Clinical trial NCT06044779: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Pain, Postoperative
Keywords: Transversus Abdominis Plane Block
Erector Spinae Plane Block
Postoperative Pain
Gynecological Surgery
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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?


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.

Primary outcomes:
measure: Postoperative Numerical Rating Scale
timeFrame: 24 hours post operative
Secondary outcomes:
measure: Total postoperative morphine requirements
timeFrame: 24 hours post operative
measure: Time of first need for analgesic rescue
timeFrame: 24 hours post operative
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Doddy M Tavianto, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Osmond M Pison, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Azka P Rakhimulllah, MD
role: PRINCIPAL_INVESTIGATOR
References: