Postoperative PainNCT03516786
Quality of Recovery After Quadratus Lumborum Block for Cesarean Section.
An observational study of Postoperative Pain, run by Corniche Hospital at 1 site in United Arab Emirates.
Trial summary
The aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive Quadratus Lumborum Block (QLB) as a part of multimodal analgesia using Postoperative quality of recovery scale. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain
- How many people
- 25 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Apr 2018to 1 Oct 2019
- Phase
- Observational
- 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 45 years
- Women only
- Adult
Study population: Twenty five parturients, with American Society of Anesthesiologists (ASA) physical status II, with normal singleton pregnancy, at 37 weeks gestation or more, admitted to Corniche Hospital for elective caesarean section under spinal anesthesia
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status II, normal singleton pregnancy, 37 weeks gestation or more Scheduled for elective cesarean section
Who cannot join
- Patients refusing spinal
- Patients with BMI >35 kg/m2).
- Expected difficult surgery (> 3 previous sections, abnormal placentation, prolonged surgery more than 2 hours from skin to end) and Estimated Blood Loss more than 1500).
- Expected difficult spinal anesthesia.
- Abnormal coagulation and other contraindications for spinal anesthesia and/or QLB
- Patient with chronic pain.
- Patient treated from psychosis.
- Patients with communication, language barriers .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Recovery After Quadratus Lumborum Block for Cesarean Section: A Prospective Pilot Study
The aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive Quadratus Lumborum Block (QLB) as a part of multimodal analgesia using Postoperative quality of recovery scale.
Read the detailed description
Several researchers had evaluated the effectiveness of QLB in controlling postoperative pain in different patient populations. In these studies, the effectiveness of the QLB was mainly assessed by postoperative pain scores and analgesia consumption, rather than adapting any of the more comprehensive recovery scales .
Postoperative quality of recovery scale (PostopQRS) is a relatively new recovery score, which was first published on 2010, and was designed to be a tool for assessment of multiple domains in recovery. In this assessment tool, recovery was defined as return to the pre-surgery base line scores or better.
The aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive Quadratus Lumborum Block QLB as a part of multimodal analgesia using Postoperative quality of recovery scale.
- Conditions
- Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline postoperative quality of recovery score
Domains of postoperative recovery score are :
- The physiologic domain .
- The nociceptive domain
- The emotive domain .
- Activities of daily living
- Cognitive domain
- Over all patients perspective domain
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Apr 2018
- Primary completion15 Sep 2019
- Study completion1 Oct 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corniche Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waleed Riad, MD, Principal investigator, Corniche HospitalAmr Maher, MD, Principal investigator, Corncihe hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516786
- Sponsor's protocol ID
- Ch1712171
- Status last verified
- Sep 2020
- First submitted
- 19 Mar 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery After Quadratus Lumborum Block for Cesarean Section: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT03516786
- Acronym / sponsor ID
- Ch1712171
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Corniche HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 4 May 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 aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive Quadratus Lumborum Block (QLB) as a part of multimodal analgesia using Postoperative quality of recovery scale.
Detailed description
Several researchers had evaluated the effectiveness of QLB in controlling postoperative pain in different patient populations. In these studies, the effectiveness of the QLB was mainly assessed by postoperative pain scores and analgesia consumption, rather than adapting any of the more comprehensive recovery scales .
Postoperative quality of recovery scale (PostopQRS) is a relatively new recovery score, which was first published on 2010, and was designed to be a tool for assessment of multiple domains in recovery. In this assessment tool, recovery was defined as return to the pre-surgery base line scores or better.
The aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive Quadratus Lumborum Block QLB as a part of multimodal analgesia using Postoperative quality of recovery scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Twenty five parturients, with American Society of Anesthesiologists (ASA) physical status II, with normal singleton pregnancy, at 37 weeks gestation or more, admitted to Corniche Hospital for elective caesarean section under spinal anesthesia
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status II, normal singleton pregnancy, 37 weeks gestation or more Scheduled for elective cesarean section
Key exclusion criteria (8 listed)
- Patients refusing spinal
- Patients with BMI >35 kg/m2).
- Expected difficult surgery (> 3 previous sections, abnormal placentation, prolonged surgery more than 2 hours from skin to end) and Estimated Blood Loss more than 1500).
- Expected difficult spinal anesthesia.
- Abnormal coagulation and other contraindications for spinal anesthesia and/or QLB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change from baseline postoperative quality of recovery score
Time frame: 72 hours
Domains of postoperative recovery score are : 1. The physiologic domain . 2. The nociceptive domain 3. The emotive domain . 4. Activities of daily living 5. Cognitive domain 6. Over all patients perspective domain
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 16 Sep 2020.
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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.
Waleed Riad, MD principal investigator
Corniche Hospital
Amr Maher, MD principal investigator
Corncihe hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Corniche Hospital at 1 site in United Arab Emirates.
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: finished, as of the sponsor's last update on 16 Sep 2020. 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 United Arab Emirates. 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?
change from baseline postoperative quality of recovery score (time frame: 72 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 16 Sep 2020.