Laparoscopic CholecystectomyPhase 4NCT06722963
Comparison of the Efficacy of Intraperitoneal Instillation of Fentanyl Versus Nalbuphine as Adjuvants to Bupivacaine for Postoperative Pain Relief in Patients Undergoing Laparoscopic Cholecystectomy
A Phase 4 study testing fentanyl and Nalbuphine in people with Laparoscopic Cholecystectomy, run by Assiut University.
Trial summary
Given the complexity of postoperative pain following laparoscopic surgery, specialists recommend a multimodal approach to effective analgesic management . The origin of pain after LC is multifactorial and complex in nature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- fentanyl and Nalbuphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Feb 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Both sex
- Patients who were in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)
Who cannot join
- • Patient's refusal.
- body mass index (BMI) ≥40 kg/m2.
- History of hypersensitivity to the drugs being evaluated
- Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
- chronic use of opioids and opioid addiction
- Patients with acute cholecystitis
Show all 9Show fewer
- Carcinoma of gall bladder
- Pregnant female
- Bleeding disorders
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Given the complexity of postoperative pain following laparoscopic surgery, specialists recommend a multimodal approach to effective analgesic management . The origin of pain after LC is multifactorial and complex in nature. Pain arising from incision sites is parietal pain, whereas pain from the gall bladder bed is mainly visceral in nature, and shoulder pain is mainly referred owing to the residual CO2 irritating the diaphragm. Various strategies have been employed for pain relief after laparoscopic procedures, including the use of intraperitoneal local anesthetics, either alone or in combination with opioid analgesics.
the efficacy of intraperitoneal instillation of fentanyl versus nalbuphine as adjuvants to Bupivacaine for postoperative pain relief in patients undergoing laparoscopic cholecystectomy
Read the detailed description
Laparoscopic cholecystectomy (LC) is recognized as the gold standard for managing gallbladder stones due to its numerous advantages over open surgery . These benefits include quicker and easier recovery, reduced operative morbidity, less postoperative pain, shorter convalescence, and overall lower costs
Intraperitoneal administration of local anesthetics is used by many surgeons as a method to provide effective pain relief while minimizing the adverse effects of systemic analgesics, including NSAIDs and opioids. The rationale for this route of administration is that the local anesthetics will block the visceral nociceptive conduction from peritoneum. In addition, systemic absorption from the large peritoneal surface may occur, providing additional mechanism of analgesia . This technique was first evaluated in patients undergoing gynecological laparoscopy and showed reduction in postoperative shoulder pain . With the possibility that a similar analgesic effect might be achieved in LC, several trials assessing the efficacy of Intraperitoneal local anesthetics in LC were carried out with conflicting results, regarding severity of postoperative pain, duration of analgesia, and total analgesic consumption in 24 h. The difference in outcome of studies on instillation of local anesthetics may result from dose, volume, or concentration of the drug; timing of instillation (before or after surgery); site of administration (subdiaphragmatic, over gall bladder bed, and/or port infiltration); and instillation in Trendelenberg's versus supine position .
Fentanyl and nalbuphine are two widely used opioids considered for pain management . Fentanyl is a potent synthetic opioid similar to morphine but produces analgesia to a greater extent. This robust pharmacologic agent is typically 50 to 100 times more potent than morphine . it is renowned for its rapid onset and strong analgesic properties. It is extensively used in clinical settings to manage acute pain .
On the other hand, nalbuphine, a mixed agonist-antagonist opioid, acts as an antagonist at μ-receptors and agonist at k-receptors that work reasonably potent analgesia. It offers effective pain relief, particularly with a lower risk of respiratory depression. It also provides prolonged analgesia and is associated with fewer side effects, such as pruritus, nausea, and vomiting, than fentanyl .
This route of administration is noninvasive, simple to perform, does not involve additional neuraxial block, and is particularly suited for the practice of ambulatory anesthesia. However, duration of analgesia may be limited for few hours. So, addition of adjuvants such as narcotics, α2 agonists, or NSAIDs has been proposed to prolong the postoperative analgesia
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- fentanyl, Nalbuphine
- Keywords
- fentanyl, nalbuphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
Fentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose is 50 micrograms is commonly added to the local anesthetic solution.
NalbuphineDrug
Nalbuphine in doses ranging from 10 mg have been studied as adjuvants to bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl group | Experimental | Fentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose is 50 micrograms is commonly added to the local anesthetic solution. Receives: Drug: fentanyl |
| Nalbuphine group | Experimental | patients will receive Nalbuphine in a Doses ranging from 10 mg have been studied as adjuvants to bupivacaine Receives: Drug: Nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first analgesic request
comparison of the post-operative analgesic effect regarding the time to first analgesic request of fentanyl versus nalbuphine as adjuvants to Bupivacaine in patients undergoing laparoscopic cholecystectomy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Saad Reyad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722963
- Sponsor's protocol ID
- fentanyl vs nalbuphine cholecy
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Laisalmi M, Koivusalo AM, Valta P, Tikkanen I, Lindgren L. Clonidine provides opioid-sparing effect, stable hemodynamics, and renal integrity during laparoscopic cholecystectomy. Surg Endosc. 2001 Nov;15(11):1331-5. doi: 10.1007/s004640090126. Epub 2001 Aug 16.
PubMed 11727145Khodorova A, Navarro B, Jouaville LS, Murphy JE, Rice FL, Mazurkiewicz JE, Long-Woodward D, Stoffel M, Strichartz GR, Yukhananov R, Davar G. Endothelin-B receptor activation triggers an endogenous analgesic cascade at sites of peripheral injury. Nat Med. 2003 Aug;9(8):1055-61. doi: 10.1038/nm885. Epub 2003 Jun 29.
PubMed 12847519Kuhry E, Jeekel J, Bonjer HJ. Effect of laparoscopy on the immune system. Semin Laparosc Surg. 2004 Mar;11(1):37-44. doi: 10.1177/107155170401100107.
PubMed 15094977
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Intraperitoneal Instillation of Fentanyl Versus Nalbuphine as Adjuvants to Bupivacaine for Postoperative Pain Relief in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06722963
- Acronym / sponsor ID
- fentanyl vs nalbuphine cholecy
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- fentanyl, nalbuphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
Given the complexity of postoperative pain following laparoscopic surgery, specialists recommend a multimodal approach to effective analgesic management . The origin of pain after LC is multifactorial and complex in nature. Pain arising from incision sites is parietal pain, whereas pain from the gall bladder bed is mainly visceral in nature, and shoulder pain is mainly referred owing to the residual CO2 irritating the diaphragm. Various strategies have been employed for pain relief after laparoscopic procedures, including the use of intraperitoneal local anesthetics, either alone or in combination with opioid analgesics.
the efficacy of intraperitoneal instillation of fentanyl versus nalbuphine as adjuvants to Bupivacaine for postoperative pain relief in patients undergoing laparoscopic cholecystectomy
Detailed description
Laparoscopic cholecystectomy (LC) is recognized as the gold standard for managing gallbladder stones due to its numerous advantages over open surgery . These benefits include quicker and easier recovery, reduced operative morbidity, less postoperative pain, shorter convalescence, and overall lower costs
Intraperitoneal administration of local anesthetics is used by many surgeons as a method to provide effective pain relief while minimizing the adverse effects of systemic analgesics, including NSAIDs and opioids. The rationale for this route of administration is that the local anesthetics will block the visceral nociceptive conduction from peritoneum. In addition, systemic absorption from the large peritoneal surface may occur, providing additional mechanism of analgesia . This technique was first evaluated in patients undergoing gynecological laparoscopy and showed reduction in postoperative shoulder pain . With the possibility that a similar analgesic effect might be achieved in LC, several trials assessing the efficacy of Intraperitoneal local anesthetics in LC were carried out with conflicting results, regarding severity of postoperative pain, duration of analgesia, and total analgesic consumption in 24 h. The difference in outcome of studies on instillation of local anesthetics may result from dose, volume, or concentration of the drug; timing of instillation (before or after surgery); site of administration (subdiaphragmatic, over gall bladder bed, and/or port infiltration); and instillation in Trendelenberg's versus supine position .
Fentanyl and nalbuphine are two widely used opioids considered for pain management . Fentanyl is a potent synthetic opioid similar to morphine but produces analgesia to a greater extent. This robust pharmacologic agent is typically 50 to 100 times more potent than morphine . it is renowned for its rapid onset and strong analgesic properties. It is extensively used in clinical settings to manage acute pain .
On the other hand, nalbuphine, a mixed agonist-antagonist opioid, acts as an antagonist at μ-receptors and agonist at k-receptors that work reasonably potent analgesia. It offers effective pain relief, particularly with a lower risk of respiratory depression. It also provides prolonged analgesia and is associated with fewer side effects, such as pruritus, nausea, and vomiting, than fentanyl .
This route of administration is noninvasive, simple to perform, does not involve additional neuraxial block, and is particularly suited for the practice of ambulatory anesthesia. However, duration of analgesia may be limited for few hours. So, addition of adjuvants such as narcotics, α2 agonists, or NSAIDs has been proposed to prolong the postoperative analgesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl group | Experimental | Drug: fentanylFentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose is 50 micrograms is commonly added to the local anesthetic solution. |
| Nalbuphine group | Experimental | Drug: Nalbuphinepatients will receive Nalbuphine in a Doses ranging from 10 mg have been studied as adjuvants to bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Both sex
- Patients who were in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)
Key exclusion criteria (9 listed)
- • Patient's refusal.
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 |
|---|---|---|
| fentanylFentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose is 50 micrograms is commonly added to the local anesthetic solution. | Drug | Fentanyl group |
| NalbuphineNalbuphine in doses ranging from 10 mg have been studied as adjuvants to bupivacaine | Drug | Nalbuphine group |
Primary outcome
time to first analgesic request
Time frame: 24 hours
comparison of the post-operative analgesic effect regarding the time to first analgesic request of fentanyl versus nalbuphine as adjuvants to Bupivacaine in patients undergoing laparoscopic cholecystectomy
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 9 Dec 2024.
- Results publication: PubMed 11727145Laisalmi M, Koivusalo AM, Valta P, Tikkanen I, Lindgren L. Clonidine provides opioid-sparing effect, stable hemodynamics, and renal integrity during laparoscopic cholecystectomy. Surg Endosc. 2001 Nov;15(11):1331-5. doi: 10.1007/s004640090126. Epub 2001 Aug 16.
- Results publication: PubMed 12847519Khodorova A, Navarro B, Jouaville LS, Murphy JE, Rice FL, Mazurkiewicz JE, Long-Woodward D, Stoffel M, Strichartz GR, Yukhananov R, Davar G. Endothelin-B receptor activation triggers an endogenous analgesic cascade at sites of peripheral injury. Nat Med. 2003 Aug;9(8):1055-61. doi: 10.1038/nm885. Epub 2003 Jun 29.
- Results publication: PubMed 15094977Kuhry E, Jeekel J, Bonjer HJ. Effect of laparoscopy on the immune system. Semin Laparosc Surg. 2004 Mar;11(1):37-44. doi: 10.1177/107155170401100107.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fentanyl and Nalbuphine in people with Laparoscopic Cholecystectomy, run by Assiut 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 3 inclusion and 9 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 9 Dec 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact SAMEH SAAD REYAD, resident doctor (+201271499376, samah123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first analgesic request (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06722963, which also lists 3 linked publications.
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 9 Dec 2024.