Labor AnalgesiaNCT06550414
Dexmedetomidine As An Adjuvant To Bupivacaine 0.1% in Labor Analgesia
A study testing Dexmedetomidine and Bupivacain in people with Labor Analgesia and Labor Pain, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Analgesia, Labor Pain
- What is being tested?
- Dexmedetomidine and Bupivacain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 1 May 2023
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients in 37 or more weeks of pregnancy,
- having a single pregnancy with vertex presentation
- without any significant systemic disease will be included in the study.
Who cannot join
- Patients with mal-presentation
- twin pregnancy
- preeclampsia,
- uncontrolled systemic comorbidities
- diabetes, renal, hepatic, or cardiac.
- bleeding, diathesis, body mass index (BMl) more than 35 kg/m2
- known allergy to any of the study drugs will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Use of Dexmedetomidine as an Adjuvant to Bupivacaine 0.1% in Labor Analgesia.
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.
Read the detailed description
Objectives of this study are to evaluate the efficacy of adding dexmedetomidine in labor epidurals with 0.1% bupivacaine in females undergoing normal vaginal delivery.
OPERATIONAT DEFINITIONS:
- Onset of Analgesia: Time required to attain a VAS of less than or equal to 3 after giving loading dose
- Duration of Analgesia. Time after loading dose till the VAS >3 or break-through pain reported by the mother.
- 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 0.05 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 0.1% (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 increments/s min). This will be followed by continuous infusion of bupivacaine 0.1% (at 10 ml/h 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 Hartman's 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 2%.The 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 4.5-5.5 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 VAS>3 or break-through pain will be reported by the patient then a top-up dose of bupivacaine 0.1% (10 ml)will 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.
- 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, 30,45, 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 beats/m, and will be managed by intravenous 0.5 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 Likert's scale as follows: 1 for poor, 2 for fair,3 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 Fisher's 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 < 0.05 will be considered statistically significant for all of the used statistical tests
- Conditions
- Labor Analgesia, Labor Pain
- Being tested
- Dexmedetomidine, Bupivacain
- Keywords
- bupivacaine, Dexmedetomidine, Labor analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Labor analgesia
Active comparator: dexmedetomidine group
BupivacainDrug
Also called Labor analgesia
Placebo comparator: bupivacaine group
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine group | Placebo comparator | group given 0.1% bupivacaine 10ml as loading dose in labor epidural. Receives: Drug: Bupivacain |
| dexmedetomidine group | Active comparator | group given 50 micrograms of dexmedetomidine along with 0.1% bupivacaine in labor analgesia dose. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset of analgesia
time noted for onset of analgesia in both groups
Measured: Patient observed for 45 minutes after drug delivery and time required to achieve a VAS of 3 or less than 3 is noted down.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Nov 2022
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor AnalgesiaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, dr. sana siddiq, Services Institute of Medical Sciences, Pakistan
- Investigators
- Siddiq, Principal investigator, Hameed lateef hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550414
- Sponsor's protocol ID
- HLH
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Use of Dexmedetomidine as an Adjuvant to Bupivacaine 0.1% in Labor Analgesia.
- ClinicalTrials.gov ID
- NCT06550414
- Acronym / sponsor ID
- HLH
- Conditions
- Labor Analgesia, Labor Pain
- Keywords
- bupivacaine, Dexmedetomidine, Labor analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 13 Aug 2024 (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.
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.
Detailed description
Objectives of this study are to evaluate the efficacy of adding dexmedetomidine in labor epidurals with 0.1% bupivacaine in females undergoing normal vaginal delivery.
OPERATIONAT DEFINITIONS:
- Onset of Analgesia: Time required to attain a VAS of less than or equal to 3 after giving loading dose
- Duration of Analgesia. Time after loading dose till the VAS >3 or break-through pain reported by the mother.
- 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 0.05 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 0.1% (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 increments/s min). This will be followed by continuous infusion of bupivacaine 0.1% (at 10 ml/h 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 Hartman's 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 2%.The 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 4.5-5.5 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 VAS>3 or break-through pain will be reported by the patient then a top-up dose of bupivacaine 0.1% (10 ml)will 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.
- 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, 30,45, 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 beats/m, and will be managed by intravenous 0.5 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 Likert's scale as follows: 1 for poor, 2 for fair,3 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 Fisher's 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 < 0.05 will be considered statistically significant for all of the used statistical tests
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| bupivacaine group | Placebo comparator | Drug: Bupivacaingroup given 0.1% bupivacaine 10ml as loading dose in labor epidural. |
| dexmedetomidine group | Active comparator | Drug: Dexmedetomidinegroup given 50 micrograms of dexmedetomidine along with 0.1% bupivacaine in labor analgesia dose. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients in 37 or more weeks of pregnancy,
- having a single pregnancy with vertex presentation
- without any significant systemic disease will be included in the study.
Key exclusion criteria (7 listed)
- Patients with mal-presentation
- twin pregnancy
- preeclampsia,
- uncontrolled systemic comorbidities
- diabetes, renal, hepatic, or cardiac.
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 |
|---|---|---|
| DexmedetomidineAlso: Labor analgesiaActive comparator: dexmedetomidine group | Drug | dexmedetomidine group |
| BupivacainAlso: Labor analgesiaPlacebo comparator: bupivacaine group | Drug | bupivacaine group |
Primary outcome
onset of analgesia
Time frame: Patient observed for 45 minutes after drug delivery and time required to achieve a VAS of 3 or less than 3 is noted down.
time noted for onset of analgesia in both groups
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 13 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Siddiq principal investigator
Hameed lateef hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Bupivacain in people with Labor Analgesia and Labor Pain, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
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 3 inclusion and 7 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 13 Aug 2024. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
onset of analgesia (time frame: Patient observed for 45 minutes after drug delivery and time required to achieve a VAS of 3 or less than 3 is noted down.). 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 13 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.