Postoperative PainNCT06007378
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
A study testing Bupivacaine and ketamine, Bupivacaine and transdermal fentanyl patch and Bupivacain in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine and ketamine, Bupivacaine and transdermal fentanyl patch and Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2023to 22 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic colorectal surgery.
- American Society of Anesthesiologists (ASA) physical status I or II.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine and ketamine, Bupivacaine and transdermal fentanyl patch, Bupivacain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine and ketamineOther
Bilateral erector spinae plane block (bupivacaine and ketamine)
Bupivacaine and transdermal fentanyl patchOther
Bilateral erector spinae plane block (bupivacaine) and transdermal fentanyl patch
BupivacainOther
Bilateral erector spinae plane block (bupivacaine)
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine and ketamine | Other | Not described Receives: Other: Bupivacaine and ketamine |
| Bupivacaine and transdermal fentanyl patch | Other | Not described Receives: Other: Bupivacaine and transdermal fentanyl patch |
| Bupivacaine | Other | Not described Receives: Other: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first rescue analgesia after surgery (hour)
The time to first rescue analgesia after surgery (hour)
Measured: The first 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start5 Sep 2023
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007378
- Sponsor's protocol ID
- FMASU MS 416 / 2023
- Status last verified
- Feb 2026
- First submitted
- 17 Aug 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery by Supplementing Ultrasound-guided Erector Spinae Plane Block With Ketamine or Transdermal Fentanyl Patch
- ClinicalTrials.gov ID
- NCT06007378
- Acronym / sponsor ID
- FMASU MS 416 / 2023
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine and ketamine | Other | Other: Bupivacaine and ketamine |
| Bupivacaine and transdermal fentanyl patch | Other | Other: Bupivacaine and transdermal fentanyl patch |
| Bupivacaine | Other | Other: Bupivacain |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing laparoscopic colorectal surgery.
- American Society of Anesthesiologists (ASA) physical status I or II.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine and ketamineBilateral erector spinae plane block (bupivacaine and ketamine) | Other | Bupivacaine and ketamine |
| Bupivacaine and transdermal fentanyl patchBilateral erector spinae plane block (bupivacaine) and transdermal fentanyl patch | Other | Bupivacaine and transdermal fentanyl patch |
| BupivacainBilateral erector spinae plane block (bupivacaine) | Other | Bupivacaine |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
Related trials for Postoperative Pain
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and ketamine, Bupivacaine and transdermal fentanyl patch and Bupivacain in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to first rescue analgesia after surgery (hour) (time frame: The first 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.