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

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TAP block
ESP block
Sponsored by
Mentese State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring tap block, esp block, postoperative pain, recovery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pelin Dilsiz EkerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

tap block

esp block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Postoperative pain
is a numerical rating scale from (1 to 10, where: 1 is the mildest and 10 the worst possible)

Full Information

First Posted
March 4, 2023
Last Updated
March 23, 2023
Sponsor
Mentese State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05780333
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mentese State Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
tap block, esp block, postoperative pain, recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a double blind, randomized control clinical trial.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Triple (Participant, Care Provider, Investigator)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tap block
Arm Type
Other
Arm Description
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.
Arm Title
esp block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
Bilateral tap block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each
Intervention Type
Procedure
Intervention Name(s)
ESP block
Intervention Description
Bilateral esp block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each
Primary Outcome Measure Information:
Title
Quality of Recovery 40 Questionnaire
Description
The global Quality of Recovery-40 aggregate score is a scale from (1 to 5, where: 1 = very poor and 5 = excellent)
Time Frame
24 hours after surgery.
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
is a numerical rating scale from (1 to 10, where: 1 is the mildest and 10 the worst possible)
Time Frame
24 hours after surgery.
Other Pre-specified Outcome Measures:
Title
using salvage opiod
Description
Additional opioid use for nrs score of 4 and above
Time Frame
24 hours after surgery.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
It will be planned for female gender as patients who have undergone hysterectomy will be selected.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pelin dilsiz eker, MD
Phone
05378401872
Email
pelin.dlsz@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
pelin dilsiz eker, MD
Organizational Affiliation
Mentese State Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ismail Gökbel, MD
Organizational Affiliation
Mentese State Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sinem Sari Ozturk, MD
Organizational Affiliation
Aydin Adnan Menderes University, Department of anesthesiology and reanimation
Official's Role
Study Director
Facility Information:
Facility Name
Pelin Dilsiz Eker
City
Muğla
State/Province
Menteşe
ZIP/Postal Code
48050
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
pelin dilsiz eker, MD
Phone
05378401872
Email
pelin.dlsz@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29944049
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.
Results Reference
result
PubMed Identifier
33561705
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.
Results Reference
result
PubMed Identifier
32565029
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/33561705/
Description
Erector spinae plane block for pain management in laparoscopic hysterectomy and bilateral oophorectomy
URL
https://pubmed.ncbi.nlm.nih.gov/32565029/
Description
The Role of Preoperative and Postoperative Transversus Abdominis Plane and Rectus Sheath Block in Patients Undergoing Total Laparoscopic Hysterectomy
URL
https://pubmed.ncbi.nlm.nih.gov/29944049/
Description
Novel use of laparoscopic-guided TAP block in total laparoscopic hysterectomy

Learn more about this trial

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

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