Transversus Abdominis Plane Block Versus Erector Spinae Plane Block

Postoperative Pain Clinical Trial

Official title:

Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Emergency Laparotomies.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989570
• Other study ID #: 73-7/2018
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: June 2020
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The TAP block, first described by Rafi in 2001, is comprised of deposition of a local anesthetic into the anatomical plane between the internal oblique and transverses abdominis muscles, where thess thoracoabdominal nerves (T6-L1) contribute to the main sensory supply of the skin, muscles, and parietal peritoneum of the anterior abdominal wall. These nerves branch and communicate extensively with each other in the TAP .

Erector spinae plane (ESP) block is a recently described interfascial block in which the local anaesthectic is placed over or below the plane of the erector spinae muscle, near where the spinal nerves come out from the spine before they start to divide. Some publications have shown its effectiveness in treating thoracic and abdominal postoperative pain.

Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism, respiratory complications and prolongs the hospital stay. Parietal pain is the chief component of postoperative pain after abdominal surgeries. Large doses of opioids are required to mitigate this pain, but they are poorly tolerated. Multimodal analgesia is effective in handling postoperative pain and in attenuating the side effects of large doses of a single analgesic .

Description:

Group I (A group): Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).

Group II (B group): Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).

Group III (C group): anesthetized with the protocol followed by Minia University Hospital The medication will be prepared and supplied in similar syringes by an anesthetist not included in the management of the patint or data collection.

Methods:

Following placement of the standard monitors, intravenous access will secured and the patients will started on IV fluids. Anesthesia will be induced with 0.04 mg/kg midazolam, 2 μg/kg fentanyl, and titrated doses of propofol. Endotracheal intubation will facilitated with 0.5 mg/kg of atracurium. Isoflurane 1.2%, will be used for anesthetic maintenance After induction of anesthesia, stabilizing the patient's hemodynamics, and before surgical incision, ESB & TAP block will be performed. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected. Then the patient will turn in lateral position, the site of the ultrasound and needle entry will be sterilized. The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 12, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1. Age18-70 . 2. Both gender . 3 .Emergency laparotomies . 4. ASA I-III .

Exclusion Criteria:

1. Drug allergy .

2. Morbid obesity (BMI >40 kg/m2) .

3. Psychiatric disorder .

4. Opioid dependence .

5. patient refuse

Related Conditions & MeSH terms

• Laparotomy
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• transversus abdominis plane block
The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
• erector spinae plane block
The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes

Other:
• control group
placebo

Locations

Country	Name	City	State
Egypt	Minia University Hospital	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Hassan Mokhtar Elshorbagy Hetta

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of First Post Operative Analgesic Request	the pain will be assisted based on the time for the first dose of rescue analgesia	24 hours
Primary	Postoperative Total Fentanyl Requirement	The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours	24 hours
Secondary	Incidence of Any Adverse Events	adverse events related to technique or drugs	5 days