TAP vs. ESP Block for Gynecological Post Operative Pain

Not Applicable

Completed

• Conditions: Pain, Postoperative; Nerve Block
• Interventions: Procedure: Transversus Abdominis Plane Block using 0.25% Bupivacaine; Procedure: Erector Spinae Plane Block using 0.25% Bupivacaine

• Registration Number: NCT06044779
• Lead Sponsor: Universitas Padjadjaran

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-27
• Primary Completion: 2023-03-26
• Study Completion: 2023-03-26
• Status Verified: 2023-09
• Study First Submitted: 2023-09-10
• Study First Submitted QC: 2023-09-17
• Study First Posted: 2023-09-21
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus Abdominis Plane (TAP) Anesthestic Block	Transversus Abdominis Plane Block using 0.25% Bupivacaine	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
Erector Spinae Plane (ESP) Anesthetic Block	Erector Spinae Plane Block using 0.25% Bupivacaine	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

Primary Outcome Measures

Name	Time	Method
Postoperative Numerical Rating Scale	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 Outcome Measures

Name	Time	Method
Time of first need for analgesic rescue	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
Total postoperative morphine requirements	24 hours post operative	The total amount of morphine required by study subjects over 24 hours to reduce postoperative pain

Trial Locations

Locations (1)

Hasan Sadikin General Hospital; 🇮🇩 Bandung, West Java, Indonesia