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OpenTrials
Completed

NCT Number: NCT06044779

TAP vs. ESP Block for Gynecological Post Operative Pain

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?

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transversus Abdominis Plane Block using 0.25% Bupivacaine

Procedure

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.

Erector Spinae Plane Block using 0.25% Bupivacaine

Procedure

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 outcomes

  1. 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

  1. Total postoperative morphine requirements

    Time frame: 24 hours post operative

    The total amount of morphine required by study subjects over 24 hours to reduce postoperative pain

  2. Time of first need for analgesic rescue

    Time frame: 24 hours post operative

    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

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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