Postoperative PainTAPNCT06156657
Postoperative Analgesia of TAP Block for Laparoscopic Sleeve Gastrectomy
A study testing subcostal TAP block in people with Postoperative Pain, run by Al-Azhar University at 1 site in Egypt.
Trial summary
many methods were considered to control postoperative pain in laparoscopic bariatic surgery including non steroidal anti-inflammatory drugs, opioids and neuraxial block but subcostal (TAP) block has provided good analgesic effect when used as a part of multimodal analgesia in bariatric surgery due to lack of visceral… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- subcostal TAP block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2023to 15 Dec 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-60 years
- ASA Ι-ΙΙ
- BMI >35
Who cannot join
- Patient refusal.
- Allergy to study drugs.
- Infection at site of injection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Azhar University
Cairo, Naser City, 11811
Ahmed M Selim, director, 0020222611404, info@azhar.edu.eg
About this study
Official title: Postoperative Efficacy of Subcostal TAP Block in Laparoscopic Sleeve Gastrectomy Surgery: a Randomized Controlled Trial
many methods were considered to control postoperative pain in laparoscopic bariatic surgery including non steroidal anti-inflammatory drugs, opioids and neuraxial block
but subcostal (TAP) block has provided good analgesic effect when used as a part of multimodal analgesia in bariatric surgery due to lack of visceral block
Read the detailed description
Since long time opioid have been used to control postoperative pain in bariatric surgery However, an increasing awareness of opioid-related adverse events, including respiratory depression, paralytic ileums, and sedation, constipation has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia As neuroaxial block and ultrasound guided nerve blocks
As the transverse abdominis plane (TAP) block which is of increasing interest nowadays (Basaran B, et al 2015)
The ultrasound-guided oblique SCTAP block, first described by Hebbard et al., has the potential to provide analgesia for both upper and lower abdominal surgery. There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions
The TAP block via various approaches provides some advantages over neuraxial anesthesia (Ganapathy Set al 2015). For example, TAP blocks are associated with a lower use of intraoperative phenylephrine and a lesser degree of intraoperative blood pressure changes. The SCTAP block may be utilized in cases in which neuraxial anesthesia is contraindicated, such as patients with coagulation issues or infection at the epidural puncture site. Although the SCTAP block provides sensory blockade of the abdominal wall, it is lacking in coverage of visceral pain (Lissauer J,et al 2014).
The lack of visceral pain analgesia may require the use of additional methods of postoperative pain control such as intravenous opioids or non-narcotic analgesics.
- Conditions
- Postoperative Pain
- Being tested
- subcostal TAP block
- Keywords
- subcostal TAP, laparoscopic, sleeve gastrectomy
- 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 TAP blockOther
Comparison between subcostal TAP block and opioids for postoperative pain after laparscopic sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| TAP group | Active comparator | patients candidate for laparoscopic sleeve gastrectomy to receive GA and subcostal TAP block to control postoperative pain and minimize opioid consumption Receives: Other: subcostal TAP block |
| Control group | No intervention | healthy controls candidate for laparoscopic sleeve gastrectomy to receive GA only opioids were used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain control
by using VAS score
Measured: 9 months
Secondary outcomes (2)
postoperative 24 hour opioid consumption
collecting total doses of opioids consumed in the first 24 hours postoperative in cmparison to the other group
Measured: 9 months
postoperative nausea and vomiting
recording incidence, frequency and severity
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start30 Jan 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Mohamed Abdelgawad Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156657
- Sponsor's protocol ID
- TAP block
- Acronym
- TAP
- Status last verified
- Nov 2023
- First submitted
- 26 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are planned to be coded for privacy protection
Publications
Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.
PubMed 25948166Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.
PubMed 20830871Ganapathy S, Sondekoppam RV, Terlecki M, Brookes J, Das Adhikary S, Subramanian L. Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):797-804. doi: 10.1097/EJA.0000000000000345.
PubMed 26426576Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.
PubMed 24993433
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Efficacy of Subcostal TAP Block in Laparoscopic Sleeve Gastrectomy Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06156657
- Acronym / sponsor ID
- TAP / TAP block
- Conditions
- Postoperative Pain
- Keywords
- subcostal TAP, laparoscopic, sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 5 Dec 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.
many methods were considered to control postoperative pain in laparoscopic bariatic surgery including non steroidal anti-inflammatory drugs, opioids and neuraxial block
but subcostal (TAP) block has provided good analgesic effect when used as a part of multimodal analgesia in bariatric surgery due to lack of visceral block
Detailed description
Since long time opioid have been used to control postoperative pain in bariatric surgery However, an increasing awareness of opioid-related adverse events, including respiratory depression, paralytic ileums, and sedation, constipation has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia As neuroaxial block and ultrasound guided nerve blocks
As the transverse abdominis plane (TAP) block which is of increasing interest nowadays (Basaran B, et al 2015)
The ultrasound-guided oblique SCTAP block, first described by Hebbard et al., has the potential to provide analgesia for both upper and lower abdominal surgery. There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions
The TAP block via various approaches provides some advantages over neuraxial anesthesia (Ganapathy Set al 2015). For example, TAP blocks are associated with a lower use of intraoperative phenylephrine and a lesser degree of intraoperative blood pressure changes. The SCTAP block may be utilized in cases in which neuraxial anesthesia is contraindicated, such as patients with coagulation issues or infection at the epidural puncture site. Although the SCTAP block provides sensory blockade of the abdominal wall, it is lacking in coverage of visceral pain (Lissauer J,et al 2014).
The lack of visceral pain analgesia may require the use of additional methods of postoperative pain control such as intravenous opioids or non-narcotic analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP group | Active comparator | Other: subcostal TAP blockpatients candidate for laparoscopic sleeve gastrectomy to receive GA and subcostal TAP block to control postoperative pain and minimize opioid consumption |
| Control group | No intervention | –healthy controls candidate for laparoscopic sleeve gastrectomy to receive GA only opioids were used |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-60 years
- ASA Ι-ΙΙ
- BMI >35
Key exclusion criteria (3 listed)
- Patient refusal.
- Allergy to study drugs.
- Infection at site of injection.
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 TAP blockComparison between subcostal TAP block and opioids for postoperative pain after laparscopic sleeve gastrectomy | Other | TAP group |
Primary outcome
Postoperative pain control
Time frame: 9 months
by using VAS score
2 secondary outcomes
postoperative 24 hour opioid consumption
Time frame: 9 months
postoperative nausea and vomiting
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 25948166Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.
- Background: PubMed 20830871Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.
- Background: PubMed 26426576Ganapathy S, Sondekoppam RV, Terlecki M, Brookes J, Das Adhikary S, Subramanian L. Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):797-804. doi: 10.1097/EJA.0000000000000345.
- Background: PubMed 24993433Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.
- Individual participant dataSharing planned: No. IPD are planned to be coded for privacy protection
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcostal TAP block in people with Postoperative Pain, run by Al-Azhar 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 3 inclusion and 3 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 5 Dec 2023. 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?
Contact Ismail M Ahmed, prof (00201117310053, ismailabdelgawad.623@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain control (time frame: 9 months). 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 NCT06156657, which also lists 4 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 5 Dec 2023.