Postoperative Pain, AcuteNCT06778668
Effectiveness of Fentanyl-Added TAP Block in Laparoscopic Cholecystectomy
A study testing TAP block with bupivacaine only and TAP block with bupivacaine and fentanyl in people with Postoperative Pain, Acute, run by Uludag University.
Trial summary
The aim of this study is to evaluate the effectiveness of adding fentanyl to the TAP block in laparoscopic cholecystectomy cases. It is hypothesized that the addition of fentanyl to the TAP block will enhance the quality of postoperative analgesia and prolong the duration of blockade compared to the TAP block… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- TAP block with bupivacaine only and TAP block with bupivacaine and fentanyl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years
- American Society of Anesthesiologists (ASA) classification I-II-III according to the American Society of Anesthesiologists
- Patients who provide written informed consent
- Patients scheduled for elective laparoscopic cholecystectomy
Who cannot join
- Pregnancy or suspected pregnancy
- BMI > 35
- Known allergy to local anesthetics or opioids
- Suspected coagulopathy or infection at the injection site
- Severe neurological, psychiatric, cardiovascular, liver, or renal failure
- Patients converted to open surgery intraoperatively
About this study
Official title: Evaluation of the Effectiveness of Adding Fentanyl to Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Cholecystectomy
The aim of this study is to evaluate the effectiveness of adding fentanyl to the TAP block in laparoscopic cholecystectomy cases. It is hypothesized that the addition of fentanyl to the TAP block will enhance the quality of postoperative analgesia and prolong the duration of blockade compared to the TAP block performed with bupivacaine alone. The study aims to determine the most effective approach by comparing these two treatment methods with a control group.
Read the detailed description
Cholecystectomy was first performed in 1882 by Karl Langenbuch and is widely used for the treatment of symptomatic gallbladder diseases, such as acute cholecystitis and cholelithiasis. Today, the laparoscopic technique is preferred due to its advantages, including faster recovery, better cosmetic outcomes, and shorter hospital stays. However, despite these benefits, postoperative pain, particularly in the shoulder and abdomen, remains a common issue after laparoscopic surgery and is one of the primary causes of delayed discharge. This pain can be attributed to incision sites, peritoneal irritation caused by the insufflation gas, and trocar entry points.
Effective management of postoperative pain is crucial for accelerating recovery and preventing the development of chronic pain. One of the key strategies in multimodal analgesia is the Transversus Abdominis Plane (TAP) block, which can reduce both postoperative pain and the need for opioids. First described by Rafi in 2001, TAP block gained widespread use after Hebbart et al. demonstrated in 2007 that it could be applied more effectively and safely under ultrasound guidance. The block involves injecting local anesthetics into the neurofascial plane between the transversus abdominis and internal oblique muscles, where the intercostal, subcostal, ilioinguinal, and iliohypogastric nerves run.
Since the identification of opioid receptors in peripheral nerves, there has been interest in combining opioids with local anesthetics to enhance the duration and quality of peripheral nerve blocks. Studies have shown that certain opioids, including fentanyl and sufentanil, exhibit local anesthetic-like effects. Fentanyl, a commonly used opioid, has been shown to improve analgesia quality and prolong the duration of subarachnoid blocks when combined with local anesthetics.
This study aims to evaluate the effectiveness of adding fentanyl to the TAP block, which is routinely performed in our clinic, in laparoscopic cholecystectomy cases. The hypothesis is that the addition of fentanyl to bupivacaine in the TAP block will improve the quality of postoperative analgesia and prolong the block duration.
A total of 66 patients undergoing laparoscopic cholecystectomy will be included in the study. Patients will be randomized into three groups:
Group 1: TAP block with bupivacaine only, Group 2: TAP block with bupivacaine and fentanyl, Group 3: Control group (no TAP block). All patients will receive standard general anesthesia protocols, and TAP block will be performed before the surgical procedure. Postoperatively, pain scores (VAS), rescue analgesia requirements, additional analgesic and antiemetic use, complications, and patient satisfaction will be evaluated. The study will also assess whether fentanyl prolongs the block duration and improves postoperative analgesia quality.
The goal of this study is to compare these approaches and determine the most effective method for managing postoperative pain in laparoscopic cholecystectomy cases.
- Conditions
- Postoperative Pain, Acute
- Being tested
- TAP block with bupivacaine only, TAP block with bupivacaine and fentanyl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block with bupivacaine onlyProcedure or surgery
Patients undergoing laparoscopic cholecystectomy will receive TAP block with bupivacaine only after induction and before the surgical procedure begins.
TAP block with bupivacaine and fentanylProcedure or surgery
Patients undergoing laparoscopic cholecystectomy will receive a TAP block with bupivacaine and fentanyl after induction and before the surgical procedure begins
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1, a unilateral TAP block will be applied using the linear probe (38 mm, 6 MHz) of the ultrasound device routinely used in our clinic. The procedure will be performed in the supine position under aseptic conditions. The ultrasound probe will be placed horizontally in the right subcostal region (an anatomical area following the lower border of the ribs). A 50 mm block needle will be advanced into the fascial plane between the transversus abdominis and rectus abdominis muscles. A total of 20 ml of 0.25% bupivacaine solution will be administered, with a maximum dose of 2 mg/kg. Receives: Procedure: TAP block with bupivacaine only |
| Group 2 | Active comparator | In Group 2, a unilateral TAP block will be applied using the linear probe (38 mm, 6 MHz) of the ultrasound device in the supine position under aseptic conditions. The ultrasound probe will be placed horizontally in the right subcostal region, and a 50 mm block needle will be advanced into the fascial plane between the transversus abdominis and rectus abdominis muscles. A total of 20 ml of block solution containing 0.25% bupivacaine and 50 mcg fentanyl will be administered. Receives: Procedure: TAP block with bupivacaine and fentanyl |
| Group 3 | No intervention | Patients in Group 3 will serve as the control group, and no block will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analog Scale
The Visual Analog Scale (VAS) is a simple and widely used tool to assess the intensity of pain or symptoms. It helps convert patients' subjective experiences (such as pain, discomfort, or fatigue) into a numerical value. This scale is particularly useful in evaluating postoperative pain and chronic pain conditions.
How Does VAS Work? The VAS typically consists of a 10 cm horizontal or vertical line. One end of the line is labeled "No Pain", and the other end is labeled "Worst Pain Possible".
The patient is asked to mark a point on the line that best represents their pain intensity.
The marked point is measured with a ruler to obtain a score between 0 and 10.
VAS Scoring:
VAS Score Pain Level 0 No pain 1-3 Mild pain 4-6 Moderate pain 7-10 Severe and unbearable pain
Areas of Use:
Postoperative pain assessment Chronic pain management Conditions like migraine, arthritis, or cancer pain Evaluating physical and emotional symptoms (e.g., anxiety or depression)
Measured: 1 day
Secondary outcomes (2)
Rescue Analgesic Requirement
It will be applied to patients with a VAS score above 5.
Measured: 1 day
The 5-point Likert scale
Patient satisfaction will be assessed using a 5-point Likert scale.The 5-point Likert scale is a widely used rating scale to measure attitudes, opinions, and perceptions in surveys and questionnaires. In clinical studies, it is often used to assess patient satisfaction, allowing patients to rate their experiences on a scale from strongly dissatisfied to strongly satisfied.
Structure of the 5-Point Likert Scale:
Score Response
- Strongly Dissatisfied
- Dissatisfied
- Neutral
- Satisfied
- Strongly Satisfied
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start10 Feb 2025 (estimated)
- Primary completion9 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into three groups: Group 1: TAP block with bupivacaine only, Group 2: TAP block with bupivacaine and fentanyl, Group 3: Control group (no TAP block).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Çabuk, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778668
- Sponsor's protocol ID
- UU-AN-MC-01
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Adding Fentanyl to Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06778668
- Acronym / sponsor ID
- UU-AN-MC-01
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 9 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 16 Jan 2025 (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.
The aim of this study is to evaluate the effectiveness of adding fentanyl to the TAP block in laparoscopic cholecystectomy cases. It is hypothesized that the addition of fentanyl to the TAP block will enhance the quality of postoperative analgesia and prolong the duration of blockade compared to the TAP block performed with bupivacaine alone. The study aims to determine the most effective approach by comparing these two treatment methods with a control group.
Detailed description
Cholecystectomy was first performed in 1882 by Karl Langenbuch and is widely used for the treatment of symptomatic gallbladder diseases, such as acute cholecystitis and cholelithiasis. Today, the laparoscopic technique is preferred due to its advantages, including faster recovery, better cosmetic outcomes, and shorter hospital stays. However, despite these benefits, postoperative pain, particularly in the shoulder and abdomen, remains a common issue after laparoscopic surgery and is one of the primary causes of delayed discharge. This pain can be attributed to incision sites, peritoneal irritation caused by the insufflation gas, and trocar entry points.
Effective management of postoperative pain is crucial for accelerating recovery and preventing the development of chronic pain. One of the key strategies in multimodal analgesia is the Transversus Abdominis Plane (TAP) block, which can reduce both postoperative pain and the need for opioids. First described by Rafi in 2001, TAP block gained widespread use after Hebbart et al. demonstrated in 2007 that it could be applied more effectively and safely under ultrasound guidance. The block involves injecting local anesthetics into the neurofascial plane between the transversus abdominis and internal oblique muscles, where the intercostal, subcostal, ilioinguinal, and iliohypogastric nerves run.
Since the identification of opioid receptors in peripheral nerves, there has been interest in combining opioids with local anesthetics to enhance the duration and quality of peripheral nerve blocks. Studies have shown that certain opioids, including fentanyl and sufentanil, exhibit local anesthetic-like effects. Fentanyl, a commonly used opioid, has been shown to improve analgesia quality and prolong the duration of subarachnoid blocks when combined with local anesthetics.
This study aims to evaluate the effectiveness of adding fentanyl to the TAP block, which is routinely performed in our clinic, in laparoscopic cholecystectomy cases. The hypothesis is that the addition of fentanyl to bupivacaine in the TAP block will improve the quality of postoperative analgesia and prolong the block duration.
A total of 66 patients undergoing laparoscopic cholecystectomy will be included in the study. Patients will be randomized into three groups:
Group 1: TAP block with bupivacaine only, Group 2: TAP block with bupivacaine and fentanyl, Group 3: Control group (no TAP block). All patients will receive standard general anesthesia protocols, and TAP block will be performed before the surgical procedure. Postoperatively, pain scores (VAS), rescue analgesia requirements, additional analgesic and antiemetic use, complications, and patient satisfaction will be evaluated. The study will also assess whether fentanyl prolongs the block duration and improves postoperative analgesia quality.
The goal of this study is to compare these approaches and determine the most effective method for managing postoperative pain in laparoscopic cholecystectomy cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized into three groups: Group 1: TAP block with bupivacaine only, Group 2: TAP block with bupivacaine and fentanyl, Group 3: Control group (no TAP block).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: TAP block with bupivacaine onlyGroup 1, a unilateral TAP block will be applied using the linear probe (38 mm, 6 MHz) of the ultrasound device routinely used in our clinic. The procedure will be performed in the supine position under aseptic conditions. The ultrasound probe will be placed horizontally in the right subcostal region (an anatomical area following the lower border of the ribs). A 50 mm block needle will be advanced into the fascial plane between the transversus abdominis and rectus abdominis muscles. A total of 20 ml of 0.25% bupivacaine solution will be administered, with a maximum dose of 2 mg/kg. |
| Group 2 | Active comparator | Procedure: TAP block with bupivacaine and fentanylIn Group 2, a unilateral TAP block will be applied using the linear probe (38 mm, 6 MHz) of the ultrasound device in the supine position under aseptic conditions. The ultrasound probe will be placed horizontally in the right subcostal region, and a 50 mm block needle will be advanced into the fascial plane between the transversus abdominis and rectus abdominis muscles. A total of 20 ml of block solution containing 0.25% bupivacaine and 50 mcg fentanyl will be administered. |
| Group 3 | No intervention | –Patients in Group 3 will serve as the control group, and no block will be applied. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 70 years
- American Society of Anesthesiologists (ASA) classification I-II-III according to the American Society of Anesthesiologists
- Patients who provide written informed consent
- Patients scheduled for elective laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- Pregnancy or suspected pregnancy
- BMI > 35
- Known allergy to local anesthetics or opioids
- Suspected coagulopathy or infection at the injection site
- Severe neurological, psychiatric, cardiovascular, liver, or renal failure
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 |
|---|---|---|
| TAP block with bupivacaine onlyPatients undergoing laparoscopic cholecystectomy will receive TAP block with bupivacaine only after induction and before the surgical procedure begins. | Procedure or surgery | Group 1 |
| TAP block with bupivacaine and fentanylPatients undergoing laparoscopic cholecystectomy will receive a TAP block with bupivacaine and fentanyl after induction and before the surgical procedure begins | Procedure or surgery | Group 2 |
Primary outcome
The Visual Analog Scale
Time frame: 1 day
The Visual Analog Scale (VAS) is a simple and widely used tool to assess the intensity of pain or symptoms. It helps convert patients' subjective experiences (such as pain, discomfort, or fatigue) into a numerical value. This scale is particularly useful in evaluating postoperative pain and chronic pain conditions. How Does VAS Work? The VAS typically consists of a 10 cm horizontal or vertical line. One end of the line is labeled "No Pain", and the other end is labeled "Worst Pain Possible". The patient is asked to mark a point on the line that best represents their pain intensity. The marked point is measured with a ruler to obtain a score between 0 and 10. VAS Scoring: VAS Score Pain Level 0 No pain 1-3 Mild pain 4-6 Moderate pain 7-10 Severe and unbearable pain Areas of Use: Postoperative pain assessment Chronic pain management Conditions like migraine, arthritis, or cancer pain Evaluating physical and emotional symptoms (e.g., anxiety or depression)
2 secondary outcomes
Rescue Analgesic Requirement
Time frame: 1 day
The 5-point Likert scale
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block with bupivacaine only and TAP block with bupivacaine and fentanyl in people with Postoperative Pain, Acute, run by Uludag University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 Visual Analog Scale (time frame: 1 day). 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 16 Jan 2025.