- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06007378
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
February 16, 2026 updated by: Ibrahim Mamdouh Esmat, Ain Shams University
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery by Supplementing Ultrasound-guided Erector Spinae Plane Block With Ketamine or Transdermal Fentanyl Patch
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Ain-Shams University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Bupivacaine and ketamine
|
Bilateral erector spinae plane block (bupivacaine and ketamine)
|
|
Other: Bupivacaine and transdermal fentanyl patch
|
Bilateral erector spinae plane block (bupivacaine) and transdermal fentanyl patch
|
|
Other: Bupivacaine
|
Bilateral erector spinae plane block (bupivacaine)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The time to first rescue analgesia after surgery (hour)
Time Frame: The first 48 hours after surgery
|
The time to first rescue analgesia after surgery (hour)
|
The first 48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2023
Primary Completion (Actual)
July 22, 2025
Study Completion (Actual)
July 22, 2025
Study Registration Dates
First Submitted
August 17, 2023
First Submitted That Met QC Criteria
August 17, 2023
First Posted (Actual)
August 23, 2023
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 16, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Organic Chemicals
- Hydrocarbons
- Cyclohexanes
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Anilides
- Amides
- Aniline Compounds
- Amines
- Bupivacaine
- Ketamine
Other Study ID Numbers
- FMASU MS 416 / 2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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