Postoperative PainNCT03732027
Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients
A study testing Surgical Transversus Abdominis Plane Block and Surgical Rectus Sheath Block in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare between two surgical techniques for anterior abdominal wall blocks in obese patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane [TAP] block versus Rectus Sheath block as regards the efficacy and adverse effects Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Surgical Transversus Abdominis Plane Block and Surgical Rectus Sheath Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Oct 2018to 23 Jan 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- female patients
- undergoing major gynecological surgery with supraumbilical midline incision the first time
- Body mass index (BMI) more than 40.
Who cannot join
- patient refusal to participate in the study,
- reoperation,
- addiction
- alcohol abuse
- hypersensitivity or allergy to the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane Block Versus Surgical Rectus Sheath Block
The purpose of this study is to compare between two surgical techniques for anterior abdominal wall blocks in obese patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane [TAP] block versus Rectus Sheath block as regards the efficacy and adverse effects
- Conditions
- Postoperative Pain
- Being tested
- Surgical Transversus Abdominis Plane Block, Surgical Rectus Sheath Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Transversus Abdominis Plane BlockProcedure or surgery
At the end of operation and after hemostasis, 20 ml of 0.25% bupivacaine will be injected intra-abdominally into the Transversus Abdominis plane at the midpoint of the line connecting the crista iliaca and inferior costal margin and at two locations in the lateral abdominal wall at 3-4 cm inferior to the previous midline injection. The same procedure will be repeated on the opposite side using an identical amount of local anesthetic.
Surgical Rectus Sheath BlockProcedure or surgery
At the end of operation and after hemostasis,20 ml 0.25% bupivacaine will be administered slowly under direct vision after careful aspiration to the rectus sheath space which is present inbetween rectus abdominis muscle and the posterior layer of its sheath at the upper pole of the midline incision by time of closure of the anterior abdominal wall. The procedure will be repeated on the opposite side.
| Study group | Role | What they receive |
|---|---|---|
| Transversus Abdominis Block [TB] group | Active comparator | Patients will receive Surgical Transversus Abdominis Plane Block Receives: Procedure: Surgical Transversus Abdominis Plane Block |
| Rectus Sheath Block [RB] group | Active comparator | Patients will receive Surgical Rectus Sheath Block Receives: Procedure: Surgical Rectus Sheath Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of morphine consumption
Measured: First 24 hours postoperatively
Secondary outcomes (2)
Numerical rate scale
Postoperative pain will be assessed at rest and coughing using numerical rate scale (NRS) patients are asked to rate their pain on a scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible,".
Measured: First 24 hours postoperatively
Postoperative respiratory functions
will be measured using incentive spirometer. Patients were asked to do sustained maximal inspiration (SMI) three times. Then average SMI will be recorded. They will be instructed prior to induction of general anesthesia about the usage of incentive spirometer then a basal measurement will be obtained. After recovery, measurement will be obtained on 60 min, 6 hours, 12 hrs and 24 hrs.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start23 Oct 2018
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Khairy Elbeialy, Ain Shams University
- Investigators
- Marwa AK Elbeialy, MD, Principal investigator, Faculty of Medicine,Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732027
- Sponsor's protocol ID
- FMASU R55 /2018
- Status last verified
- Aug 2021
- First submitted
- 3 Nov 2018
- Last updated
- 23 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane Block Versus Surgical Rectus Sheath Block
- ClinicalTrials.gov ID
- NCT03732027
- Acronym / sponsor ID
- FMASU R55 /2018
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 6 Nov 2018 (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 between two surgical techniques for anterior abdominal wall blocks in obese patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane [TAP] block versus Rectus Sheath block as regards the efficacy and adverse effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus Abdominis Block [TB] group | Active comparator | Procedure: Surgical Transversus Abdominis Plane BlockPatients will receive Surgical Transversus Abdominis Plane Block |
| Rectus Sheath Block [RB] group | Active comparator | Procedure: Surgical Rectus Sheath BlockPatients will receive Surgical Rectus Sheath Block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female patients
- undergoing major gynecological surgery with supraumbilical midline incision the first time
- Body mass index (BMI) more than 40.
Key exclusion criteria (5 listed)
- patient refusal to participate in the study,
- reoperation,
- addiction
- alcohol abuse
- hypersensitivity or allergy to the study drugs
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 |
|---|---|---|
| Surgical Transversus Abdominis Plane BlockAt the end of operation and after hemostasis, 20 ml of 0.25% bupivacaine will be injected intra-abdominally into the Transversus Abdominis plane at the midpoint of the line connecting the crista iliaca and inferior costal margin and at two locations in the lateral abdominal wall at 3-4 cm inferior to the previous midline injection. The same procedure will be repeated on the opposite side using an identical amount of local anesthetic. | Procedure or surgery | Transversus Abdominis Block [TB] group |
| Surgical Rectus Sheath BlockAt the end of operation and after hemostasis,20 ml 0.25% bupivacaine will be administered slowly under direct vision after careful aspiration to the rectus sheath space which is present inbetween rectus abdominis muscle and the posterior layer of its sheath at the upper pole of the midline incision by time of closure of the anterior abdominal wall. The procedure will be repeated on the opposite side. | Procedure or surgery | Rectus Sheath Block [RB] group |
Primary outcome
Total dose of morphine consumption
Time frame: First 24 hours postoperatively
2 secondary outcomes
Numerical rate scale
Time frame: First 24 hours postoperatively
Postoperative respiratory functions
Time frame: First 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- 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. This study is not recruiting at the moment.
Marwa AK Elbeialy, MD principal investigator
Faculty of Medicine,Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Transversus Abdominis Plane Block and Surgical Rectus Sheath Block in people with Postoperative Pain, run by Ain Shams 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 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: finished, as of the sponsor's last update on 23 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total dose of morphine consumption (time frame: First 24 hours postoperatively). 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 23 Aug 2021.