured at the 2nd, 6th, 12th and 24th hours postoperatively, and tramadol consumption was recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'rectus sheath block' | – | Drug: BupivacainPatients in Group I underwent postoperative USG-guided bilateral rectus sheath block at the T9-10 level with 20 ml of 0.25% bupivacaine (40 ml in total). |
| 'wound infiltration' | – | Drug: BupivacainGroup II (control group), 20 ml of 0.25% bupivacaine was applied subcutaneously to each wound lip (40 ml in total). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Between June and October 2023, 60 patients aged ASA II-III, 18-65 years old, who will undergo elective gynecooncological surgery with median incision will participate in the study.
Key inclusion criteria (3 listed)
- electively gynecooncological surgery patients with median incision
- ASA II-III,
- between 18-65 years
Key exclusion criteria (4 listed)
- ASA IV and above
- over 65 - under 18 years of age
- previous laparotomy
- allergy to local anesthetics
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 |
|---|---|---|
| BupivacainBupivacain administered with two different ways to the patients, postoperative pain recorded | Drug | 'rectus sheath block', 'wound infiltration' |
Primary outcome
Evaluate patients' postoperative pain
Time frame: postoperative 2,6,12,24 th hours
The primary aim of this study is to evaluate and compare the postoperative analgesic effectiveness of bilateral rectus sheath block and wound infiltration in gyneco-oncological patients undergoing laparatomy with midline incision. Numeric rating scale (NRS) of 1-10 used for the assessment of postoperative pain.
1 secondary outcome
Evaluate patients' total analgesic consumption
Time frame: postoperative 24 hours
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 24 May 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Postoperative Pain, run by Dr. Lutfi Kirdar Kartal Training 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 3 inclusion and 4 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 24 May 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?
Evaluate patients' postoperative pain (time frame: postoperative 2,6,12,24 th hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2024.