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CompletedNCT06044779Updated Sep 22, 2023

TAP vs. ESP Block for Gynecological Post Operative Pain

An interventional study of Transversus Abdominis Plane Block using 0.25% Bupivacaine and Erector Spinae Plane Block using 0.25% Bupivacaine in Nerve Block and Pain, Postoperative, sponsored by Universitas Padjadjaran. Completed at 1 site in Indonesia. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Universitas Padjadjaran · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2022, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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?
02

Conditions studied

  • Nerve Block
  • Pain, Postoperative

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Keywords

  • Transversus Abdominis Plane Block
  • Erector Spinae Plane Block
  • Postoperative Pain
  • Gynecological Surgery
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 40 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Universitas Padjadjaran is the lead sponsor of 90 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Transversus Abdominis Plane (TAP) Anesthestic Block

    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

    Procedure: Transversus Abdominis Plane Block using 0.25% Bupivacaine

  • Active comparator
    Erector Spinae Plane (ESP) Anesthetic Block

    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

    Procedure: Erector Spinae Plane Block using 0.25% Bupivacaine

Interventions

  • ProcedureTransversus Abdominis Plane Block using 0.25% Bupivacaine

    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.

  • ProcedureErector Spinae Plane Block using 0.25% Bupivacaine

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours post operative

Secondary outcomes

  1. Total postoperative morphine requirements

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

    Time frame: 24 hours post operative

  2. 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

    Time frame: 24 hours post operative

07

Study locations

1 site
  • Hasan Sadikin General Hospital
    Bandung, West Java, Indonesia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06044779
Lead sponsor
Universitas Padjadjaran
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Dec 27, 2022
Primary completion
Mar 26, 2023
Completion
Mar 26, 2023
Last update
Sep 22, 2023

Study contacts

Doddy M Tavianto, MD
study director · Faculty of Medicine Universitas Padjadjaran Bandung
Osmond M Pison, MD
study director · Faculty of Medicine Universitas Padjadjaran Bandung
Azka P Rakhimulllah, MD
principal investigator · Faculty of Medicine Universitas Padjadjaran Bandung

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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