US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05272280

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Other: External oblique intercostal (EOI) block Other: Erector spinae plane block (ESPB)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

triple

Primary Purpose:

Prevention

Official Title:

Ultrasound Guided External Oblique Intercostal (EOI) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia in Laparoscopic Cholecystectomy

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: External oblique intercostal (EOI) block	Other: External oblique intercostal (EOI) block A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.
Active Comparator: Erector spinae plane block (ESPB)	Other: Erector spinae plane block (ESPB) A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of Local Anesthetic mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.

Arm

Intervention/Treatment

Active Comparator: External oblique intercostal (EOI) block

Other: External oblique intercostal (EOI) block

A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.

Active Comparator: Erector spinae plane block (ESPB)

Other: Erector spinae plane block (ESPB)

A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of Local Anesthetic mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.

Outcome Measures

Primary Outcome Measures

Nalbuphine consumption in mg equivalent to morphine dose. [24 hours postoperatively]
mg

Secondary Outcome Measures

Numerical Rating Scale (NRS) at rest and when coughing [at 1, 2,4 , 8, 16 and 24 hours postoperatively]
11-point scale where 0=no pain and 10=worst pain
Analgesic drug consumption other than nalbuphine [24 hours postoperatively]
in mg
Heart Rate [Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery]
beats /min
Mean Arterial Pressure [Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery]
mmHg
Incidence of Postoperative nausea & vomiting (PONV) [24 hours postoperatively]
Number of patients developing PONV
Shoulder pain [24 hours postoperatively]
Number of patients developing Shoulder pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
patients with the American Society of Anesthesiologists (ASA) physical status I/II,
Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

Allergy to local anaesthetics,
Infection at the site of injection,
Coagulopathy,
Chronic pain syndromes,
Prolonged opioid medication,
Patients who received any analgesic 24 h before surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University hospital	Assiut	Assiut, Asyut Governorate, Egypt,	Egypt

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Magdy Mohammed Mahdy Sayed, Doctor, Assiut University

ClinicalTrials.gov Identifier:

NCT05272280

Other Study ID Numbers:

ABC-5-DE

First Posted:

Mar 9, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Magdy Mohammed Mahdy Sayed, Doctor, Assiut University

Cholecystectomy

EOI block

ESP block

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jun 2, 2022