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NCT06007378 Clinical Trial

Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery

Postoperative Pain Clinical Trial

Official title:
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery by Supplementing Ultrasound-guided Erector Spinae Plane Block With Ketamine or Transdermal Fentanyl Patch

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06007378
Other study ID # FMASU MS 416 / 2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 5, 2023
Est. completion date September 30, 2024

Study information
Verified date June 2024
Source Ain Shams University
Contact Ibrahim Mamdouh Esmat
Phone 01001241928
Email ibrahim_mamdouh@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Erector spinae plane block (ESPB) is a novel regional block technique that was proven to have superior outcomes in relieving postoperative pain in colorectal surgeries.Ketamine enhances the impact of local anaesthetics by reducing the duration and extent of motor block while shortening the onset of sensory and motor block.Transdermal Fentanyl Patch (TFP) was better than transdermal buprenorphine in postoperative analgesia following abdominal surgeries.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Patients undergoing laparoscopic colorectal surgery. - American Society of Anesthesiologists (ASA) physical status I or II. Exclusion Criteria: - Known allergy to one of the study medications. - Skin infections at the site of the needle puncture. - Hepatic, renal or cardiac dysfunction. - Patients diagnosed with obstructive sleep apnoea

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Bupivacaine and ketamine
Bilateral erector spinae plane block (bupivacaine and ketamine)
• Bupivacaine and transdermal fentanyl patch
Bilateral erector spinae plane block (bupivacaine) and transdermal fentanyl patch
• Bupivacain
Bilateral erector spinae plane block (bupivacaine)

Locations
Country Name City State
Egypt Ain-Shams University Hospitals Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The total rescue analgesia consumption (mg) The total rescue analgesia consumption (mg) in the first 48 hours after surgery in the first 48 hours after surgery
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