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

NCT ID: NCT05780333

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-27
• Study Completion Date: 2023-07-01

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tap block

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.

Group Type: OTHER

TAP block

Intervention Type: PROCEDURE

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

esp block

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.

Group Type: ACTIVE_COMPARATOR

ESP block

Intervention Type: PROCEDURE

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

Interventions

TAP block

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

Intervention Type: PROCEDURE

ESP block

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mentese State Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Pelin Dilsiz Eker

MD., specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

pelin dilsiz eker, MD

Role: PRINCIPAL_INVESTIGATOR

Mentese State Hospital

Ismail Gökbel, MD

Role: STUDY_CHAIR

Mentese State Hospital

Sinem Sari Ozturk, MD

Role: STUDY_DIRECTOR

Aydin Adnan Menderes University, Department of anesthesiology and reanimation

Locations

Pelin Dilsiz Eker

Muğla, Menteşe, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Pelin dilsiz eker, MD

Role: CONTACT

pelin.dlsz@hotmail.com

05378401872

Facility Contacts

pelin dilsiz eker, MD

Role: primary

pelin.dlsz@hotmail.com

05378401872

References

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.

Reference Type: RESULT

PMID: 29944049 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33561705 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32565029 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form: Informed Consent Form / ESP arm

View Document

Document Type: Informed Consent Form: Informed Consent Form / TAP arm

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/33561705/

Erector spinae plane block for pain management in laparoscopic hysterectomy and bilateral oophorectomy

https://pubmed.ncbi.nlm.nih.gov/32565029/

The Role of Preoperative and Postoperative Transversus Abdominis Plane and Rectus Sheath Block in Patients Undergoing Total Laparoscopic Hysterectomy

https://pubmed.ncbi.nlm.nih.gov/29944049/

Novel use of laparoscopic-guided TAP block in total laparoscopic hysterectomy

Other Identifiers

2022/12

Identifier Type: -

Identifier Source: org_study_id