Post Operative Pain, AcuteNCT06410911
Subcostal Transversus Abdominis Block Versus Erector Spinae Block in Open Cholecystectomy
A study testing Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery., Erector Spinae Block in patients undergoing open cholecystectomy and Sbcostal transversus Abdominis block and erector spinae block for both groups in people with Post Operative Pain, Acute, run by Sohag University.
Trial summary
Open cholecystectomy is a surgical procedure involving the removal of the gallbladder through a traditional, open abdominal incision the surgeon makes an incision in the upper abdomen, exposes the gallbladder, and carefully disconnects and removes it. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery., Erector Spinae Block in patients undergoing open cholecystectomy and Sbcostal transversus Abdominis block and erector spinae block for both groups
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Both sex.
- American Society of Anesthesiologists (ASA) I-II Undergoing elective open cholecystectomy surgery.
- Patients who need at least 24hrs hospital admission.
Who cannot join
- Known allergy to local anesthetics
- Coagulopathy or bleeding disorders
- Severe respiratory disease
- Neurological disorders
- Pregnancy
Trial locations and contacts
No sites are listed yet.
Abdelrahman H Abdelrahman, Prof contact
About this study
Official title: Analgesic Effect of Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Block in Patients Undergoing Open Cholecystectomy Surgery
Open cholecystectomy is a surgical procedure involving the removal of the gallbladder through a traditional, open abdominal incision the surgeon makes an incision in the upper abdomen, exposes the gallbladder, and carefully disconnects and removes it. Postoperative pain management is a critical aspect of patient care following cholecytectomy surgery. Inadequate pain control can lead to a cascade of complications, including atelectasis, pneumonia, and delayed mobilization. These complications can prolong hospital stays, increase healthcare costs, and lead to patient dissatisfaction. Regional anesthesia techniques, such as subcostal transversus abdominis plane (TAP) block abd erector spinae block are commonly used to provide effective analgesia after cholecystectomy surgery. These techniques target the nerves that supply the surgical site, providing pain relief without the need for opioids. Opioids are associated with a number of side effects, including nausea, vomiting, constipation, and respiratory depression. Subcostal TAP block is a relatively new technique that has been shown to be effective in providing postoperative analgesia after upper abdominal surgery. This technique involves injecting local anesthetic into the TAP, a fascial plane that lies between the internal oblique and transversus abdominis muscles. The TAP block provides anesthesia to the nerves that supply the abdominal wall, including the subcostal nerves. Erector Spinae Plane Block is a newer technique targeting the dorsal rami of the T7-T12 spinal nerves, potentially offering broader analgesia encompassing the abdominal wall, thorax, and diaphragm. Early studies suggest improved pain control and respiratory function compared to traditional methods.
- Conditions
- Post Operative Pain, Acute
- Being tested
- Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery., Erector Spinae Block in patients undergoing open cholecystectomy, Sbcostal transversus Abdominis block and erector spinae block for both groups
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery.Procedure or surgery
Subcostal Transversus Abdominis Plain block will be performed under ultrasound guidance using a 5-10 MHz linear transducer. The needle will be inserted perpendicular to the skin 2 fingers below the costal
margin, just lateral to the rectus abdominis muscle. After confirming the needle tip's location within the TAP, 20 mL of 0.25% bupivacaine will be injected on both sides in patients undergoing open cholicystectomy surgery.
Erector Spinae Block in patients undergoing open cholecystectomyProcedure or surgery
Ultrasound-guided Erector Spinae block using 20 mL of 0.25% bupivacaine will be injected bilaterally at the T7- T8 vertebral level in patients undergoing open cholecystectomy The probe will be advanced 3 cm to the right lateral direction and rotated 90 degrees, and the transverse processes will be determined . Next, 5 mL of 2% lidocaine will be administered to the predicted needle entry point. A 22-gauge, peripheral nerve block needle will cephalocaudally advanced by the in-plane technique. The needle tip will be continuously advanced toward the transverse process to 1-2 mm before contact with the transverse process. After negative aspiration, 20 ml of 0.25% bupivacaine will be injected with intermittent negative aspirations into the fascia of the erector spinae muscle.
Sbcostal transversus Abdominis block and erector spinae block for both groupsDrug
Each patients group will recieve a type of block by injecting 20 ml of 0.25% bupivacaine on each side in patients undergoing open cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | subcostal transversus abdominis plane block will be performed 50 patients undergoing open cholecystectomy surgery Receives: Procedure: Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery.; Drug: Sbcostal transversus Abdominis block and erector spinae block for both groups |
| Group B | Active comparator | Ultrasound-guided Erector spinae block will be performed 50 patients undergoing open cholecystectomy surgery Receives: Procedure: Erector Spinae Block in patients undergoing open cholecystectomy; Drug: Sbcostal transversus Abdominis block and erector spinae block for both groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare analgesic effect of both groups post open cholecystectomy surgery
to Compare the analgesic efficacy of subcostal transversus abdominis plain block and Erector Spinae block using Visual Analoug Score in both rest and coughing
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdellatif Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410911
- Sponsor's protocol ID
- Soh-Med-24-04-01MD
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dai L, Ling X, Qian Y. Effect of Ultrasound-Guided Transversus Abdominis Plane Block Combined with Patient-Controlled Intravenous Analgesia on Postoperative Analgesia After Laparoscopic Cholecystectomy: a Double-Blind, Randomized Controlled Trial. J Gastrointest Surg. 2022 Dec;26(12):2542-2550. doi: 10.1007/s11605-022-05450-6. Epub 2022 Sep 13.
PubMed 36100826Viderman D, Aubakirova M, Abdildin YG. Erector Spinae Plane Block in Abdominal Surgery: A Meta-Analysis. Front Med (Lausanne). 2022 Feb 23;9:812531. doi: 10.3389/fmed.2022.812531. eCollection 2022.
PubMed 35280917
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Block in Patients Undergoing Open Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT06410911
- Acronym / sponsor ID
- Soh-Med-24-04-01MD
- Conditions
- Post Operative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 13 May 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.
Open cholecystectomy is a surgical procedure involving the removal of the gallbladder through a traditional, open abdominal incision the surgeon makes an incision in the upper abdomen, exposes the gallbladder, and carefully disconnects and removes it. Postoperative pain management is a critical aspect of patient care following cholecytectomy surgery. Inadequate pain control can lead to a cascade of complications, including atelectasis, pneumonia, and delayed mobilization. These complications can prolong hospital stays, increase healthcare costs, and lead to patient dissatisfaction. Regional anesthesia techniques, such as subcostal transversus abdominis plane (TAP) block abd erector spinae block are commonly used to provide effective analgesia after cholecystectomy surgery. These techniques target the nerves that supply the surgical site, providing pain relief without the need for opioids. Opioids are associated with a number of side effects, including nausea, vomiting, constipation, and respiratory depression. Subcostal TAP block is a relatively new technique that has been shown to be effective in providing postoperative analgesia after upper abdominal surgery. This technique involves injecting local anesthetic into the TAP, a fascial plane that lies between the internal oblique and transversus abdominis muscles. The TAP block provides anesthesia to the nerves that supply the abdominal wall, including the subcostal nerves. Erector Spinae Plane Block is a newer technique targeting the dorsal rami of the T7-T12 spinal nerves, potentially offering broader analgesia encompassing the abdominal wall, thorax, and diaphragm. Early studies suggest improved pain control and respiratory function compared to traditional methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery., Drug: Sbcostal transversus Abdominis block and erector spinae block for both groupssubcostal transversus abdominis plane block will be performed 50 patients undergoing open cholecystectomy surgery |
| Group B | Active comparator | Procedure: Erector Spinae Block in patients undergoing open cholecystectomy, Drug: Sbcostal transversus Abdominis block and erector spinae block for both groupsUltrasound-guided Erector spinae block will be performed 50 patients undergoing open cholecystectomy surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- Both sex.
- American Society of Anesthesiologists (ASA) I-II Undergoing elective open cholecystectomy surgery.
- Patients who need at least 24hrs hospital admission.
Key exclusion criteria (5 listed)
- Known allergy to local anesthetics
- Coagulopathy or bleeding disorders
- Severe respiratory disease
- Neurological disorders
- Pregnancy
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 |
|---|---|---|
| Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery.Subcostal Transversus Abdominis Plain block will be performed under ultrasound guidance using a 5-10 MHz linear transducer. The needle will be inserted perpendicular to the skin 2 fingers below the costal margin, just lateral to the rectus abdominis muscle. After confirming the needle tip's location within the TAP, 20 mL of 0.25% bupivacaine will be injected on both sides in patients undergoing open cholicystectomy surgery. | Procedure or surgery | Group A |
| Erector Spinae Block in patients undergoing open cholecystectomyUltrasound-guided Erector Spinae block using 20 mL of 0.25% bupivacaine will be injected bilaterally at the T7- T8 vertebral level in patients undergoing open cholecystectomy The probe will be advanced 3 cm to the right lateral direction and rotated 90 degrees, and the transverse processes will be determined . Next, 5 mL of 2% lidocaine will be administered to the predicted needle entry point. A 22-gauge, peripheral nerve block needle will cephalocaudally advanced by the in-plane technique. The needle tip will be continuously advanced toward the transverse process to 1-2 mm before contact with the transverse process. After negative aspiration, 20 ml of 0.25% bupivacaine will be injected with intermittent negative aspirations into the fascia of the erector spinae muscle. | Procedure or surgery | Group B |
| Sbcostal transversus Abdominis block and erector spinae block for both groupsEach patients group will recieve a type of block by injecting 20 ml of 0.25% bupivacaine on each side in patients undergoing open cholecystectomy | Drug | Group A, Group B |
Primary outcome
Compare analgesic effect of both groups post open cholecystectomy surgery
Time frame: 24 hours post operative
to Compare the analgesic efficacy of subcostal transversus abdominis plain block and Erector Spinae block using Visual Analoug Score in both rest and coughing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 36100826Dai L, Ling X, Qian Y. Effect of Ultrasound-Guided Transversus Abdominis Plane Block Combined with Patient-Controlled Intravenous Analgesia on Postoperative Analgesia After Laparoscopic Cholecystectomy: a Double-Blind, Randomized Controlled Trial. J Gastrointest Surg. 2022 Dec;26(12):2542-2550. doi: 10.1007/s11605-022-05450-6. Epub 2022 Sep 13.
- Background: PubMed 35280917Viderman D, Aubakirova M, Abdildin YG. Erector Spinae Plane Block in Abdominal Surgery: A Meta-Analysis. Front Med (Lausanne). 2022 Feb 23;9:812531. doi: 10.3389/fmed.2022.812531. eCollection 2022.
- 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.
Abdelrahman H Abdelrahman, Prof contact
Questions about this trial
What is this clinical trial studying?
A study testing Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery., Erector Spinae Block in patients undergoing open cholecystectomy and Sbcostal transversus Abdominis block and erector spinae block for both groups in people with Post Operative Pain, Acute, run by Sohag 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 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 13 May 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.
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?
Contact Mahmoud A Mohamed, Ass lecturer (201117521006, dr.mahmoud.abdellatif91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare analgesic effect of both groups post open cholecystectomy surgery (time frame: 24 hours post operative). 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 NCT06410911, which also lists 2 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 13 May 2024.