TAP vs. ESP Block for Gynecological Post Operative Pain

NCT06044779 | Completed DMC

• 1 other identifier: AN-202309.03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Nerve Block; Pain, Postoperative

Keywords

Transversus Abdominis Plane Block; Erector Spinae Plane Block; Postoperative Pain; Gynecological Surgery

Outcome Measures

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

  24 hours post operative

Secondary Outcomes (2)

• Total postoperative morphine requirements

  24 hours post operative

• Time of first need for analgesic rescue

  24 hours post operative

Study Arms (2)

Transversus Abdominis Plane (TAP) Anesthestic Block

ACTIVE COMPARATOR

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

Erector Spinae Plane (ESP) Anesthetic Block

ACTIVE COMPARATOR

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

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.

Transversus Abdominis Plane (TAP) Anesthestic Block

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.

Erector Spinae Plane (ESP) Anesthetic Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Doddy M Tavianto, MD

  Faculty of Medicine Universitas Padjadjaran Bandung

  STUDY DIRECTOR

• Osmond M Pison, MD

  Faculty of Medicine Universitas Padjadjaran Bandung

  STUDY DIRECTOR

• Azka P Rakhimulllah, MD

  Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 21, 2023
• Study Start: December 27, 2022
• Primary Completion: March 26, 2023
• Study Completion: March 26, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

ID (1)