Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550414
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Dexmedetomidine As An Adjuvant To Bupivacaine 01 in Labor Analgesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect Of Use of Dexmedetomidine as an Adjuvant to Bupivacaine 01 in Labor Analgesia
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Females who have experienced normal labor for child birth have claimed it to be most difficult and distressing moments of their life due to excruciating and unbearable pain Provision of effective and satisfactory labor analgesia to the parturient helps in achieving greater degree of well-being for both mother and child Several medical and non-medical pain relief methods are used since ages for pain relief during childbirth
Epidural anesthesia and intravenous opioids pethidine are most commonly offered to the mothers for relieving labor pain So far Epidural is considered gold standard in attaining maternal satisfaction for pain free deliveries lt can be modified for individual parturient in order to achieve highest level of comfort and pain relief To attain better and prolonged analgesia several additives have been used with local anesthetists and their effects are studied Epidural opioids are conventionally being used as adjuvants however associated side effects nausea vomiting and pruritus may limit their use An alpha 2 adrenoceptor agonist dexmedetomidine has been effectively used and studied in labor epidurals and provided better analgesia without significant side effects Hamed Lateef Hospital is one of the largest tertiary care private setup offering painless deliveries in Lahore
It is need of the hour to modify and improve our clinical practice in order to achieve highest level of patient satisfaction and provision of best possible maternal and fetal outcome This study is proposed to investigate and elaborate the effect of adding dexmedetomidine to bupivacaine in labor epidurals and to study possible side-effects associated with its use
Epidural anesthesia and intravenous opioids pethidine are most commonly offered to the mothers for relieving labor pain So far Epidural is considered gold standard in attaining maternal satisfaction for pain free deliveries lt can be modified for individual parturient in order to achieve highest level of comfort and pain relief To attain better and prolonged analgesia several additives have been used with local anesthetists and their effects are studied Epidural opioids are conventionally being used as adjuvants however associated side effects nausea vomiting and pruritus may limit their use An alpha 2 adrenoceptor agonist dexmedetomidine has been effectively used and studied in labor epidurals and provided better analgesia without significant side effects Hamed Lateef Hospital is one of the largest tertiary care private setup offering painless deliveries in Lahore
It is need of the hour to modify and improve our clinical practice in order to achieve highest level of patient satisfaction and provision of best possible maternal and fetal outcome This study is proposed to investigate and elaborate the effect of adding dexmedetomidine to bupivacaine in labor epidurals and to study possible side-effects associated with its use
Detailed Description:
Objectives of this study are to evaluate the efficacy of adding dexmedetomidine in labor epidurals with 01 bupivacaine in females undergoing normal vaginal delivery
OPERATIONAT DEFINITIONS
1 Onset of Analgesia
Time required to attain a VAS of less than or equal to 3 after giving loading dose
2 Duration of Analgesia Time after loading dose till the VAS 3 or break-through pain reported by the mother
3 Side effects
Hypotension systolic blood pressure 100 mmHg or a decrease in mean arterial pressure MAP 30 compared to the baseline
Bradycardia heart rate less than 60
Nausea vomiting
Sedation
HYPOTHESIS
Duration of Analgesia is prolonged and onset of analgesia is shortened after adding dexmedetomidine with bupivacaine without any significant side effects
STUDY DESIGN
Prospective double blinded randomized control trial
SETTING
This prospective randomized control trial will be conducted at the Department of anesthesiology Hamed Latif Hospital in six months after approval from local ethical committee
SAMPLE SIZE
Sample size is calculated using G power software Keeping Alpha error 005 and power of study 80 the total sample size is calculated to be 134 It is equally divided in 2 groups This study is proposed for the pregnant females in active labor in obstetrical and gynecological department of Hamed Latin Hospital who request epidural analgesia for pain relief during normal vaginal delivery
SAMPLING TECHNIQUE
Non probability purposive sampling
Sample selection
INFORMED CONSENT
Before participating in the study all cases will be informed about the benefits and risks of epidural analgesia along with the medications used A written informed consent will be obtained after that
MATERIALS AND METHODS
DATA COILECTION PROCEDURE
The closed envelope opened after randomization with the computer-generated method will be used to randomly divide the patient in each group
The included 134 women will be equally allocated into two groups
Control group 64 women which will receive bupivacaine 01 10 ml in normal saline and dexmedetomidine group 64 women that will receive the same amount of bupivacaine in addition to dexmedetomidine 50 microm in normal saline as a loading dose 5 ml incrementss min This will be followed by continuous infusion of bupivacaine 01 at 10 mlh rate for both groups which will be stopped with full cervical dilatation The epidural solutions will be prepared by an anesthesiologist not included in the study Moreover all of the following will be blinded A Anesthesiologist giving epidural analgesia B Resident following labor progress and pain scoring All of the included women in an active second stage of labor with cervical dilatation of 3-5 cm will be give Hartmans solution 500 ml as a preload then routine baseline monitoring will be started including blood pressure non-invasive electrocardiography and pulse oximetry Also they will be explained how to report their pain degree according to the visual analog scale VAS 0 for no pain felt at all to 10 for the worst pain ever felt After that they will be placed in the sitting position with proper sterilization of the back followed by local infiltration of the skin with underlying subcutaneous tissue overlying lumbar L 3-4 and L 4-5 intervertebral disc by lidocaine 2The epidural space will be reached via an 18- gauge needle and this will be ensured using the loss of resistance to air technique Next aspiration will be done to exclude the presence of blood or cerebrospinal fluid followed by injection of 3 ml of lidocaine 2 as a test dose After that a 2O-gauge multi-orifice epidural catheter will be introduced and fixed at 45-55 depth Catheter will be secured and woman will be placed in lateral position to avoid compression of the inferior cavil vein by the pregnant uterus Injection of the study solution will be given only in between uterine contractions to decrease the risk of drug overspread in the epidural space lf VAS3 or break-through pain will be reported by the patient then a top-up dose of bupivacaine 01 10 mlwill be given The top up doses number will be recorded The modified Bromage scale will be used to assess the degree of motor block before installation of the epidural catheter every 15 min during the 1st hour after installation and then every 30 min till delivery
lf Bromage score 2 will be detected bupivacaine infusion rate will be decreased till achieving a score less than 3
1 Side effects will be reported and managed according Both heart rate and arterial blood pressure will be monitored and recorded before the installation of the epidural catheter and 5 15 3045 and 60 min following its installation and then hourly till the end of delivery Hypotension defined as systolic blood pressure 100 mmHg or a decrease in mean arterial pressure MAP 30 compared to the baseline and will be managed by Phenylephrine bolus of 50 micrograms along with intravenous fluids Bradycardia defined as heart rate HR less than 60 beatsm and will be managed by intravenous 05 mg atropine Cardiotocography will be used for fetal heart rate monitoring lf any abnormalities will be detected the mother will be asked to change her position to the left lateral one The time needed for cervical dilatation the duration of each stage of labor and the mode of delivery will recorded After 6 h of delivery mother satisfaction will be assessed with the five-point Likerts scale as follows 1 for poor 2 for fair3 for good 4 for very good and 5 for excellent satisfaction The primary outcome will be the onset of analgesia while the secondary outcomes include the duration of analgesia hemodynamic changes labor progress and maternal complications Data will be entered tabulated and analyzed using SPSS version 26 After data entering baseline characteristics will be described as frequencies and percentages mean values and standard deviation SD or median and range For comparison of two independent groups of qualitative data Chi-Square test or Fishers exact test will be applied Besides Mann-Whitney U test and independent-samples test will be used to compare two groups of non-parametric and parametric quantitative data respectively P values 005 will be considered statistically significant for all of the used statistical tests
OPERATIONAT DEFINITIONS
1 Onset of Analgesia
Time required to attain a VAS of less than or equal to 3 after giving loading dose
2 Duration of Analgesia Time after loading dose till the VAS 3 or break-through pain reported by the mother
3 Side effects
Hypotension systolic blood pressure 100 mmHg or a decrease in mean arterial pressure MAP 30 compared to the baseline
Bradycardia heart rate less than 60
Nausea vomiting
Sedation
HYPOTHESIS
Duration of Analgesia is prolonged and onset of analgesia is shortened after adding dexmedetomidine with bupivacaine without any significant side effects
STUDY DESIGN
Prospective double blinded randomized control trial
SETTING
This prospective randomized control trial will be conducted at the Department of anesthesiology Hamed Latif Hospital in six months after approval from local ethical committee
SAMPLE SIZE
Sample size is calculated using G power software Keeping Alpha error 005 and power of study 80 the total sample size is calculated to be 134 It is equally divided in 2 groups This study is proposed for the pregnant females in active labor in obstetrical and gynecological department of Hamed Latin Hospital who request epidural analgesia for pain relief during normal vaginal delivery
SAMPLING TECHNIQUE
Non probability purposive sampling
Sample selection
INFORMED CONSENT
Before participating in the study all cases will be informed about the benefits and risks of epidural analgesia along with the medications used A written informed consent will be obtained after that
MATERIALS AND METHODS
DATA COILECTION PROCEDURE
The closed envelope opened after randomization with the computer-generated method will be used to randomly divide the patient in each group
The included 134 women will be equally allocated into two groups
Control group 64 women which will receive bupivacaine 01 10 ml in normal saline and dexmedetomidine group 64 women that will receive the same amount of bupivacaine in addition to dexmedetomidine 50 microm in normal saline as a loading dose 5 ml incrementss min This will be followed by continuous infusion of bupivacaine 01 at 10 mlh rate for both groups which will be stopped with full cervical dilatation The epidural solutions will be prepared by an anesthesiologist not included in the study Moreover all of the following will be blinded A Anesthesiologist giving epidural analgesia B Resident following labor progress and pain scoring All of the included women in an active second stage of labor with cervical dilatation of 3-5 cm will be give Hartmans solution 500 ml as a preload then routine baseline monitoring will be started including blood pressure non-invasive electrocardiography and pulse oximetry Also they will be explained how to report their pain degree according to the visual analog scale VAS 0 for no pain felt at all to 10 for the worst pain ever felt After that they will be placed in the sitting position with proper sterilization of the back followed by local infiltration of the skin with underlying subcutaneous tissue overlying lumbar L 3-4 and L 4-5 intervertebral disc by lidocaine 2The epidural space will be reached via an 18- gauge needle and this will be ensured using the loss of resistance to air technique Next aspiration will be done to exclude the presence of blood or cerebrospinal fluid followed by injection of 3 ml of lidocaine 2 as a test dose After that a 2O-gauge multi-orifice epidural catheter will be introduced and fixed at 45-55 depth Catheter will be secured and woman will be placed in lateral position to avoid compression of the inferior cavil vein by the pregnant uterus Injection of the study solution will be given only in between uterine contractions to decrease the risk of drug overspread in the epidural space lf VAS3 or break-through pain will be reported by the patient then a top-up dose of bupivacaine 01 10 mlwill be given The top up doses number will be recorded The modified Bromage scale will be used to assess the degree of motor block before installation of the epidural catheter every 15 min during the 1st hour after installation and then every 30 min till delivery
lf Bromage score 2 will be detected bupivacaine infusion rate will be decreased till achieving a score less than 3
1 Side effects will be reported and managed according Both heart rate and arterial blood pressure will be monitored and recorded before the installation of the epidural catheter and 5 15 3045 and 60 min following its installation and then hourly till the end of delivery Hypotension defined as systolic blood pressure 100 mmHg or a decrease in mean arterial pressure MAP 30 compared to the baseline and will be managed by Phenylephrine bolus of 50 micrograms along with intravenous fluids Bradycardia defined as heart rate HR less than 60 beatsm and will be managed by intravenous 05 mg atropine Cardiotocography will be used for fetal heart rate monitoring lf any abnormalities will be detected the mother will be asked to change her position to the left lateral one The time needed for cervical dilatation the duration of each stage of labor and the mode of delivery will recorded After 6 h of delivery mother satisfaction will be assessed with the five-point Likerts scale as follows 1 for poor 2 for fair3 for good 4 for very good and 5 for excellent satisfaction The primary outcome will be the onset of analgesia while the secondary outcomes include the duration of analgesia hemodynamic changes labor progress and maternal complications Data will be entered tabulated and analyzed using SPSS version 26 After data entering baseline characteristics will be described as frequencies and percentages mean values and standard deviation SD or median and range For comparison of two independent groups of qualitative data Chi-Square test or Fishers exact test will be applied Besides Mann-Whitney U test and independent-samples test will be used to compare two groups of non-parametric and parametric quantitative data respectively P values 005 will be considered statistically significant for all of the used statistical tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None