Laparoscopic CholecystectomyNCT06599255
One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block
A study testing US-guided RSB and TAPB by one-puncture technique. and multipont in people with Laparoscopic Cholecystectomy, run by Zagazig University at 1 site in Egypt.
Trial summary
the purpose of this study is to compare of better postoperative analgesia following laparoscopic cholecystectomy using either one puncture rectus sheath block with transverse abdominis plane block or multipoint technique Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- US-guided RSB and TAPB by one-puncture technique. and multipont
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2024to 10 Dec 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-45 years old.
- Sex: both sexes.
- Physical status: ASA I to III.
- Body mass index (BMI): 18- 30 kg/m2.
- Type of operations: elective laparoscopic cholecystectomy.
- Written informed consent from the patient.
Who cannot join
- Known hypersensitivity to lidocaine or bupivacaine.
- Opioid-dependent patients.
- Coagulation disorders or taking drugs affect surgical hemostasis.
- Patients with pre-existing neurological deficits.
- Uncooperative patient or with altered mental status.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine,Zagazig University
Zagazig, Elsharkia,, Egypt,, 44519
About this study
Official title: One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block for Analgesia After Laparoscopic Cholecystectomy
the purpose of this study is to compare of better postoperative analgesia following laparoscopic cholecystectomy using either one puncture rectus sheath block with transverse abdominis plane block or multipoint technique
Read the detailed description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3 groups each one containing 34In the One puncture \"O\" group (n= 34): The patient will receive one-puncture technique of RSB combined with TAPB.
In the Multipoint \"M \" group (n= 34): The patient will receive multipoint technique of RSB combined with TAPB.
In the Control \"C \" group (n=34 ): The patient will receive patient controlled analgesia\&;PCA\&
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- US-guided RSB and TAPB by one-puncture technique., multipont
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided RSB and TAPB by one-puncture technique.Procedure or surgery
The probe will be positioned transversely in the midline of the abdomen, between the xiphoid process and the umbilicus, revealing the linea alba. It was then moved outward along the costal margin, demonstrating the rectus abdominis overlapping the transverse abdominis. A 22-gauge, 120-mm ultrasound-visible block needle will be inserted from the inner side . Under direct vision, we will reach the posterior rectus abdominis sheath and pierced the anterior layer of the posterior sheath. Saline was injected to adjust its position. After that, 15 mL of 0.25% bupivacaine will be administered (aspiration was performed for every 5 mL injection), and we will observe the local anesthetic spreading inward . Then, the needle will break through the posterior layer of the tendon, and saline will be injected to confirm the needle's placement in the transversus abdominis plane. After confirming the tip placement, 15 mL of 0.25% bupivacaine will be slowly injected. The needle tip will be advanced al
multipontProcedure or surgery
, the probe will be moved outward along the costal margin until the external oblique muscle, internal oblique muscle, and transverse abdominis muscle will be visible [9]. The needle will be inserted in-plane until the tip was positioned in the plane between the internal oblique muscle and the transverse abdominis muscle. Then, 15 mL of 0.25% bupivacaine will be injected . The contralateral nerve block will be performed using the same method and volume of anesthetic solution.
For the RSB, the same technique will be done as one puncture technique. Then, 15 mL of 0.25% bupivacaine will be injected . The contralateral nerve block will be performed using the same method and volume of anesthetic solution.
| Study group | Role | What they receive |
|---|---|---|
| one puncture | Active comparator | one-puncture technique of RSB combined with TAPB. Receives: Procedure: US-guided RSB and TAPB by one-puncture technique. |
| Multipoint | Active comparator | multipoint technique of RSB combined with TAPB. Receives: Procedure: multipont |
| control | No intervention | nalbuphine (2 mg/kg) and normal saline to a total volume of 150 mL, with a background infusion rate of 2 mL/h, a bolus dose of 2 mL, a lockout interval of 15 min, and a maximum limit of 10 mL within 1 h. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total postoperative opioid consumption in the first 24 hours.
opioid consumption
Measured: 24 hours postoperative
Secondary outcomes (4)
The block performance time
the time from the placement of the ultrasound probe on the patient's skin to the end of the local anesthetic injection
Measured: up to 5 minutes
Onset of sensory block
the time from the end of the injection of local anesthetic (bupivacaine) to the loss of pinprick sensation using a sterile 25-G needle in the operation field.
Measured: up to 30 minutes
The Numerical Pain Rating Scale
A ten-centimeter Numerical Pain Rating Scale (0 - no pain and 10 - worst pain)
Measured: 24 hours postoperative
Patient satisfaction
The patient satisfactionwill be assessed using the 7-point Likert-like verbal rating scale The patientwill be asked to express his satisfaction
- extremely dissatisfied.
- Dissatisfied.
- somewhat dissatisfied.
- unsatisfied.
- somewhat satisfied.
- Satisfied.
- extremely satisfied.
Measured: 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Zagazig 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599255
- Sponsor's protocol ID
- ZU-IRB#568/27-AUG-2024
- Status last verified
- Sep 2024
- First submitted
- 30 Aug 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block for Analgesia After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06599255
- Acronym / sponsor ID
- ZU-IRB#568/27-AUG-2024
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 19 Sep 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.
the purpose of this study is to compare of better postoperative analgesia following laparoscopic cholecystectomy using either one puncture rectus sheath block with transverse abdominis plane block or multipoint technique
Detailed description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3 groups each one containing 34In the One puncture \"O\" group (n= 34): The patient will receive one-puncture technique of RSB combined with TAPB.
In the Multipoint \"M \" group (n= 34): The patient will receive multipoint technique of RSB combined with TAPB.
In the Control \"C \" group (n=34 ): The patient will receive patient controlled analgesia\&;PCA\&
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| one puncture | Active comparator | Procedure: US-guided RSB and TAPB by one-puncture technique.one-puncture technique of RSB combined with TAPB. |
| Multipoint | Active comparator | Procedure: multipontmultipoint technique of RSB combined with TAPB. |
| control | No intervention | –nalbuphine (2 mg/kg) and normal saline to a total volume of 150 mL, with a background infusion rate of 2 mL/h, a bolus dose of 2 mL, a lockout interval of 15 min, and a maximum limit of 10 mL within 1 h. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-45 years old.
- Sex: both sexes.
- Physical status: ASA I to III.
- Body mass index (BMI): 18- 30 kg/m2.
- Type of operations: elective laparoscopic cholecystectomy.
Key exclusion criteria (5 listed)
- Known hypersensitivity to lidocaine or bupivacaine.
- Opioid-dependent patients.
- Coagulation disorders or taking drugs affect surgical hemostasis.
- Patients with pre-existing neurological deficits.
- Uncooperative patient or with altered mental status.
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 |
|---|---|---|
| US-guided RSB and TAPB by one-puncture technique.The probe will be positioned transversely in the midline of the abdomen, between the xiphoid process and the umbilicus, revealing the linea alba. It was then moved outward along the costal margin, demonstrating the rectus abdominis overlapping the transverse abdominis. A 22-gauge, 120-mm ultrasound-visible block needle will be inserted from the inner side . Under direct vision, we will reach the posterior rectus abdominis sheath and pierced the anterior layer of the posterior sheath. Saline was injected to adjust its position. After that, 15 mL of 0.25% bupivacaine will be administered (aspiration was performed for every 5 mL injection), and we will observe the local anesthetic spreading inward . Then, the needle will break through the posterior layer of the tendon, and saline will be injected to confirm the needle's placement in the transversus abdominis plane. After confirming the tip placement, 15 mL of 0.25% bupivacaine will be slowly injected. The needle tip will be advanced al | Procedure or surgery | one puncture |
| multipont, the probe will be moved outward along the costal margin until the external oblique muscle, internal oblique muscle, and transverse abdominis muscle will be visible [9]. The needle will be inserted in-plane until the tip was positioned in the plane between the internal oblique muscle and the transverse abdominis muscle. Then, 15 mL of 0.25% bupivacaine will be injected . The contralateral nerve block will be performed using the same method and volume of anesthetic solution. For the RSB, the same technique will be done as one puncture technique. Then, 15 mL of 0.25% bupivacaine will be injected . The contralateral nerve block will be performed using the same method and volume of anesthetic solution. | Procedure or surgery | Multipoint |
Primary outcome
The total postoperative opioid consumption in the first 24 hours.
Time frame: 24 hours postoperative
opioid consumption
4 secondary outcomes
The block performance time
Time frame: up to 5 minutes
Onset of sensory block
Time frame: up to 30 minutes
The Numerical Pain Rating Scale
Time frame: 24 hours postoperative
Patient satisfaction
Time frame: 24 hour postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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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. 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 US-guided RSB and TAPB by one-puncture technique. and multipont in people with Laparoscopic Cholecystectomy, run by Zagazig 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Sep 2024. 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?
Results are not available in the source record.
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 total postoperative opioid consumption in the first 24 hours. (time frame: 24 hours postoperative). 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 20 Sep 2024.