Postoperative PainNCT05845385
Postoperative Pain Relief After Major Abdominal Gynecological Surgery
A study testing lumbar epidural analgesia with bupivacaine, transversus abdominis plane block with bupivacaine and wound infiltration with bupivacaine in people with Postoperative Pain, run by Cukurova University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of our study was to compare the effects of Lomber Epidural Analgesia (LEA), Transversus Abdominis Plane (TAP) block and Local Anesthetic Infiltration (LAI) on postoperative morphine consumption, time to first recue analgesic request, pain and patient satisfaction scores and side effects were compared in the… Read more about this study
- Who is it for?
- Ages 18 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- lumbar epidural analgesia with bupivacaine, transversus abdominis plane block with bupivacaine and wound infiltration with bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 May 2024to 1 Sep 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 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-II,
- between the age of 18-69,
- undergoing major gynecological abdominal surgery under general anesthesia
Who cannot join
- lack of patient consent
- ASA > III
- sensitivity or contraindication to study drugs
- conditions in which epidural anesthesia is contraindicated
- emergency and urgent surgery
- inability to comprehend pain scale
- any contraindication to the use of patient controlled analgesia (PCA) device.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cukurova University
Adana, 01130
Cukurova University
Adana
About this study
Official title: Comparison of Lumbar Epidural Analgesia, Transversus Abdominis Plane Block and Wound Infiltration for Postoperative Pain Relief in Major Abdominal Gynecological Surgery
The aim of our study was to compare the effects of Lomber Epidural Analgesia (LEA), Transversus Abdominis Plane (TAP) block and Local Anesthetic Infiltration (LAI) on postoperative morphine consumption, time to first recue analgesic request, pain and patient satisfaction scores and side effects were compared in the patients undergoing major gynecologic/oncology lower abdominal surgery.
Read the detailed description
Following faculty ethical committee approval and written informed consent, 81 patients were included in our prospective, randomized and double-blind study. Patients were divided into 3 groups: lumbar epidural block (Group E), TAP block (Group T), and wound infiltration (Group I). Demographic data, surgical characteristics, hemodynamic values, pain scores at rest and on movement, morphine consumption, additional analgesic requirement, side effects at 1, 2, 6, 12, 24, 36 and 48th hours after surgery, and patient satisfaction scores at 24 and 48th hours were recorded.
- Conditions
- Postoperative Pain
- Being tested
- lumbar epidural analgesia with bupivacaine, transversus abdominis plane block with bupivacaine, wound infiltration with bupivacaine
- Keywords
- epidural analgesia, pain score, morphine, transversus abdominis plane block, wound infiltration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar epidural analgesia with bupivacaineProcedure or surgery
postoperative analgesic method
transversus abdominis plane block with bupivacaineProcedure or surgery
postoperative analgesic method
wound infiltration with bupivacaineProcedure or surgery
postoperative analgesic method
| Study group | Role | What they receive |
|---|---|---|
| lumbar epidural analgesia with bupivacaine | Active comparator | For postoperative analgesia; Lumbar epidural catheter inserted at L3-4 or L4-5 epidural space before anesthesia induction in the sitting position. After the end of surgery but approximately 20 minutes before extubation, 0.125% bupivacaine 20 ml administered through epidural catheter and the catheter was removed. Receives: Procedure: lumbar epidural analgesia with bupivacaine |
| transversus abdominis plane block with bupivacaine | Active comparator | For postoperative analgesia; After the end of surgery but before extubation, USD-guided TAP block was performed with 0.125% bupivacaine 20 ml to the anatomic neurofacial space between the internal oblique and transersus abdominis muscles, bilaterally (10 ml for each side). Receives: Procedure: transversus abdominis plane block with bupivacaine |
| wound infiltration with bupivacaine | Active comparator | For postoperative analgesia; After the end of surgery but before extubation, 0.125% bupivacaine 20 ml administered to the surgical incision site. Receives: Procedure: wound infiltration with bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
At the end of the surgery, the patients were allowed to use the patient controlled analgesia device (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc. St. Paul, MN) was prepared with 40 mg morphine HCl in 100 ml saline. The PCA doses of morphine consisted of a bolus dose of 0.02 mg/kg every 15 minutes without a background infusion. Morphine consumption (mg) was evaluated and recorded postoperative 48 hours.
Measured: change from baseline morphine comsumption at 48 hours
Secondary outcomes (4)
pain scores
postoperative pain scores of the patients were recorded using visual analog scale (VAS; 0=no pain, 10=worst pain)
Measured: change from baseline pain scores at 48 hours
patient satisfaction score
patient satisfaction scores were recorded using patient satisfaction scale (0= worst, 10=excellent)
Measured: postoperative 24 and 48 hours
time to first rescue analgesic
If the patients complained of pain despite the analgesia regimen, iv 50 mg meperidine was given as a rescue analgesic.
Measured: postoperative 48 hours
side effects
all patients were visited after surgery in the ward and side effects were evaluated and recorded
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start6 May 2024
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
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.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakki Unlugenc, Cukurova University
- Investigators
- Hakkı - Unlugenc, Proffessor, Study chair, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845385
- Sponsor's protocol ID
- MAS
- Status last verified
- Sep 2024
- First submitted
- 26 Apr 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lumbar Epidural Analgesia, Transversus Abdominis Plane Block and Wound Infiltration for Postoperative Pain Relief in Major Abdominal Gynecological Surgery
- ClinicalTrials.gov ID
- NCT05845385
- Acronym / sponsor ID
- MAS
- Conditions
- Postoperative Pain
- Keywords
- epidural analgesia, pain score, morphine, transversus abdominis plane block, wound infiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 May 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.
The aim of our study was to compare the effects of Lomber Epidural Analgesia (LEA), Transversus Abdominis Plane (TAP) block and Local Anesthetic Infiltration (LAI) on postoperative morphine consumption, time to first recue analgesic request, pain and patient satisfaction scores and side effects were compared in the patients undergoing major gynecologic/oncology lower abdominal surgery.
Detailed description
Following faculty ethical committee approval and written informed consent, 81 patients were included in our prospective, randomized and double-blind study. Patients were divided into 3 groups: lumbar epidural block (Group E), TAP block (Group T), and wound infiltration (Group I). Demographic data, surgical characteristics, hemodynamic values, pain scores at rest and on movement, morphine consumption, additional analgesic requirement, side effects at 1, 2, 6, 12, 24, 36 and 48th hours after surgery, and patient satisfaction scores at 24 and 48th hours were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lumbar epidural analgesia with bupivacaine | Active comparator | Procedure: lumbar epidural analgesia with bupivacaineFor postoperative analgesia; Lumbar epidural catheter inserted at L3-4 or L4-5 epidural space before anesthesia induction in the sitting position. After the end of surgery but approximately 20 minutes before extubation, 0.125% bupivacaine 20 ml administered through epidural catheter and the catheter was removed. |
| transversus abdominis plane block with bupivacaine | Active comparator | Procedure: transversus abdominis plane block with bupivacaineFor postoperative analgesia; After the end of surgery but before extubation, USD-guided TAP block was performed with 0.125% bupivacaine 20 ml to the anatomic neurofacial space between the internal oblique and transersus abdominis muscles, bilaterally (10 ml for each side). |
| wound infiltration with bupivacaine | Active comparator | Procedure: wound infiltration with bupivacaineFor postoperative analgesia; After the end of surgery but before extubation, 0.125% bupivacaine 20 ml administered to the surgical incision site. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II,
- between the age of 18-69,
- undergoing major gynecological abdominal surgery under general anesthesia
Key exclusion criteria (7 listed)
- lack of patient consent
- ASA > III
- sensitivity or contraindication to study drugs
- conditions in which epidural anesthesia is contraindicated
- emergency and urgent surgery
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 |
|---|---|---|
| lumbar epidural analgesia with bupivacainepostoperative analgesic method | Procedure or surgery | lumbar epidural analgesia with bupivacaine |
| transversus abdominis plane block with bupivacainepostoperative analgesic method | Procedure or surgery | transversus abdominis plane block with bupivacaine |
| wound infiltration with bupivacainepostoperative analgesic method | Procedure or surgery | wound infiltration with bupivacaine |
Primary outcome
morphine consumption
Time frame: change from baseline morphine comsumption at 48 hours
At the end of the surgery, the patients were allowed to use the patient controlled analgesia device (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc. St. Paul, MN) was prepared with 40 mg morphine HCl in 100 ml saline. The PCA doses of morphine consisted of a bolus dose of 0.02 mg/kg every 15 minutes without a background infusion. Morphine consumption (mg) was evaluated and recorded postoperative 48 hours.
4 secondary outcomes
pain scores
Time frame: change from baseline pain scores at 48 hours
patient satisfaction score
Time frame: postoperative 24 and 48 hours
time to first rescue analgesic
Time frame: postoperative 48 hours
side effects
Time frame: postoperative 48 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 19 Sep 2024.
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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.
Hakkı - Unlugenc, Proffessor study chair
Cukurova University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar epidural analgesia with bupivacaine, transversus abdominis plane block with bupivacaine and wound infiltration with bupivacaine in people with Postoperative Pain, run by Cukurova University at 2 sites 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 7 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
morphine consumption (time frame: change from baseline morphine comsumption at 48 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 19 Sep 2024.