The Quality of Recovery (ObsQOR-11)Phase 4NCT05991466
Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections
A Phase 4 study testing Dexmedetomidine in people with The Quality of Recovery (ObsQOR-11), run by Cairo University at 1 site in Egypt.
Trial summary
The study hypothesizes that addition of dexmedetomidine to bupivacaine either in spinal anesthesia or TAP block is more effective and provide better ObsQor-11score than bupivacaine alone. Also, Dexmedetomidine in TAP block might provide a longer pain free time in comparison to intrathecal dexmedetomidine. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- The Quality of Recovery (ObsQOR-11)
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Phase 4
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be full-term pregnant females
- ASA classification I or ll.
- Aged between 18 and 40 years.
- Singleton pregnancy
Who cannot join
- Refusal of block.
- Bleeding disorders (platelets count <150,000; INR>1.5; PC<60%).
- wounds or infection at the puncture site.
- Known allergy to local anesthetic drugs.
- Contraindications to neuroaxial block.
- Contraindications to TAP block..
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate, 11562
About this study
Official title: The Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections: a Randomized Comparative Study
The study hypothesizes that addition of dexmedetomidine to bupivacaine either in spinal anesthesia or TAP block is more effective and provide better ObsQor-11score than bupivacaine alone. Also, Dexmedetomidine in TAP block might provide a longer pain free time in comparison to intrathecal dexmedetomidine.
Read the detailed description
Aim of the work To compare the quality of recovery (ObsQOR-11) in patients undergoing cesarean sections receiving dexmedetomedine either intrathecally or in the tap block in comparison to patients receiving conventional spinal anesthesia and tap block.
Statistical Analysis I. Sample size In a pilot study on 5 parturient who had undergone elective cesarean section under spinal anesthesia followed by TAP block with bupivacaine alone, the mean ObsQoR-11 at 24 hours was 65±9. In a single factor ANOVA study, sample size of 126 from the 3 groups is needed to detect a difference of at least 10 using the Tukey-Kramer (Pairwise) multiple comparison with study power of 83% and alpha error of 0.05. The common standard deviation within a group is assumed to be 9. The number of envelopes will be increased to 141 (47 per group) to compensate of possible 10% dropout. The sample size was calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
II. Statistical analysis Data will be coded and entered using the statistical package SPSS (statistical package for the social science) version 22. Data will be summarized using mean, standard deviation, median, minimum and maximum in quantitative data and using frequency (count) and relative frequency(percentage)for categorical data. Comparisons between quantitative variables will be done using the non parametric Mann-Whitney test. For comparing categorical data, Chi square (x2 ) test will be performed. Exact test will be used instead when the expected frequency is less than 5. P-value less than 0.05 will be considered as statistically significant.
- Conditions
- The Quality of Recovery (ObsQOR-11)
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications. The required laboratory work will be: complete blood count (CBC); prothrombin time and concentration (PT\&PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT); liver function tests and kidney function tests.
Before arrival to the operation room (OR), women will be premedicated by metoclopramide 10mg and ranitidine 50 mg intravenous. Intra operatively, hemodynamics will be recorded baseline before spinal anaesthesia , after its performance, every 3 minutes until delivery and then every 10 minutes till the end of the CS. Any change within 20% of baseline will be accepted and any changes more than 20% will be managed according to guidelines. All groups will be anaesthetized to preform CS with conventional spinal anaesthesia. The TAP block group will receive a landmark orientated Ultrasound guided bilateral TAP block.
| Study group | Role | What they receive |
|---|---|---|
| Group(A) | Active comparator | Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg and TAP block will be performed with 30 ml 0.25% bupivacaine in each side. Receives: Drug: Dexmedetomidine |
| Group (B) | Active comparator | Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine10-12 mg and TAP block will be performed with 50 mcg Dexmedetomidine added to 30ml 0.25% bupivacaine in each side. Receives: Drug: Dexmedetomidine |
| Group (C) | Active comparator | Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg added to 5 mcg dexmedetomidine. TAP block will be performed with 30ml 0.25% bupivacaine in each side. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery score following CS (ObsQor-11) at the end of the first 24 hours postoperative.
The mothers will be asked to rate each recovery item with an 11-point numerical Likert scale (0 = strongly negative; 10 = strongly positive).
Measured: 24 hours postoperative
Secondary outcomes (12)
Time of first request of analgesia in hours
from time of spinal anesthesia to the first registration of VAS score more than 3
Measured: within 24 hours postoperative
Ramsay sedation scale
- Awake; agitated or restless or both
- Awake; cooperative, oriented, and tranquil
- Awake but responds to commands only
- Asleep; brisk response to light glabellar tap or loud auditory stimulus
- Asleep; sluggish response to light glabellar tap or loud auditory stimulus
- Asleep; no response to glabellar tap or loud auditory stimulus
Measured: 1, 2, 4, 6, 8, 12 and 24 hours
Intra operative non-invasive mean blood pressure
in mmhg
Measured: within 24 hours postoperative
Intra operative heart rate
beats per minutes
Measured: within 24 hours postoperative
Visual Analogue Scale
VAS score at rest and during movement and cough The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: 1, 2, 4, 6, 8, 12 and 24 hours postoperative
Nausea and vomiting
Nausea and vomiting
Measured: intraoperative and postoperative 24 hours
Onset of motor block using Bromage scale
defined as the time from giving spinal anesthesia until a modified Bromage score of IV will be reached),Duration of motor block (defined as the time from spinal anesthesia until Modified Bromage score of I).
Measured: Post spinal anesthesia up to 30 minutes
Onset of sensory block
defined as the time needed to lose cold sensation when using the ice-cold test at the T6 dermatome level) and time to 2-segment regression of spinal anesthesia.
Measured: Post spinal anesthesia up to 30 minutes
Neonatal Apgar score
This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2.
Measured: at 1 and 5 minutes post delivery
Complications of spinal anaesthesia and TAP block
Complications of spinal anaesthesia and TAP block
Measured: 12 hours post operative period.
Incidence of hypotension
systolic blood pressure < 90 or <70% of baseline
Measured: post spinal anesthesia up to 1 hour
Incidence of bradycardia
heart rate less than 60 beats per minute
Measured: post spinal anesthesia up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2022
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Quality of Recovery (ObsQOR-11)Studies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Youssef Ollaek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991466
- Sponsor's protocol ID
- MD-172-2021
- Status last verified
- Nov 2024
- First submitted
- 26 Jun 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections: a Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05991466
- Acronym / sponsor ID
- MD-172-2021
- Conditions
- The Quality of Recovery (ObsQOR-11)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Aug 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.
The study hypothesizes that addition of dexmedetomidine to bupivacaine either in spinal anesthesia or TAP block is more effective and provide better ObsQor-11score than bupivacaine alone. Also, Dexmedetomidine in TAP block might provide a longer pain free time in comparison to intrathecal dexmedetomidine.
Detailed description
Aim of the work To compare the quality of recovery (ObsQOR-11) in patients undergoing cesarean sections receiving dexmedetomedine either intrathecally or in the tap block in comparison to patients receiving conventional spinal anesthesia and tap block.
Statistical Analysis I. Sample size In a pilot study on 5 parturient who had undergone elective cesarean section under spinal anesthesia followed by TAP block with bupivacaine alone, the mean ObsQoR-11 at 24 hours was 65±9. In a single factor ANOVA study, sample size of 126 from the 3 groups is needed to detect a difference of at least 10 using the Tukey-Kramer (Pairwise) multiple comparison with study power of 83% and alpha error of 0.05. The common standard deviation within a group is assumed to be 9. The number of envelopes will be increased to 141 (47 per group) to compensate of possible 10% dropout. The sample size was calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
II. Statistical analysis Data will be coded and entered using the statistical package SPSS (statistical package for the social science) version 22. Data will be summarized using mean, standard deviation, median, minimum and maximum in quantitative data and using frequency (count) and relative frequency(percentage)for categorical data. Comparisons between quantitative variables will be done using the non parametric Mann-Whitney test. For comparing categorical data, Chi square (x2 ) test will be performed. Exact test will be used instead when the expected frequency is less than 5. P-value less than 0.05 will be considered as statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group(A) | Active comparator | Drug: DexmedetomidineSpinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg and TAP block will be performed with 30 ml 0.25% bupivacaine in each side. |
| Group (B) | Active comparator | Drug: DexmedetomidineSpinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine10-12 mg and TAP block will be performed with 50 mcg Dexmedetomidine added to 30ml 0.25% bupivacaine in each side. |
| Group (C) | Active comparator | Drug: DexmedetomidineSpinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg added to 5 mcg dexmedetomidine. TAP block will be performed with 30ml 0.25% bupivacaine in each side. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants will be full-term pregnant females
- ASA classification I or ll.
- Aged between 18 and 40 years.
- Singleton pregnancy
Key exclusion criteria (6 listed)
- Refusal of block.
- Bleeding disorders (platelets count <150,000; INR>1.5; PC<60%).
- wounds or infection at the puncture site.
- Known allergy to local anesthetic drugs.
- Contraindications to neuroaxial block.
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 |
|---|---|---|
| DexmedetomidineAll patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications. The required laboratory work will be: complete blood count (CBC); prothrombin time and concentration (PT\&PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT); liver function tests and kidney function tests. Before arrival to the operation room (OR), women will be premedicated by metoclopramide 10mg and ranitidine 50 mg intravenous. Intra operatively, hemodynamics will be recorded baseline before spinal anaesthesia , after its performance, every 3 minutes until delivery and then every 10 minutes till the end of the CS. Any change within 20% of baseline will be accepted and any changes more than 20% will be managed according to guidelines. All groups will be anaesthetized to preform CS with conventional spinal anaesthesia. The TAP block group will receive a landmark orientated Ultrasound guided bilateral TAP block. | Drug | Group (B), Group (C), Group(A) |
Primary outcome
Quality of recovery score following CS (ObsQor-11) at the end of the first 24 hours postoperative.
Time frame: 24 hours postoperative
The mothers will be asked to rate each recovery item with an 11-point numerical Likert scale (0 = strongly negative; 10 = strongly positive).
12 secondary outcomes
Time of first request of analgesia in hours
Time frame: within 24 hours postoperative
Ramsay sedation scale
Time frame: 1, 2, 4, 6, 8, 12 and 24 hours
Intra operative non-invasive mean blood pressure
Time frame: within 24 hours postoperative
Intra operative heart rate
Time frame: within 24 hours postoperative
Visual Analogue Scale
Time frame: 1, 2, 4, 6, 8, 12 and 24 hours postoperative
Nausea and vomiting
Time frame: intraoperative and postoperative 24 hours
Onset of motor block using Bromage scale
Time frame: Post spinal anesthesia up to 30 minutes
Onset of sensory block
Time frame: Post spinal anesthesia up to 30 minutes
Neonatal Apgar score
Time frame: at 1 and 5 minutes post delivery
Complications of spinal anaesthesia and TAP block
Time frame: 12 hours post operative period.
Incidence of hypotension
Time frame: post spinal anesthesia up to 1 hour
Incidence of bradycardia
Time frame: post spinal anesthesia up to 1 hour
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 5 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for The Quality of Recovery (ObsQOR-11)
RecruitingObservational study
The Impact of Fasting Duration on Quality of Recovery After Cesarean Section
Quality Improvement, Quality of Recovery From Anaesthesia
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 Phase 4 study testing Dexmedetomidine in people with The Quality of Recovery (ObsQOR-11), run by Cairo 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 4 inclusion and 6 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 5 Dec 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 score following CS (ObsQor-11) at the end of the first 24 hours postoperative. (time frame: 24 hours postoperative). 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 5 Dec 2025.