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

NCT05780333 | Unknown

• 1 other identifier: 2022/12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain

Keywords

tap block; esp block; postoperative pain; recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative pain

  24 hours after surgery.

Other Outcomes (1)

• using salvage opiod

  24 hours after surgery.

Study Arms (2)

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.

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.

Procedure: ESP block

Interventions

TAP block PROCEDURE

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

tap block

ESP block PROCEDURE

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

esp block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: It will be planned for female gender as patients who have undergone hysterectomy will be selected.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients who will undergo hysterectomy under elective conditions
• years
• ASA I-II patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Mentese State Hospital: lead

Study Sites (1)

Pelin Dilsiz Eker

Muğla, Menteşe, 48050, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 29944049 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.

  PMID: 33561705 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.

  PMID: 32565029 RESULT

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• pelin dilsiz eker, MD

  Mentese State Hospital

  PRINCIPAL INVESTIGATOR

• Ismail Gökbel, MD

  Mentese State Hospital

  STUDY CHAIR

• Sinem Sari Ozturk, MD

  Aydin Adnan Menderes University, Department of anesthesiology and reanimation

  STUDY DIRECTOR

Central Study Contacts

Pelin dilsiz eker, MD

CONTACT

05378401872; pelin.dlsz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple (Participant, Care Provider, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., specialist

Model Details: This is a double blind, randomized control clinical trial.

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 22, 2023
• Study Start: January 27, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 1, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)