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

Phase 4

Completed

• Conditions: Pain; Hernia, Umbilical
• Interventions: Drug: Bupivacain; Drug: Bupivacaine

• Registration Number: NCT04941170
• Lead Sponsor: Benha University

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.

Study Timeline

• Study First Submitted: 2021-06-19
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-06-28
• Study Start: 2021-06-29
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (T)	Bupivacain	receive preoperative bilateral ultrasound-guided oblique subcostal transversus abdominis plane block.
Group (E)	Bupivacain	receive preoperative bilateral ultrasound-guided erector spinae plane block.
Group (T)	Bupivacaine	receive preoperative bilateral ultrasound-guided oblique subcostal transversus abdominis plane block.
Group (E)	Bupivacaine	receive preoperative bilateral ultrasound-guided erector spinae plane block.

Primary Outcome Measures

Name	Time	Method
total morphine consumption.	in first 24 hours	Amount of morphine used as rescue analgesia post-operatively.

Secondary Outcome Measures

Name	Time	Method
time of first analgesic request	in 24 hours	first time of analgesia used after operation.
pain severity evaluation.	at PACU admission , 30 minutes , 2 hours , 4 hours , 8 hours ,12 hours ,18 hours and 24 hours post operative	by verbal numerical rating scale (VNRS) at rest and cough (0 = no pain, 10 = unbearable pain).
Intraoperative fentanyl consumption	From the start of operation till its end up to 3 hours.	Intraoperative fentanyl dosage (μg)

Trial Locations

Locations (1)

Banha Faculity of Medicine; 🇪🇬 Banha, Elqalyoubea, Egypt