TAP vs. ESP Block for Gynecological Post Operative Pain

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06044779
• Other study ID #: AN-202309.03
• Status: Completed
• Phase: N/A
• Start date: December 27, 2022
• Est. completion date: March 26, 2023

Study information

• Verified date: September 2023
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 26, 2023
• Est. primary completion date: March 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nerve Block
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Hasan Sadikin General Hospital	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total postoperative morphine requirements	The total amount of morphine required by study subjects over 24 hours to reduce postoperative pain	24 hours post operative
Secondary	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