Postoperative PainNCT05244746
Efficacy of Ultrasound Guided Rectus Sheath Block on Post Operative Quality of Recovery
A study testing rectus sheath block in people with Postoperative Pain, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Effective Postoperative pain management following laparotomy represents a cornerstone in the care of surgical patients. With the growing utilization of Enhanced recovery after surgery protocols (ERAS), a paradigm shift in perioperative care has resulted in reduction of both hospital stay and clinical complications… 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?
- rectus sheath block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Jun 2022
- 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
- 18-60 years old patients
- ASA 1-2 patients
- Patients undergoing elective midline laparotomy.
Who cannot join
- 1. refusal to consent, 2. previous laparotomy (subsequently amended to exclude only a laparotomy with a paramedian scar), 3. significant hepatic or renal disease, 4. any condition limiting the use of co-analgesics (diclofenac and acetaminophen), 5. coagulopathy (international normalized ratio: 1.5 ) 6. Patients with body weight \ 50 kg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound Guided Rectus Sheath Block Combined With General Anaesthesia on the Postoperative Quality of Recovery Profile in Laparotomy Surgeries, Randomized Control Trial.
Effective Postoperative pain management following laparotomy represents a cornerstone in the care of surgical patients. With the growing utilization of Enhanced recovery after surgery protocols (ERAS), a paradigm shift in perioperative care has resulted in reduction of both hospital stay and clinical complications faced by patients.
One important component of successful implementation of ERAS protocol is optimized pain control. It has been shown that opioids have a considerable role in reducing bowel motility in addition; it hinders early mobilization and enteral feeding besides their commonly faced side effects such as nausea and vomiting.
Read more
Consequently, ERAS programs encourage the usage of multimodal opioid sparing analgesia which includes neuraxial or regional anesthesia techniques to provide effective pain relief while reducing the opioid related side effects. [1]
Regional blocks have remained popular with evidence of superior postoperative pain control when compared with systemic analgesics. Regional anaesthesia techniques have undergone considerable refinement with the advent of ultrasound guidance. Ultrasound visualization of anatomical structures increases both the safety and quality of regional blocks through optimal needle placement. Ultrasound-guided rectus sheath (RS) blocks are an emerging anaesthetic technique providing excellent analgesia after laparotomy. The anatomic characteristics of this block suggest minimal serious complications are likely, and this regional block is particularly useful where epidural is contraindicated
- Conditions
- Postoperative Pain
- Being tested
- 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.
rectus sheath blockProcedure or surgery
blocking the nerve underneath the rectus muscle by bupivicaine
| Study group | Role | What they receive |
|---|---|---|
| Rectus sheath block | Active comparator | Not described Receives: Procedure: rectus sheath block |
| Control | Placebo comparator | Not described Receives: Procedure: rectus sheath block |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery
using QOR-15 questionnaire
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 posted17 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abougabal, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244746
- Sponsor's protocol ID
- MS-202-2021
- Status last verified
- Aug 2022
- First submitted
- 11 Feb 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Guided Rectus Sheath Block Combined With General Anaesthesia on the Postoperative Quality of Recovery Profile in Laparotomy Surgeries, Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05244746
- Acronym / sponsor ID
- MS-202-2021
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 17 Feb 2022 (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.
Effective Postoperative pain management following laparotomy represents a cornerstone in the care of surgical patients. With the growing utilization of Enhanced recovery after surgery protocols (ERAS), a paradigm shift in perioperative care has resulted in reduction of both hospital stay and clinical complications faced by patients.
One important component of successful implementation of ERAS protocol is optimized pain control. It has been shown that opioids have a considerable role in reducing bowel motility in addition; it hinders early mobilization and enteral feeding besides their commonly faced side effects such as nausea and vomiting.
Consequently, ERAS programs encourage the usage of multimodal opioid sparing analgesia which includes neuraxial or regional anesthesia techniques to provide effective pain relief while reducing the opioid related side effects. [1]
Regional blocks have remained popular with evidence of superior postoperative pain control when compared with systemic analgesics. Regional anaesthesia techniques have undergone considerable refinement with the advent of ultrasound guidance. Ultrasound visualization of anatomical structures increases both the safety and quality of regional blocks through optimal needle placement. Ultrasound-guided rectus sheath (RS) blocks are an emerging anaesthetic technique providing excellent analgesia after laparotomy. The anatomic characteristics of this block suggest minimal serious complications are likely, and this regional block is particularly useful where epidural is contraindicated
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus sheath block | Active comparator | Procedure: rectus sheath block |
| Control | Placebo comparator | Procedure: 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)
- 18-60 years old patients
- ASA 1-2 patients
- Patients undergoing elective midline laparotomy.
Key exclusion criteria (1 listed)
- 1. refusal to consent, 2. previous laparotomy (subsequently amended to exclude only a laparotomy with a paramedian scar), 3. significant hepatic or renal disease, 4. any condition limiting the use of co-analgesics (diclofenac and acetaminophen), 5. coagulopathy (international normalized ratio: 1.5 ) 6. Patients with body weight \ 50 kg.
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 |
|---|---|---|
| rectus sheath blockblocking the nerve underneath the rectus muscle by bupivicaine | Procedure or surgery | Control, Rectus sheath block |
Primary outcome
quality of recovery
Time frame: 24 hours
using QOR-15 questionnaire
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 15 Aug 2022.
- Individual participant dataSharing planned: Yes
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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 rectus sheath block in people with Postoperative Pain, run by Kasr El Aini Hospital 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 1 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 15 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
quality of recovery (time frame: 24 hours). 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 15 Aug 2022.