Back to resultsTAP vs. ESP Block for Gynecological Post Operative Pain
Primary Purpose
Nerve Block, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Transversus Abdominis Plane Block using 0.25% Bupivacaine
Erector Spinae Plane Block using 0.25% Bupivacaine
Sponsored by
About this trial
This is an interventional other trial for Nerve Block focused on measuring Transversus Abdominis Plane Block, Erector Spinae Plane Block, Postoperative Pain, Gynecological Surgery
Eligibility Criteria
Inclusion Criteria: Subjects with gynecological surgery techniques with a median incision include: hysterectomy, myomectomy, salpingectomy, ovarectomy and ovarian cystectomy. Subjects with physical status based on the American Society of Anesthesiologists (ASA) in categories I-II Subjects who are willing to sign informed consent form. Exclusion Criteria: The patient has a history of allergies to local anesthetic drugs used for TAP blockade or ESP blockade and is allergic to morphine. Patients who have skin infections at the injection site. Patients with a history of chronic pain, namely a history of pain for more than 1 month obtained from history taking. Patients with a history of chronic pain treatment obtained from history taking. Patients with impaired kidney function (Ureum >39 mg/dL; Creatinine >1.3 mg/dL) and liver (SGOT >37 U/L; SGPT >59 U/L), myopathy, coagulopathy obtained from the results of supporting examinations, heart rhythm disorders obtained from the results of an EKG examination and neurological disorders in the form of hypesthesia or paraesthesia obtained from the results of a physical examination in the form of a sensory examination. The patient is pregnant as determined by history taking. Patients who are illiterate as obtained from history taking. The patient was uncooperative during examination.
Sites / Locations
- Hasan Sadikin General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transversus Abdominis Plane (TAP) Anesthestic Block
Erector Spinae Plane (ESP) Anesthetic Block
Arm Description
Ultrasound-guided TAP block is done using 20 mL of 0.25% Bupivacaine administered at the lateral abdominal wall between the costal margin and the iliac crest
Ultrasound-guided ESP block is done using 20 mL of 0.25% Bupivacaine administered at the tip of the transverse process at the T9 level
Outcomes
Primary Outcome Measures
Postoperative Numerical Rating Scale
The degree of pain assessment is classified based on the Numeric Rating Scale pain assessment scale) with the lowest scale being no pain (value 0), up to the heaviest pain scale (value 10) when still, namely when the patient does not make any movement and moves, namely when mobilization is carried out on the left side and right tilt
Secondary Outcome Measures
Total postoperative morphine requirements
The total amount of morphine required by study subjects over 24 hours to reduce postoperative pain
Time of first need for analgesic rescue
The time required by study subjects to press the PCA to obtain analgesics was first calculated from the time it was installed in the recovery room
Full Information
NCT ID
NCT06044779
First Posted
September 10, 2023
Last Updated
September 21, 2023
Sponsor
Universitas Padjadjaran
1. Study Identification
Unique Protocol Identification Number
NCT06044779
Brief Title
TAP vs. ESP Block for Gynecological Post Operative Pain
Official Title
Transversus Abdominis Plane (TAP) Block and Erector Spinae Plane (ESP) Block Comparison on Postoperative Pain and the Need for Morphine in Gynecological Surgery Patients Who Underwent Median Incision in Hasan Sadikin General Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
March 26, 2023 (Actual)
Study Completion Date
March 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitas Padjadjaran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this double blind randomized controlled trial is to compare transversus abdominis plane block and erector spinae plane block in gynecological surgery patients. The main questions it aims to answer are:
What are the numerical post-operative pain scores in these two groups?
Is there any significant difference in the numerical post-operative pain scores between subjects who underwent TAP block and subjects who underwent ESP block?
What are the differences in the time needed for additional morphine in these two groups?
Is there any significant differences in the time needed for additional morphine between subjects who underwent TAP block and subjects who underwent ESP block?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Block, Pain, Postoperative
Keywords
Transversus Abdominis Plane Block, Erector Spinae Plane Block, Postoperative Pain, Gynecological Surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transversus Abdominis Plane (TAP) Anesthestic Block
Arm Type
Active Comparator
Arm Description
Ultrasound-guided TAP block is done using 20 mL of 0.25% Bupivacaine administered at the lateral abdominal wall between the costal margin and the iliac crest
Arm Title
Erector Spinae Plane (ESP) Anesthetic Block
Arm Type
Active Comparator
Arm Description
Ultrasound-guided ESP block is done using 20 mL of 0.25% Bupivacaine administered at the tip of the transverse process at the T9 level
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominis Plane Block using 0.25% Bupivacaine
Intervention Description
TAP block regional anesthesia with ultrasound guidance with administration of 20 mL of 0.25% Bupivacaine in the abdominal wall before the operation is completed. The patient was also fitted with a morphine PCA device with a background dose of 5 µg/kgBW/hour and a rescue dose of 1 mg with a lockout interval of 10 minutes.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block using 0.25% Bupivacaine
Intervention Description
Regional anesthesia ESP block under ultrasound guidance with 20 mL of 0.25% bupivacaine at the tip of the transverse process at the T9 level before completion of surgery. The patient was also fitted with a morphine PCA device with a background dose of 5 µg/kgBW/hour and a rescue dose of 1 mg with a lockout interval of 10 minutes.
Primary Outcome Measure Information:
Title
Postoperative Numerical Rating Scale
Description
The degree of pain assessment is classified based on the Numeric Rating Scale pain assessment scale) with the lowest scale being no pain (value 0), up to the heaviest pain scale (value 10) when still, namely when the patient does not make any movement and moves, namely when mobilization is carried out on the left side and right tilt
Time Frame
24 hours post operative
Secondary Outcome Measure Information:
Title
Total postoperative morphine requirements
Description
The total amount of morphine required by study subjects over 24 hours to reduce postoperative pain
Time Frame
24 hours post operative
Title
Time of first need for analgesic rescue
Description
The time required by study subjects to press the PCA to obtain analgesics was first calculated from the time it was installed in the recovery room
Time Frame
24 hours post operative
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with gynecological surgery techniques with a median incision include: hysterectomy, myomectomy, salpingectomy, ovarectomy and ovarian cystectomy.
Subjects with physical status based on the American Society of Anesthesiologists (ASA) in categories I-II
Subjects who are willing to sign informed consent form.
Exclusion Criteria:
The patient has a history of allergies to local anesthetic drugs used for TAP blockade or ESP blockade and is allergic to morphine.
Patients who have skin infections at the injection site.
Patients with a history of chronic pain, namely a history of pain for more than 1 month obtained from history taking.
Patients with a history of chronic pain treatment obtained from history taking.
Patients with impaired kidney function (Ureum >39 mg/dL; Creatinine >1.3 mg/dL) and liver (SGOT >37 U/L; SGPT >59 U/L), myopathy, coagulopathy obtained from the results of supporting examinations, heart rhythm disorders obtained from the results of an EKG examination and neurological disorders in the form of hypesthesia or paraesthesia obtained from the results of a physical examination in the form of a sensory examination.
The patient is pregnant as determined by history taking.
Patients who are illiterate as obtained from history taking.
The patient was uncooperative during examination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doddy M Tavianto, MD
Organizational Affiliation
Faculty of Medicine Universitas Padjadjaran Bandung
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Osmond M Pison, MD
Organizational Affiliation
Faculty of Medicine Universitas Padjadjaran Bandung
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Azka P Rakhimulllah, MD
Organizational Affiliation
Faculty of Medicine Universitas Padjadjaran Bandung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Sadikin General Hospital
City
Bandung
State/Province
West Java
Country
Indonesia
12. IPD Sharing Statement
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TAP vs. ESP Block for Gynecological Post Operative Pain
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