Post Operative PainNCT05780333
Effect of Different Plane Blocks on Quality of Recovery and Postoperative Pain After Laparoscopic Hysterectomy
A study testing TAP block and ESP block in people with Post Operative Pain, run by Mentese State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate in effect of tap block and esp block on quality of recovery and postoperative pain after laparoscopic hysterectomy. The main question it aims to answer are: Are these two plane blocks used superior to each other? Participants; will fill out the preoperative questionnaire… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- TAP block and ESP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2023to 1 Jul 2023
- 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
- Female patients who will undergo hysterectomy under elective conditions
- 18- 65 years
- ASA I-II patients
Who cannot join
- Refusal during registration, request to be excluded from the study, failure to give informed consent
- Under 18 years old and upper 65 years old
- ASA III-IV patients
- Chronic opioid use
- Presence of infection at the injection site
- Renal failure / Liver failure
Show all 9Show fewer
- Bupivacaine sensitivity
- Use of anticoagulants
- BMI < 18,5 , BMI >35
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pelin Dilsiz Eker
Muğla, Menteşe, 48050
pelin dilsiz eker, MD, 05378401872, pelin.dlsz@hotmail.com
About this study
Official title: Effect of Erector Spinae Plane Block and Transversus Abdominis Plane Block on Quality of Recovery and Postoperative Pain After Laparoscopic Hysterectomy; Randomized, Double-blinded Clinical Trial
The goal of this clinical trial is to evaluate in effect of tap block and esp block on quality of recovery and postoperative pain after laparoscopic hysterectomy. The main question it aims to answer are: Are these two plane blocks used superior to each other? Participants;
- will fill out the preoperative questionnaire
- will fill out the postoperative questionnaire
- will report their pain status according to the NRS score
Read the detailed description
Standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). Generally, opiates and NSAIDs are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. The concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. It consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. Local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management.
Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the spinal nerves. And this block provides visceral and somatic pain block.
Transversus Abdominis plane (TAP) block involves the injection of LA between the transversus abdominis (TA) and internal oblique (IO) muscles.This interfascial plane contains the intercostal, subcostal, iliohypogastric, and ilioinguinal nerves. These nerves give sensation to the anterior and lateral abdominal wall as well as the parietal peritoneum, providing only somatic and not visceral analgesia.
- Conditions
- Post Operative Pain
- Being tested
- TAP block, ESP block
- Keywords
- tap block, esp block, postoperative pain, recovery
- 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 blockProcedure or surgery
Bilateral tap block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each
ESP blockProcedure or surgery
Bilateral esp block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each
| Study group | Role | What they receive |
|---|---|---|
| tap block | Other | Tap block is one of the frequently used field blocks for analgesia management of abdominal surgery.
At the end of surgery and general anesthesia, transversus abdominis fascial plane will be detected with using lineer usg probe. With in-plane tecnique after placement of the needle in the transversus abdominis fascial plane, and careful aspiration to exclude vascular puncture, a test dose of 1 mL will be injected to determine resistance to flow, and confirm needle tip placement within the fascial plane. After this, 20 ml local anaestetic mixture will be injected through the needle. The TAP block will be then performed on the opposite side using an identical technique. Receives: Procedure: TAP block |
| esp block | Active comparator | The effectiveness of esp block is also evaluated in abdominal surgery after spinal surgery, thoracic and cardiovascular surgery.
At the end of surgery and general anesthesia, in the lateral decubitus position, the linear probe will be placed approximately 3 cm lateral to the T10 spinous process, in the parasagittal plane. With the in-plane technique, when the block needle rests on the transverse process (approximately 3cm in depth), the erector spina plan will be confirmed with a 0.5-1 mL 0.9% NaCl test dose. 20 ml of local anesthetic mixture will be applied to the confirmed area. The procedure will be applied bilaterally. Receives: Procedure: ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery 40 Questionnaire
The global Quality of Recovery-40 aggregate score is a scale from (1 to 5, where: 1 = very poor and 5 = excellent)
Measured: 24 hours after surgery.
Secondary outcomes (1)
Postoperative pain
is a numerical rating scale from (1 to 10, where: 1 is the mildest and 10 the worst possible)
Measured: 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start27 Jan 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion1 Jul 2023 (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 Post Operative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blind, randomized control clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mentese State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pelin Dilsiz Eker, Mentese State Hospital
- Investigators
- pelin dilsiz eker, MD, Principal investigator, Mentese State HospitalIsmail Gökbel, MD, Study chair, Mentese State HospitalSinem Sari Ozturk, MD, Study director, Aydin Adnan Menderes University, Department of anesthesiology and reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780333
- Sponsor's protocol ID
- 2022/12
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yap JY, Bhat M, McMullen W, Ragupathy K. Novel use of laparoscopic-guided TAP block in total laparoscopic hysterectomy. J Obstet Gynaecol. 2018 Jul;38(5):736. doi: 10.1080/01443615.2018.1444402.
PubMed 29944049Rosato C, Santonastaso DP, de Chiara A, Viola L, Russo E, Piccioni FG, Agnoletti V. Erector spinae plane block for pain management in laparoscopic hysterectomy and bilateral oophorectomy. J Clin Anesth. 2021 Jun;70:110184. doi: 10.1016/j.jclinane.2021.110184. Epub 2021 Feb 6. No abstract available.
PubMed 33561705Yagi K, Adachi K, Tanaka E, Toda A, Miyoshi Y, Funada R, Yamamoto Y. The Role of Preoperative and Postoperative Transversus Abdominis Plane and Rectus Sheath Block in Patients Undergoing Total Laparoscopic Hysterectomy. J Perianesth Nurs. 2020 Oct;35(5):491-495. doi: 10.1016/j.jopan.2020.02.014. Epub 2020 Jun 18.
PubMed 32565029
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Erector Spinae Plane Block and Transversus Abdominis Plane Block on Quality of Recovery and Postoperative Pain After Laparoscopic Hysterectomy; Randomized, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05780333
- Acronym / sponsor ID
- 2022/12
- Conditions
- Post Operative Pain
- Keywords
- tap block, esp block, postoperative pain, recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mentese State HospitalOther government
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 22 Mar 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 goal of this clinical trial is to evaluate in effect of tap block and esp block on quality of recovery and postoperative pain after laparoscopic hysterectomy. The main question it aims to answer are: Are these two plane blocks used superior to each other? Participants;
- will fill out the preoperative questionnaire
- will fill out the postoperative questionnaire
- will report their pain status according to the NRS score
Detailed description
Standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). Generally, opiates and NSAIDs are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. The concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. It consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. Local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management.
Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the spinal nerves. And this block provides visceral and somatic pain block.
Transversus Abdominis plane (TAP) block involves the injection of LA between the transversus abdominis (TA) and internal oblique (IO) muscles.This interfascial plane contains the intercostal, subcostal, iliohypogastric, and ilioinguinal nerves. These nerves give sensation to the anterior and lateral abdominal wall as well as the parietal peritoneum, providing only somatic and not visceral analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double blind, randomized control clinical trial.
| Arm | Type | Receives |
|---|---|---|
| tap block | Other | Procedure: TAP blockTap block is one of the frequently used field blocks for analgesia management of abdominal surgery. At the end of surgery and general anesthesia, transversus abdominis fascial plane will be detected with using lineer usg probe. With in-plane tecnique after placement of the needle in the transversus abdominis fascial plane, and careful aspiration to exclude vascular puncture, a test dose of 1 mL will be injected to determine resistance to flow, and confirm needle tip placement within the fascial plane. After this, 20 ml local anaestetic mixture will be injected through the needle. The TAP block will be then performed on the opposite side using an identical technique. |
| esp block | Active comparator | Procedure: ESP blockThe effectiveness of esp block is also evaluated in abdominal surgery after spinal surgery, thoracic and cardiovascular surgery. At the end of surgery and general anesthesia, in the lateral decubitus position, the linear probe will be placed approximately 3 cm lateral to the T10 spinous process, in the parasagittal plane. With the in-plane technique, when the block needle rests on the transverse process (approximately 3cm in depth), the erector spina plan will be confirmed with a 0.5-1 mL 0.9% NaCl test dose. 20 ml of local anesthetic mixture will be applied to the confirmed area. The procedure will be applied bilaterally. |
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)
- Female patients who will undergo hysterectomy under elective conditions
- 18- 65 years
- ASA I-II patients
Key exclusion criteria (9 listed)
- Refusal during registration, request to be excluded from the study, failure to give informed consent
- Under 18 years old and upper 65 years old
- ASA III-IV patients
- Chronic opioid use
- Presence of infection at the injection site
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 blockBilateral tap block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each | Procedure or surgery | tap block |
| ESP blockBilateral esp block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each | Procedure or surgery | esp block |
Primary outcome
Quality of Recovery 40 Questionnaire
Time frame: 24 hours after surgery.
The global Quality of Recovery-40 aggregate score is a scale from (1 to 5, where: 1 = very poor and 5 = excellent)
1 secondary outcome
Postoperative pain
Time frame: 24 hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Results publication: PubMed 29944049Yap JY, Bhat M, McMullen W, Ragupathy K. Novel use of laparoscopic-guided TAP block in total laparoscopic hysterectomy. J Obstet Gynaecol. 2018 Jul;38(5):736. doi: 10.1080/01443615.2018.1444402.
- Results publication: PubMed 33561705Rosato C, Santonastaso DP, de Chiara A, Viola L, Russo E, Piccioni FG, Agnoletti V. Erector spinae plane block for pain management in laparoscopic hysterectomy and bilateral oophorectomy. J Clin Anesth. 2021 Jun;70:110184. doi: 10.1016/j.jclinane.2021.110184. Epub 2021 Feb 6. No abstract available.
- Results publication: PubMed 32565029Yagi K, Adachi K, Tanaka E, Toda A, Miyoshi Y, Funada R, Yamamoto Y. The Role of Preoperative and Postoperative Transversus Abdominis Plane and Rectus Sheath Block in Patients Undergoing Total Laparoscopic Hysterectomy. J Perianesth Nurs. 2020 Oct;35(5):491-495. doi: 10.1016/j.jopan.2020.02.014. Epub 2020 Jun 18.
- Erector spinae plane block for pain management in laparoscopic hysterectomy and bilateral oophorectomyLink provided by the sponsor.
- The Role of Preoperative and Postoperative Transversus Abdominis Plane and Rectus Sheath Block in Patients Undergoing Total Laparoscopic HysterectomyLink provided by the sponsor.
- Novel use of laparoscopic-guided TAP block in total laparoscopic hysterectomyLink provided by the sponsor.
- 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.
pelin dilsiz eker, MD principal investigator
Mentese State Hospital
Ismail Gökbel, MD study chair
Mentese State Hospital
Sinem Sari Ozturk, MD study director
Aydin Adnan Menderes University, Department of anesthesiology and reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block and ESP block in people with Post Operative Pain, run by Mentese State 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 9 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pelin dilsiz eker, MD (05378401872, pelin.dlsz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery 40 Questionnaire (time frame: 24 hours after surgery.). 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 NCT05780333, 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 27 Mar 2023.