Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-11
Brief Title:
Comparison Between Hyperbaric Bupivacaine With Fentanyl vs Hyperbaric Bupivacaine With Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia
Sponsor:
Tribhuvan University Teaching Hospital Institute Of Medicine
Organization:
Tribhuvan University Teaching Hospital Institute Of Medicine
Study Overview
Official Title:
Comparison Between Hyperbaric Bupivacaine With Fentanyl vs Hyperbaric Bupivacaine With Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia A Prospective Randomised Double-Blind Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In patients undergoing elective LSCS under subarachnoid block group BF will receive 05 hyperbaric bupivacaine 10mg 2ml with fentanyl 10 mcg 02ml with total of 22 ml and group BD will receive 05 hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg 02ml total volume 22ml Assessment of intraoperative visceral pain will be done by self-reporting of patients who are previously educated as poorly localized discomfort or dragging pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale
Detailed Description:
Hours prior to surgery
All the patients included in the study will be explained in detail about the purpose of the study need benefits and risks of procedure
They will be instructed on the method used for sensory and motor assessments
In addition they will be explained about numerical rating scale of pain how to use it and rate it and about symptoms of the visceral pain if any during SAB in intraoperative period
Written informed consent will be obtained during pre-anaesthetic check-up
Fasting period will be ensured before taking to pre-operative room
Premedication will be done with Tab Pantoprazole 40 mg and Tab Metoclopramide 10 mg at 10 pm the day before surgery and 6 am in morning of surgery will be ensured
Before surgery
In pre-operative room a peripheral intravenous IV line will be established with 18-G IV cannula
Preloading will be done with 10 mlkg of Lactated Ringers solution
Baseline blood pressure mean arterial pressure heart rate respiratory rate SpO2 fetal heart rate will be recorded in pre-delivery room
In the operation theater
Standard monitor including electrocardiography non-invasive blood pressure monitoring and pulse oximetry will be attached
Patient will be positioned in sitting position
Painting of the patients back with 10 Povidine Iodine and draping with sterile drapes will be done
Identification of intervertebral space will be done by noting the location of the L4 spinous process on Tuffiers line line connecting the highest point of the iliac crests
Under all aseptic precautions the skin will be infiltrated with lidocaine 2 then a 25-gauge Quinckes spinal needle Spinocan B Braun medical Industries Malaysia will be introduced at L3-L4 or L4-L5 intervertebral space using a midline approach in sitting position
After ensuring free flow of cerebrospinal fluid study drug will be given over 12 - 15 sec
Study drugs would be prepared as follow In group BD 05 hyperbaric bupivacaine ANAWIN heavy Neon Laborotaries India 10mg 2ml with addition of 5 mcg 02ml Dexmedetomidine DEXTOMID Neon Laborotaries India with total volume of 22 ml will be prepared
In group BF 05 hyperbaric bupivacaine ANAWIN heavy Neon Laborotaries India 10 mg 2ml with addition of 10mcg 02ml fentanyl TROFENTYL Troikaa pharmaceuticals India with total volume of 22 ml will be prepared
Immediately after administration of spinal anesthesia patient will be positioned supine with wedge under right hip and the time will be recorded as time-zero
Fetal heart rates will be noted for any bradycardia
Patients will receive oxygen 3Lmin via nasal cannula if SpO2 decreases to 95
NIBP and HR will be assessed every 3-minute following SAB for 15 minutes or until delivery of baby and thereafter every 5 minutes till the end of surgery
SpO2 and ECG were monitored continuously throughout the study period
Hypotension will be promptly treated with intravenous fluid bolus 200 ml and Inj Mephentermine 6mg IV boluses which will be repeated if necessary
If bolus dose of Mephentermine exceeds 30mg then Inj Phenylephrine 50 mcg IV will be given
Inj Atropine 06mg will be given if bradycardia occurs
If respiratory depression occurs it will be recorded and managed as
RR 10 breaths min physical stimulus will be given tapping a patients shoulder with calling her name If RR is still not increased or RR less than or equal to 8 breaths min Inj Naloxone 04 mg IV will be given and will be repeated after 2-3 min if necessary Dose of Naloxone will not be exceeded 10mg day
Sensory level will be assessed bilaterally along the mid clavicular line using spirit-soaked cotton until block reached upto T6 dermatome and time will be noted
Motor block will be assessed based on Modified Bromage Scale and time will be noted
Surgery will be allowed as soon as upper sensory level reaches T6 and Bromage scale of M3
Thereafter the level will be checked every 2 min until maximal sensory block level is confirmed
Intra operative pain will be assessed whenever the patient complains of pain or discomfort during surgery
If somatic pain occurs at time of incision to skin or subcutaneous tissue spinal anesthesia will be converted to general anesthesia and excluded from study
Whenever visceral pain occur participants were encouraged to self-report such experience and were enquired every five minutes interval during surgery For analysis visceral pain outcome was categorized as following6
1 Excellent no complaints
2 Mild discomfort requiring no analgesic
3 Intermediate discomfort accompanied by nausea requiring anti-emetic
4 Severe discomfort accompanied by pain requiring analgesic and
5 Failed SA requiring GA
Assessment of visceral pain will be mainly done during Delivery of baby with fundal pressure application when pulling out the head of baby from uterus Exteriorization of uterus temporary extraction of uterus outside the abdominal cavity to facilitate uterine incision repair Handling of other intraperitoneal organs like bowels adenexa so as to clear off the secretions and blood Suturing of visceral peritoneum Placement of uterus back to abdominal cavity after repair
The occurrence of nausea was correlated with the decrement of SBP andor HR and addressed first
Nausea-vomiting occurring otherwise was treated with Ondansetron Metoclopramide and Dexamethasone as needed
Anxiety was addressed with Midazolam maximum three mg
Each time NRS is 4 or more it will be considered as inadequate analgesia7 and inj Fentanyl 25 mcg will be given IV bolus
We will wait for 3 min for its adequate effect
If still pain persists then the dose of fentanyl will be increased to 1 mcgkg
After 2 doses of fentanyl if pain still persists then Inj Ketamine 05mcgkg IV will be given
If still pain is unbearable general anesthesia will be administered
The need to convert to GA will be noted
Level of consciousness will be measured using sedation scale POSS scale8
Incidence of shivering will be noted during intraoperative period where temperature of OR will be kept between 18-21 degree Celsius
Occurrence of side effects such as nausea vomiting dizziness pruritus bradycardia decrease in SPO2 and respiratory rate will be recorded and treated according to severity
Any patients who will have these sign and symptoms will be assessed every 15 min in OR and recovery room
Following delivery of the baby Inj oxytocin 3 IU will be administered bolus
Continuous infusion of oxytocin drip will be given as per need after communicating with obstetrician
APGAR score of the neonate will be evaluated at 1 minute and 5 minutes
Weight of baby will be noted
Postoperatively patients will be monitored hourly for hemodynamic changes and for any side effects of study drugs upto 6hrs
All the patients included in the study will be explained in detail about the purpose of the study need benefits and risks of procedure
They will be instructed on the method used for sensory and motor assessments
In addition they will be explained about numerical rating scale of pain how to use it and rate it and about symptoms of the visceral pain if any during SAB in intraoperative period
Written informed consent will be obtained during pre-anaesthetic check-up
Fasting period will be ensured before taking to pre-operative room
Premedication will be done with Tab Pantoprazole 40 mg and Tab Metoclopramide 10 mg at 10 pm the day before surgery and 6 am in morning of surgery will be ensured
Before surgery
In pre-operative room a peripheral intravenous IV line will be established with 18-G IV cannula
Preloading will be done with 10 mlkg of Lactated Ringers solution
Baseline blood pressure mean arterial pressure heart rate respiratory rate SpO2 fetal heart rate will be recorded in pre-delivery room
In the operation theater
Standard monitor including electrocardiography non-invasive blood pressure monitoring and pulse oximetry will be attached
Patient will be positioned in sitting position
Painting of the patients back with 10 Povidine Iodine and draping with sterile drapes will be done
Identification of intervertebral space will be done by noting the location of the L4 spinous process on Tuffiers line line connecting the highest point of the iliac crests
Under all aseptic precautions the skin will be infiltrated with lidocaine 2 then a 25-gauge Quinckes spinal needle Spinocan B Braun medical Industries Malaysia will be introduced at L3-L4 or L4-L5 intervertebral space using a midline approach in sitting position
After ensuring free flow of cerebrospinal fluid study drug will be given over 12 - 15 sec
Study drugs would be prepared as follow In group BD 05 hyperbaric bupivacaine ANAWIN heavy Neon Laborotaries India 10mg 2ml with addition of 5 mcg 02ml Dexmedetomidine DEXTOMID Neon Laborotaries India with total volume of 22 ml will be prepared
In group BF 05 hyperbaric bupivacaine ANAWIN heavy Neon Laborotaries India 10 mg 2ml with addition of 10mcg 02ml fentanyl TROFENTYL Troikaa pharmaceuticals India with total volume of 22 ml will be prepared
Immediately after administration of spinal anesthesia patient will be positioned supine with wedge under right hip and the time will be recorded as time-zero
Fetal heart rates will be noted for any bradycardia
Patients will receive oxygen 3Lmin via nasal cannula if SpO2 decreases to 95
NIBP and HR will be assessed every 3-minute following SAB for 15 minutes or until delivery of baby and thereafter every 5 minutes till the end of surgery
SpO2 and ECG were monitored continuously throughout the study period
Hypotension will be promptly treated with intravenous fluid bolus 200 ml and Inj Mephentermine 6mg IV boluses which will be repeated if necessary
If bolus dose of Mephentermine exceeds 30mg then Inj Phenylephrine 50 mcg IV will be given
Inj Atropine 06mg will be given if bradycardia occurs
If respiratory depression occurs it will be recorded and managed as
RR 10 breaths min physical stimulus will be given tapping a patients shoulder with calling her name If RR is still not increased or RR less than or equal to 8 breaths min Inj Naloxone 04 mg IV will be given and will be repeated after 2-3 min if necessary Dose of Naloxone will not be exceeded 10mg day
Sensory level will be assessed bilaterally along the mid clavicular line using spirit-soaked cotton until block reached upto T6 dermatome and time will be noted
Motor block will be assessed based on Modified Bromage Scale and time will be noted
Surgery will be allowed as soon as upper sensory level reaches T6 and Bromage scale of M3
Thereafter the level will be checked every 2 min until maximal sensory block level is confirmed
Intra operative pain will be assessed whenever the patient complains of pain or discomfort during surgery
If somatic pain occurs at time of incision to skin or subcutaneous tissue spinal anesthesia will be converted to general anesthesia and excluded from study
Whenever visceral pain occur participants were encouraged to self-report such experience and were enquired every five minutes interval during surgery For analysis visceral pain outcome was categorized as following6
1 Excellent no complaints
2 Mild discomfort requiring no analgesic
3 Intermediate discomfort accompanied by nausea requiring anti-emetic
4 Severe discomfort accompanied by pain requiring analgesic and
5 Failed SA requiring GA
Assessment of visceral pain will be mainly done during Delivery of baby with fundal pressure application when pulling out the head of baby from uterus Exteriorization of uterus temporary extraction of uterus outside the abdominal cavity to facilitate uterine incision repair Handling of other intraperitoneal organs like bowels adenexa so as to clear off the secretions and blood Suturing of visceral peritoneum Placement of uterus back to abdominal cavity after repair
The occurrence of nausea was correlated with the decrement of SBP andor HR and addressed first
Nausea-vomiting occurring otherwise was treated with Ondansetron Metoclopramide and Dexamethasone as needed
Anxiety was addressed with Midazolam maximum three mg
Each time NRS is 4 or more it will be considered as inadequate analgesia7 and inj Fentanyl 25 mcg will be given IV bolus
We will wait for 3 min for its adequate effect
If still pain persists then the dose of fentanyl will be increased to 1 mcgkg
After 2 doses of fentanyl if pain still persists then Inj Ketamine 05mcgkg IV will be given
If still pain is unbearable general anesthesia will be administered
The need to convert to GA will be noted
Level of consciousness will be measured using sedation scale POSS scale8
Incidence of shivering will be noted during intraoperative period where temperature of OR will be kept between 18-21 degree Celsius
Occurrence of side effects such as nausea vomiting dizziness pruritus bradycardia decrease in SPO2 and respiratory rate will be recorded and treated according to severity
Any patients who will have these sign and symptoms will be assessed every 15 min in OR and recovery room
Following delivery of the baby Inj oxytocin 3 IU will be administered bolus
Continuous infusion of oxytocin drip will be given as per need after communicating with obstetrician
APGAR score of the neonate will be evaluated at 1 minute and 5 minutes
Weight of baby will be noted
Postoperatively patients will be monitored hourly for hemodynamic changes and for any side effects of study drugs upto 6hrs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None