U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Preemptive Analgesia

Pain Clinical Trial

Official title:

U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Pre-emptive Analgesia for Open Umbilical Hernia Repair; Randomized, Double-blinded Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941170
• Other study ID #: RC 2-6-2021
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: May 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Administration of opioids for the treatment of acute pain after open umbilical hernia repair is associated with many side effects. Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region.TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen.

Description:

TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique and decreases postoperative pain and opioid consumption.

Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region. However, its first use was for the treatment of chronic pain, but recently it has been used as a postoperative regional analgesia technique in different surgeries from the shoulder to hip regions (3-4) The present study will be carried out to compare the preemptive analgesic efficacy between the ultrasound-guided bilateral ESP block versus bilateral oblique subcostal TAP block on patients undergoing open umbilical hernia repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 15, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. American Society of anesthesiologists I-II, scheduled for open umbilical hernia repair.

2. Age range of 18-65 years.

Exclusion Criteria:

1. patient refusal.

2. Patients belonging to ASA grade III and grade IV.

3. Extreme obesity (BMI >35).

4. hepatic or renal insufficiency.

5. preoperative cognitive dysfunction or communication disorder.

6. allergy to amide-type local anaesthetics.

7. back puncture site infection.

8. Coagulation disorders, pregnancy, drug abusers.

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Pain

Intervention

Drug:
• Bupivacain
Ultrasound-guided oblique subcostal transversus abdominis plane block will be performed in the supine position under strict aseptic precautions. placing a linear high-frequency ultrasound probe obliquely near the costal margin and xiphoid process On confirming the placement of the needle in the correct target space, 1 mL of 0.25% bupivacaine will be injected to hydro-dissect the fascia layer between the RA and TA. After confirming the separation of the transversus abdominis fascia plane, the remaining 19 mL of 0.25% bupivacaine will be administered, advancing the needle infero-laterally parallel to the subcostal margin. A similar procedure will be performed on the contralateral side of the abdomen with an injection of another 20 mL of 0.25% bupivacaine.
• Bupivacaine
Ultrasound-guided erector spinae plane block will be performed in the sitting position. T7 spinous process will be located To perform the block. The tip of the T7 transverse process will be then identified using the ultrasound probe that is placed in a transverse orientation The ultrasound transducer will then be placed in a longitudinal orientation 2-3 cm lateral to the midline in a longitudinal orientation to identify the hyperechoic line of the transverse process with its associated acoustic shadow. After local anaesthetic infiltration, the block needle will be inserted in a craniocaudal direction until contact will be achieved with the T 7 transverse process where the tip will lay in the inter-fascial plane below the erector spinae muscle. A small bolus of local anaesthetic should be given through the block needle to confirm the proper needle position. A total of 20 mL bupivacaine 0.25% will be injected into the interfacial plane deep to the erector spinae muscle bilaterally.

Locations

Country	Name	City	State
Egypt	Banha Faculity of Medicine	Banha	Elqalyoubea

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total morphine consumption.	Amount of morphine used as rescue analgesia post-operatively.	in first 24 hours
Secondary	Intraoperative fentanyl consumption	Intraoperative fentanyl dosage (µg)	From the start of operation till its end up to 3 hours.
Secondary	time of first analgesic request	first time of analgesia used after operation.	in 24 hours
Secondary	pain severity evaluation.	by verbal numerical rating scale (VNRS) at rest and cough (0 = no pain, 10 = unbearable pain).	at PACU admission , 30 minutes , 2 hours , 4 hours , 8 hours ,12 hours ,18 hours and 24 hours post operative