Perioperative Analgesia in Major Upper Abdominal SurgeryPhase 3NCT05691933
Regional Block for Upper Abdominal Surgeries
A Phase 3 study testing Block group and Morphine infusion in people with Perioperative Analgesia in Major Upper Abdominal Surgery, run by Alexandria University.
Trial summary
Pain control after major upper abdominal surgeries is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks. Regional blocks allow better pain control and avoid side effects of opioid based pain control Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Analgesia in Major Upper Abdominal Surgery
- What is being tested?
- Block group and Morphine infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Jul 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing upper abdominal surgeries
Who cannot join
- BMI above 40
- allergy for drugs used
- complicated cases
- patient refusal
- chronic opioid use
- cognitive dysfunction
- chronic kidney disease
- Liver failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided External Oblique Intercostal Plane Block for Perioperative Analgesia in Major Upper Abdominal Surgery: Prospective Randomized Controlled Study
Pain control after major upper abdominal surgeries is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.
Regional blocks allow better pain control and avoid side effects of opioid based pain control
Read the detailed description
Ultrasound guided External oblique intercostal plane block for perioperative analgesia in major upper abdominal surgery: Prospective randomized controlled study
Introduction:
Pain control is a vital component to achieve enhanced recovery after major upper abdominal surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.
Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Epidural analgesia, another routinely used analgesic technique, offers equivalent or superior pain scores when compared to conventional systemic opioids. Enhanced recovery following major upper abdominal surgery has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.
The external oblique intercostal plane block is a new modality that will be used to improve pain-related outcomes after major upper abdominal surgeries, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane block can reduce cumulative opioid consumption for the patients undergoing major upper abdominal surgery when added to conventional multi-model intravenous analgesic technique.
The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane block in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing major upper abdominal surgery.
Patients and Methods:
A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 20-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane block and group II (60) will be subjected to morphine infusion at a rate of 0.03mg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.
- Being tested
- Block group, Morphine infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block groupProcedure or surgery
Patient will be subjected to bilateral external oblique intercostal plane block
Morphine infusionProcedure or surgery
Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Block group | Active comparator | Patients will be subjected to bilateral external oblique intercostal plane block Receives: Procedure: Block group |
| Opioid group | Active comparator | Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h Receives: Procedure: Morphine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine requirements for 24 hours
Visual analogue score will be measured every 2 hours
Measured: 24 hours postoperatively
Secondary outcomes (3)
Pain assessment
Visual analogue score will be assessed every 2hours postoperatively
Measured: 24 hours postoperatively
Rescue analgesia
0.5 microgram/kg fentanyl will be given if VAS score more than 4
Measured: 24 hours postoperatively
Side effects
Any side effect related to fentanyl or block
Measured: 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 posted20 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (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 Perioperative Analgesia in Major Upper Abdominal SurgeryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691933
- Sponsor's protocol ID
- 0305400
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on request
Publications
Hughes M, McNally S, McKeown DW, Wigmore S. Effect of analgesic modality on outcome following open liver surgery: a systematic review of postoperative analgesia. Minerva Anestesiol. 2015 May;81(5):541-56. Epub 2014 Jun 11.
PubMed 24918191Rosero EB, Cheng GS, Khatri KP, Joshi GP. Evaluation of epidural analgesia for open major liver resection surgery from a US inpatient sample. Proc (Bayl Univ Med Cent). 2014 Oct;27(4):305-12. doi: 10.1080/08998280.2014.11929141.
PubMed 25484494
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided External Oblique Intercostal Plane Block for Perioperative Analgesia in Major Upper Abdominal Surgery: Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05691933
- Acronym / sponsor ID
- 0305400
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 20 Jan 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.
Pain control after major upper abdominal surgeries is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.
Regional blocks allow better pain control and avoid side effects of opioid based pain control
Detailed description
Ultrasound guided External oblique intercostal plane block for perioperative analgesia in major upper abdominal surgery: Prospective randomized controlled study
Introduction:
Pain control is a vital component to achieve enhanced recovery after major upper abdominal surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.
Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Epidural analgesia, another routinely used analgesic technique, offers equivalent or superior pain scores when compared to conventional systemic opioids. Enhanced recovery following major upper abdominal surgery has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.
The external oblique intercostal plane block is a new modality that will be used to improve pain-related outcomes after major upper abdominal surgeries, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane block can reduce cumulative opioid consumption for the patients undergoing major upper abdominal surgery when added to conventional multi-model intravenous analgesic technique.
The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane block in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing major upper abdominal surgery.
Patients and Methods:
A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 20-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane block and group II (60) will be subjected to morphine infusion at a rate of 0.03mg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block group | Active comparator | Procedure: Block groupPatients will be subjected to bilateral external oblique intercostal plane block |
| Opioid group | Active comparator | Procedure: Morphine infusionPatients will be subjected to morphine infusion at a rate of 0.03mg/kg/h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing upper abdominal surgeries
Key exclusion criteria (8 listed)
- BMI above 40
- Liver failure
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 |
|---|---|---|
| Block groupPatient will be subjected to bilateral external oblique intercostal plane block | Procedure or surgery | Block group |
| Morphine infusionPatients will be subjected to morphine infusion at a rate of 0.03mg/kg/h | Procedure or surgery | Opioid group |
Primary outcome
Postoperative morphine requirements for 24 hours
Time frame: 24 hours postoperatively
Visual analogue score will be measured every 2 hours
3 secondary outcomes
Pain assessment
Time frame: 24 hours postoperatively
Rescue analgesia
Time frame: 24 hours postoperatively
Side effects
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 24918191Hughes M, McNally S, McKeown DW, Wigmore S. Effect of analgesic modality on outcome following open liver surgery: a systematic review of postoperative analgesia. Minerva Anestesiol. 2015 May;81(5):541-56. Epub 2014 Jun 11.
- Background: PubMed 25484494Rosero EB, Cheng GS, Khatri KP, Joshi GP. Evaluation of epidural analgesia for open major liver resection surgery from a US inpatient sample. Proc (Bayl Univ Med Cent). 2014 Oct;27(4):305-12. doi: 10.1080/08998280.2014.11929141.
- Individual participant dataSharing planned: Yes. Data will be shared on request
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Block group and Morphine infusion in people with Perioperative Analgesia in Major Upper Abdominal Surgery, run by Alexandria 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 1 inclusion and 8 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 25 Jan 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohamed Abdelmawla, MD (+201114748411, M_abdelmawla12@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine requirements for 24 hours (time frame: 24 hours postoperatively). 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 NCT05691933, 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 25 Jan 2023.