The Quality of Recovery (ObsQOR-11)
Conditions
Brief 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.
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.
Interventions
DRUGDexmedetomidine
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Participants will be full-term pregnant females * ASA classification I or ll. * Aged between 18 and 40 years. * Singleton pregnancy
Exclusion criteria
* 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..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery score following CS (ObsQor-11) at the end of the first 24 hours postoperative. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications of spinal anaesthesia and TAP block | 12 hours post operative period. | Complications of spinal anaesthesia and TAP block |
| Incidence of hypotension | post spinal anesthesia up to 1 hour | systolic blood pressure \< 90 or \<70% of baseline |
| Incidence of bradycardia | post spinal anesthesia up to 1 hour | heart rate less than 60 beats per minute |
| Time of first request of analgesia in hours | within 24 hours postoperative | from time of spinal anesthesia to the first registration of VAS score more than 3 |
| Ramsay sedation scale | 1, 2, 4, 6, 8, 12 and 24 hours | 1. Awake; agitated or restless or both 2. Awake; cooperative, oriented, and tranquil 3. Awake but responds to commands only 4. Asleep; brisk response to light glabellar tap or loud auditory stimulus 5. Asleep; sluggish response to light glabellar tap or loud auditory stimulus 6. Asleep; no response to glabellar tap or loud auditory stimulus |
| Intra operative non-invasive mean blood pressure | within 24 hours postoperative | in mmhg |
| Intra operative heart rate | within 24 hours postoperative | beats per minutes |
| Visual Analogue Scale | 1, 2, 4, 6, 8, 12 and 24 hours postoperative | 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') |
| Nausea and vomiting | intraoperative and postoperative 24 hours | Nausea and vomiting |
| Onset of motor block using Bromage scale | Post spinal anesthesia up to 30 minutes | 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). |
| Onset of sensory block | Post spinal anesthesia up to 30 minutes | 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. |
| Neonatal Apgar score | at 1 and 5 minutes post delivery | 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. |
Countries
Egypt
Outcome results
None listed