Clinical trial NCT05780333: Effect of Different Plane Blocks on Quality of Recovery and Postoperative Pain After Laparoscopic Hysterectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Keywords: tap block
esp block
postoperative pain
recovery
Lead sponsor: Mentese State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double blind, randomized control clinical trial.
Primary purpose: TREATMENT

Brief 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
* 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.

Eligibility criteria: Inclusion Criteria:

* Female patients who will undergo hysterectomy under elective conditions
* 18- 65 years
* ASA I-II patients

Exclusion Criteria:

* 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
* Bupivacaine sensitivity
* Use of anticoagulants
* BMI \< 18,5 , BMI \>35

Primary outcomes:
measure: Quality of Recovery 40 Questionnaire
timeFrame: 24 hours after surgery.
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 hours after surgery.
Other outcomes:
measure: using salvage opiod
timeFrame: 24 hours after surgery.
Locations:
city: Muğla
country: Turkey
facility: Pelin Dilsiz Eker
state: Menteşe
Study officials:
affiliation: Mentese State Hospital
name: pelin dilsiz eker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mentese State Hospital
name: Ismail Gökbel, MD
role: STUDY_CHAIR
affiliation: Aydin Adnan Menderes University, Department of anesthesiology and reanimation
name: Sinem Sari Ozturk, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.