External Oblique Intercostal Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Adult Patients Undergoing Open Nephrectomy

Postoperative Analgesia Clinical Trial

Official title:

External Oblique Intercostal Plane Block Versus Ultrasound Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Adult Patients Undergoing Open Nephrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452238
• Other study ID #: 36264PR639/4/24
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Tanta University
• Contact: Mohammed S ElSharkawy, MD
• Phone: 00201148207870
• Email: mselsharkawy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare external oblique intercostal plane (EOIP) block and ultrasound guided transversus abdominis plane (TAP) Block for postoperative analgesia in adult patients undergoing open nephrectomy.

Description:

Patients undergoing nephrectomy have a high incidence of postoperative pain despite the use of modern laparoscopic surgical techniques. In the postoperative period, these patients are often treated with patient-controlled opioids, epidural analgesia, or both.

Ultrasound-guided transversus abdominis plane (TAP) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. Studies have confirmed that ultrasound-guided (USG) transversus abdominis plane (TAP) block is an effective method of analgesia for upper abdominal surgeries, lower abdominal surgeries, and kidney transplantation, with minimal side effects.

External oblique intercostal plane block (EOIPB) has been reported by Elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , The advantage of EOIPB is that it may be performed with the patient supine. Furthermore, in comparison to serratus intercostal plane block (SIPB), it generates more extensive analgesic effects throughout the whole midline of the abdomen .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Both sexes.

• American Society of Anesthesiology (ASA) physical status I-II.

• Scheduled for open nephrectomy.

Exclusion Criteria:

• Bleeding disorders.

• Skin lesions or infection at the site of proposed needle insertion.

• Allergy to local anesthetics.

• Neurological disorders.

• Drug abuse.

• BMI > 30 kg/m2.

• Pregnancy.

• Diabetic neuropathy.

• Severe cardiovascular problems.

Related Conditions & MeSH terms

• Nephrectomy
• Postoperative Analgesia
• Transversus Abdominis Plane Block

Intervention

Other:
• External Oblique Intercostal Plane Block
Patients will receive external oblique intercostal plane block .
• Transversus Abdominis Plane Block
Patients will receive ultrasound-guided transversus abdominis plane block.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total pethidine consumption in the 1st 24hr	A standardized analgesic regimen will be prescribed in the postoperative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of pethidine will be given as 2 mg bolus if the Numerical Rating Scale (NRS) > 3 to be repeated after 30 min if pain persists until the Numerical Rating Scale (NRS) < 4. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.	24 hours postoperatively
Secondary	Intraoperative fentanyl consumption	Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).	Intraoperatively
Secondary	Time to the 1st rescue analgesia.	A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of pethidine will be given as 2 mg bolus if the Numerical Rating Scale (NRS) > 3 to be repeated after 30 min if pain persists until the Numerical Rating Scale (NRS) < 4. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.; It will be measured from the end of surgery to first dose of pethidine administrated.	24 hours postoperatively
Secondary	Degree of pain	Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.	24 hours postoperatively
Secondary	Mean arterial pressure	It will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Every 15 minutes till the end of surgery
Secondary	Heart rate	It will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Every 15 minutes till the end of surgery