UltrasonographyNCT04297046
Ultrasound-guided Two Different Type Blocks for Pain Relief in Totalabdominal Hysterectomy
A study of Ultrasonography, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Effective analgesia after total abdominal hysterectomy is important for faster recovery and preventing complications which depend to pain. A multimodal and preventive approach is preferred to ensure adequate analgesia and to avoid side effects due to high doses of analgesics. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Ultrasonography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 31 Jul 2017
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergone total abdominal hysterectomy with Pfannenstiel incision
- American Society of Anesthesiologist (ASA) I-III
- Patients between the ages of 18-65
Who cannot join
- Patients with bleeding diathesis
- Patients who could not communicate (mental disorder, language problem, etc.)
- Patients with allergies to the drugs used
- Patients who did not wish to participate in the study
- Patients who had an infection in the block area
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Education and Research Hospital
Bursa, 16310
About this study
Official title: Ultrasound-guided Transversus Abdominis Plane Block and Quadratus Lumborum Block as Preventive Analgesia in Total Abdominal Hysterectomy With Pfannenstiel Incision: a Prospective, Randomized Trial
Effective analgesia after total abdominal hysterectomy is important for faster recovery and preventing complications which depend to pain. A multimodal and preventive approach is preferred to ensure adequate analgesia and to avoid side effects due to high doses of analgesics. The hypothesis was that the Quadratus Lumborum block (application of local anesthetics to the side of the abdomen) would be superior to Transversus Abdominis Plane block (application of local anesthetics in front of the abdomen) for analgesia before abdominal incision in total abdominal hysterectomy. The primary goal of the study was to evaluate the feasibility of ultrasound-guided Transversus Abdominis Plane block and Quadratus Lumborum block. The secondary goal was to evaluate postoperative adverse effects and patient satisfaction.
Read the detailed description
The study protocol was approved by the Local Ethics Committee. Written informed consent was obtained from each patient. The study was carried out in accordance with The Code of Ethics of the Declaration of Helsinki. The study was conducted between April 2017 - July 2017 with a prospective, randomized, double-blind design on 62 patients who had undergone total abdominal hysterectomy with Pfannenstiel incision. American Society of Anesthesiologist (ASA) II-III, patients between the ages of 18-75 were included in the study. The participants with bleeding diathesis, those who could not communicate (mental disorder, language problem, etc.), those with allergies to the drugs used, those who did not wish to participate in the study, and those who had an infection in the block area were excluded from the study. The participants were divided into 2 groups with the sealed envelope technique preoperatively Transversus Abdominis Plane Block Procedure Before the surgical procedure, the muscles were screened at the umbilicus plain/mid-axillary line with the ultrasound using a linear probe while the participants in the supine position. The skin, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum were visualized. The block needle was advanced in the posterolateral direction with the in-plain approach. 0.3 ml/kg of 0.25% bupivacaine was administered bilaterally into the space between the internal oblique muscle and the transversus abdominis muscle.
Transmuscular Quadratus Lumborum Block Procedure Quadratus lumborum muscle could be recognized with ultrasound via the convex probe was transversally attached above iliac crest at the midaxillary line while the patients were in the lateral decubitus position. The point of injection with a block needle in transmuscular Quadratus Lumborum Block is between the anterior border of Quadratus lumborum muscle and psoas major muscles. A transmuscular Quadratus Lumborum Block was performed bilaterally with 0,3 ml/kg 0.25% bupivacaine solution injection on each side.
- Conditions
- Ultrasonography
- Being tested
- PCA (patient controlled analgesia)
- Keywords
- Nerve block, analgesia, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCA (patient controlled analgesia)Device
Intravenous Patient-Controlled Analgesia was used for postoperative pain control with a bolus dose of 25 mg Tramadol and a lockout interval of 20 min. The pain was evaluated at different times after the operation, both at rest and movement (Dynamic VAS) at the 0., 2., 6., 12. hours and 24h later. All patients received 1 g iv paracetamol 8 hourly intervals regularly. 75 mg im diclofenac sodium was given as rescue analgesic.
| Study group | Role | What they receive |
|---|---|---|
| QLB for total abdominal hysterectomy | Active comparator | Quadratus lumborum block (QLB) was performed bilaterally with 0,3 ml/kg 0.25% bupivacaine (maximum dose 3 ml/kg) solution injection on each side.Combine patient-controlled intravenous analgesia(same as PCA for TAH arm). Receives: Device: PCA (patient controlled analgesia) |
| TAPB for total abdominal hysterect0my | Active comparator | The transversus abdominis plane block (TAPB)was performed bilaterally with 0.3 ml/kg of 0.25% bupivacaine (maximum dose 3 ml/kg) solution . Combine patient-controlled intravenous analgesia(same as PCA for TAH arm). Receives: Device: PCA (patient controlled analgesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
iv PCA tramadol consumption
tramadol consumption up to 24 hours
Measured: 24 hours
intraoperatively fentanyl use
Total intraoperative fentanyl dose
Measured: during operation
The Visual analogue Scale (VAS)
The Visual Analogue Scale was used to measure the severity of postoperative pain (0= No pain, 10= The worst possible pain) up to 24 hours. Higher scores mean a worse outcome.
Measured: 24 hours
Secondary outcomes (2)
postoperative adverse effects
nausea,vomiting, hypertension and hypotension incidences
Measured: 24 hours
patient and surgeon satisfaction: scores
The patient and surgeon satisfaction score (0= Not satisfied, 4= Very satisfied) were recorded. Higher scores mean a better outcome.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Apr 2017
- Primary completion30 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Canan Yılmaz, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Canan Yilmaz, Principal investigator, Medical Doctor of Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297046
- Sponsor's protocol ID
- 2017-7/9
- Status last verified
- Oct 2020
- First submitted
- 28 Feb 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Transversus Abdominis Plane Block and Quadratus Lumborum Block as Preventive Analgesia in Total Abdominal Hysterectomy With Pfannenstiel Incision: a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT04297046
- Acronym / sponsor ID
- 2017-7/9
- Conditions
- Ultrasonography
- Keywords
- Nerve block, analgesia, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 5 Mar 2020 (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.
Effective analgesia after total abdominal hysterectomy is important for faster recovery and preventing complications which depend to pain. A multimodal and preventive approach is preferred to ensure adequate analgesia and to avoid side effects due to high doses of analgesics. The hypothesis was that the Quadratus Lumborum block (application of local anesthetics to the side of the abdomen) would be superior to Transversus Abdominis Plane block (application of local anesthetics in front of the abdomen) for analgesia before abdominal incision in total abdominal hysterectomy. The primary goal of the study was to evaluate the feasibility of ultrasound-guided Transversus Abdominis Plane block and Quadratus Lumborum block. The secondary goal was to evaluate postoperative adverse effects and patient satisfaction.
Detailed description
The study protocol was approved by the Local Ethics Committee. Written informed consent was obtained from each patient. The study was carried out in accordance with The Code of Ethics of the Declaration of Helsinki. The study was conducted between April 2017 - July 2017 with a prospective, randomized, double-blind design on 62 patients who had undergone total abdominal hysterectomy with Pfannenstiel incision. American Society of Anesthesiologist (ASA) II-III, patients between the ages of 18-75 were included in the study. The participants with bleeding diathesis, those who could not communicate (mental disorder, language problem, etc.), those with allergies to the drugs used, those who did not wish to participate in the study, and those who had an infection in the block area were excluded from the study. The participants were divided into 2 groups with the sealed envelope technique preoperatively Transversus Abdominis Plane Block Procedure Before the surgical procedure, the muscles were screened at the umbilicus plain/mid-axillary line with the ultrasound using a linear probe while the participants in the supine position. The skin, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum were visualized. The block needle was advanced in the posterolateral direction with the in-plain approach. 0.3 ml/kg of 0.25% bupivacaine was administered bilaterally into the space between the internal oblique muscle and the transversus abdominis muscle.
Transmuscular Quadratus Lumborum Block Procedure Quadratus lumborum muscle could be recognized with ultrasound via the convex probe was transversally attached above iliac crest at the midaxillary line while the patients were in the lateral decubitus position. The point of injection with a block needle in transmuscular Quadratus Lumborum Block is between the anterior border of Quadratus lumborum muscle and psoas major muscles. A transmuscular Quadratus Lumborum Block was performed bilaterally with 0,3 ml/kg 0.25% bupivacaine solution injection on each side.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLB for total abdominal hysterectomy | Active comparator | Device: PCA (patient controlled analgesia)Quadratus lumborum block (QLB) was performed bilaterally with 0,3 ml/kg 0.25% bupivacaine (maximum dose 3 ml/kg) solution injection on each side.Combine patient-controlled intravenous analgesia(same as PCA for TAH arm). |
| TAPB for total abdominal hysterect0my | Active comparator | Device: PCA (patient controlled analgesia)The transversus abdominis plane block (TAPB)was performed bilaterally with 0.3 ml/kg of 0.25% bupivacaine (maximum dose 3 ml/kg) solution . Combine patient-controlled intravenous analgesia(same as PCA for TAH arm). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergone total abdominal hysterectomy with Pfannenstiel incision
- American Society of Anesthesiologist (ASA) I-III
- Patients between the ages of 18-65
Key exclusion criteria (5 listed)
- Patients with bleeding diathesis
- Patients who could not communicate (mental disorder, language problem, etc.)
- Patients with allergies to the drugs used
- Patients who did not wish to participate in the study
- Patients who had an infection in the block area
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 |
|---|---|---|
| PCA (patient controlled analgesia)Intravenous Patient-Controlled Analgesia was used for postoperative pain control with a bolus dose of 25 mg Tramadol and a lockout interval of 20 min. The pain was evaluated at different times after the operation, both at rest and movement (Dynamic VAS) at the 0., 2., 6., 12. hours and 24h later. All patients received 1 g iv paracetamol 8 hourly intervals regularly. 75 mg im diclofenac sodium was given as rescue analgesic. | Device | QLB for total abdominal hysterectomy, TAPB for total abdominal hysterect0my |
Primary outcome
iv PCA tramadol consumption
Time frame: 24 hours
tramadol consumption up to 24 hours
intraoperatively fentanyl use
Time frame: during operation
Total intraoperative fentanyl dose
The Visual analogue Scale (VAS)
Time frame: 24 hours
The Visual Analogue Scale was used to measure the severity of postoperative pain (0= No pain, 10= The worst possible pain) up to 24 hours. Higher scores mean a worse outcome.
2 secondary outcomes
postoperative adverse effects
Time frame: 24 hours
patient and surgeon satisfaction: scores
Time frame: 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 27 Oct 2020.
- 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. This study is not recruiting at the moment.
Canan Yilmaz principal investigator
Medical Doctor of Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Ultrasonography, run by Bursa Yuksek Ihtisas 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 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 27 Oct 2020. 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?
iv PCA tramadol consumption (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 27 Oct 2020.