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In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. 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
Hours prior to surgery
Before surgery
In the operation theater:
In group BF, 0.5% hyperbaric bupivacaine (ANAWIN heavy, Neon Laborotaries, India) 10 mg (2ml) with addition of 10mcg (0.2ml) fentanyl (TROFENTYL, Troikaa pharmaceuticals, India) with total volume of 2.2 ml will be prepared.
RR ≤10 breaths /min physical stimulus will be given (tapping a patient's shoulder with calling her name) If RR is still not increased or RR less than or equal to 8 breaths /min Inj Naloxone 0.4 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 following:6
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 and/or 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 mcg/kg.
After 2 doses of fentanyl, if pain still persists then Inj. Ketamine 0.5mcg/kg 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 scale)8
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine with Fentanyl (BF) | Active Comparator | In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml . 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. |
|
| Bupivacaine with Dexmedetomidine (BD) | Active Comparator | In patients undergoing elective LSCS under subarachnoid block, group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine | Drug | In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome | To compare the incidence of intraoperative visceral pain between participants of two groups. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | To compare occurrence of intraoperative shivering between participants of two groups. To compare the intraoperative systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate between two groups To compare the incidence of side effects like nausea, vomiting, respiratory depression, pruritus, between two groups To compare the neonatal APGAR score between two groups |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant female planned for elective C-section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujan Dhakal | Contact | 9851325896 | szndkl44@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sujan Dhakal | Ministry of health and population | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40765391 | Derived | Dhakal S, Shrestha M, Gautam E, Suwal A, Dhakal S, Dhakal S. Comparison of hyperbaric bupivacaine with fentanyl vs. hyperbaric bupivacaine with dexmedetomidine in reducing visceral pain during cesarean delivery under spinal anesthesia: study protocol. Pain Manag. 2025 Oct;15(10):651-658. doi: 10.1080/17581869.2025.2543232. Epub 2025 Aug 6. |
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Research method: Quantitative Type of study: Randomized, interventional, comparative study
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|
| Intraoperative |
| ID | Term |
|---|---|
| D059265 | Visceral Pain |
| ID | Term |
|---|---|
| D059226 | Nociceptive Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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