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

NCT ID: NCT04941170

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-29
• Study Completion Date: 2021-12-15

Brief 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.

Detailed 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.

Conditions

Pain; Hernia, Umbilical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group (T)

receive preoperative bilateral ultrasound-guided oblique subcostal transversus abdominis plane block.

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Group (E)

receive preoperative bilateral ultrasound-guided erector spinae plane block.

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

oblique subcostal transversus abdominis plane block; erector spinae plane block

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Ahmed Abdel Fatah

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

fatma ah abdelfatah, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

Banha Faculity of Medicine

Banhā, Elqalyoubea, Egypt

Countries

Egypt

Other Identifiers

RC 2-6-2021

Identifier Type: -

Identifier Source: org_study_id