TAP vs. ESP Block for Gynecological Post Operative Pain

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

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?

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Nerve Block
• Intervention / Treatment: Procedure: Transversus Abdominis Plane Block using 0.25% Bupivacaine; Procedure: Erector Spinae Plane Block using 0.25% Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Bandung, West Java, Indonesia
      • Hasan Sadikin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total postoperative morphine requirements	The total amount of morphine required by study subjects over 24 hours to reduce postoperative pain	24 hours post operative
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	24 hours post operative

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Study Director: Doddy M Tavianto, MD, Faculty of Medicine Universitas Padjadjaran Bandung; Study Director: Osmond M Pison, MD, Faculty of Medicine Universitas Padjadjaran Bandung; Principal Investigator: Azka P Rakhimulllah, MD, Faculty of Medicine Universitas Padjadjaran Bandung

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2022
• Primary Completion (Actual): March 26, 2023
• Study Completion (Actual): March 26, 2023

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: September 17, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Pain; Transversus Abdominis Plane Block; Erector Spinae Plane Block; Gynecological Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: AN-202309.03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No