Effect of Different Plane Blocks on Quality of Recovery and Postoperative Pain After Laparoscopic Hysterectomy

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780333
• Other study ID #: 2022/12
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2023
• Source: Mentese State Hospital
• Contact: Pelin dilsiz eker, MD
• Phone: 05378401872
• Email: pelin.dlsz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 - will fill out the postoperative questionnaire - will report their pain status according to the NRS score

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• TAP block
Bilateral tap block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each
• ESP block
Bilateral esp block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each

Locations

Country	Name	City	State
Turkey	Pelin Dilsiz Eker	Mugla	Mentese

Sponsors (1)

Lead Sponsor	Collaborator
Mentese State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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.2021.110 — View 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):4 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	using salvage opiod	Additional opioid use for nrs score of 4 and above	24 hours after surgery.
Primary	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.
Secondary	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.

External Links

•   Erector spinae plane block for pain management in laparoscopic hysterectomy and bilateral oophorectomy
•   Novel use of laparoscopic-guided TAP block in total laparoscopic hysterectomy
•   The Role of Preoperative and Postoperative Transversus Abdominis Plane and Rectus Sheath Block in Patients Undergoing Total Laparoscopic Hysterectomy