Skip to main content
Clinical Trials/NCT06044779
NCT06044779
Completed
Not Applicable

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

Universitas Padjadjaran1 site in 1 country40 target enrollmentDecember 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nerve Block
Sponsor
Universitas Padjadjaran
Enrollment
40
Locations
1
Primary Endpoint
Postoperative Numerical Rating Scale
Status
Completed
Last Updated
2 years ago

Overview

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?
Registry
clinicaltrials.gov
Start Date
December 27, 2022
End Date
March 26, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Postoperative Numerical Rating Scale

Time Frame: 24 hours post operative

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 Outcomes

  • Time of first need for analgesic rescue(24 hours post operative)
  • Total postoperative morphine requirements(24 hours post operative)

Study Sites (1)

Loading locations...

Similar Trials