TAP vs. ESP Block for Gynecological Post Operative Pain

• ClinicalTrials.gov Identifier: NCT06044779
• Recruitment Status: Completed
• First Posted: September 21, 2023
• Last Update Posted: September 22, 2023
• Sponsor: Universitas Padjadjaran
• Information provided by (Responsible Party): Universitas Padjadjaran

Study Description

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?

Condition or disease	Intervention/treatment	Phase
Nerve Block; Pain, Postoperative	Procedure: Transversus Abdominis Plane Block using 0.25% Bupivacaine; Procedure: Erector Spinae Plane Block using 0.25% Bupivacaine	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Other
• Official 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
• Actual Study Start Date: December 27, 2022
• Actual Primary Completion Date: March 26, 2023
• Actual Study Completion Date: March 26, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Indonesia

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Sponsors and Collaborators

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

More Information

• Responsible Party: Universitas Padjadjaran
• ClinicalTrials.gov Identifier: NCT06044779
• Other Study ID Numbers: AN-202309.03
• First Posted: September 21, 2023
• Last Update Posted: September 22, 2023
• Last Verified: September 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitas Padjadjaran:

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

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents