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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;
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP block | Procedure | Bilateral tap block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | is a numerical rating scale from (1 to 10, where: 1 is the mildest and 10 the worst possible) | 24 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| using salvage opiod | Additional opioid use for nrs score of 4 and above | 24 hours after surgery. |
Inclusion Criteria:
Exclusion Criteria:
It will be planned for female gender as patients who have undergone hysterectomy will be selected.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pelin dilsiz eker, MD | Contact | 05378401872 | pelin.dlsz@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| pelin dilsiz eker, MD | Mentese State Hospital | Principal Investigator |
| Ismail Gökbel, MD | Mentese State Hospital | Study Chair |
| Sinem Sari Ozturk, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pelin Dilsiz Eker | Recruiting | Muğla | Menteşe | 48050 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29944049 | Result | 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. | |
| 33561705 | Result | Rosato 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. |
| Label | URL |
|---|---|
| Erector spinae plane block for pain management in laparoscopic hysterectomy and bilateral oophorectomy | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form / ESP arm | Jan 21, 2023 | Mar 23, 2023 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form / TAP arm | Jan 21, 2023 | Mar 23, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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This is a double blind, randomized control clinical trial.
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Triple (Participant, Care Provider, Investigator)
| ESP block | Procedure | Bilateral esp block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each |
|
| Aydin Adnan Menderes University, Department of anesthesiology and reanimation |
| Study Director |
| 32565029 | Result | Yagi 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. |
| The Role of Preoperative and Postoperative Transversus Abdominis Plane and Rectus Sheath Block in Patients Undergoing Total Laparoscopic Hysterectomy | View source |
| Novel use of laparoscopic-guided TAP block in total laparoscopic hysterectomy | View source |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |