Postoperative Pain
Conditions
Keywords
magnesium sulphate, intrathecal route, midazolam
Brief summary
This study compares whether addition of Magnesium or Midazolam intrathecally to epidurally administered isobaric Ropivacaine improves the quality of blockade, haemodynamics and duration of analgesia post-operatively. 25 parturients were given intrathecal Magnesium and rest of the 25 parturients were given intrathecal Midazolam combined with 0.75% Ropivacaine via epidural route.
Detailed description
Magnesium sulphate and Midazolam have been used in clinical trials as adjuvants to local anaesthetics via intrathecal and epidural routes and are effective in augmenting the quality of block and prolonging post-operative analgesia. Noxious stimulation leads to the release of glutamate and aspartate neuratransmitters which bind to various sub-classes of excitatory aminoacid, including the NMDA receptor. Intrathecal magnesium potentiates neuraxial anaesthesia by blocking NMDA receptors with out causing significant side effects as reported in various studies. Intrathecal Midazolam produces antinociception at spinal cord-level through benzodiazepine GABA-A receptor complex which are present abundantly in the lamina 2 of spinal cord. Midazolam also releases endogenous opioid acting at spinal delta receptors and also enhances adenosine release which also augments analgesia.
Interventions
DRUGintrathecal magnesium sulphate,
comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
DRUGIntrathecal midazolam
comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
Sponsors
Rangaraya Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 28 Years
Healthy volunteers
Yes
Inclusion criteria
* 50 pregnant women * ASA-I and II parturients * Weight 50-80 kgs * Pre-eclampsia
Exclusion criteria
* Thrombocytopenia * HELLP syndrome * Parturients on magnesium therapy * Foetal distress * Parturients on benzodiazepine therapy * Patient refusal * Contraindications to regional anaesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Postoperative Analgesia | first 12 hours after completion of surgery. | pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Sensory Blockade | every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery.. | the onset time of sensory blockade was assessed with pinprick . |
| Duration of Sensory Blockade | every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery.. | the duration of sensory blockade was assessed with pinprick . |
| Onset of Motor Blockade | every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery. | assessed with modified bromage scale. |
| Duration of Motor Blockade | every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery. | assessed with modified bromage scale. |
| Perioperative Side Effects | through out the intraoperative period and first 12 postoperative hours. | through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GROUP A(MAGNESIUM GROUP) MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine | 25 |
| GROUP B(MIDAZOLAM GROUP) MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | GROUP A(MAGNESIUM GROUP) | GROUP B(MIDAZOLAM GROUP) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| age in years | 23 years STANDARD_DEVIATION 2 | 26 years STANDARD_DEVIATION 3 | 24.5 years STANDARD_DEVIATION 2.5 |
| height in centimeters | 156 centimeters STANDARD_DEVIATION 3 | 158 centimeters STANDARD_DEVIATION 6 | 157 centimeters STANDARD_DEVIATION 4.5 |
| Sex/Gender, Customized female pregnant patients | 25 participants | 25 participants | 50 participants |
| weight in kilograms | 68 kilograms STANDARD_DEVIATION 5 | 72 kilograms STANDARD_DEVIATION 6 | 70 kilograms STANDARD_DEVIATION 5.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 25 | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Duration of Postoperative Analgesia
pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.
Time frame: first 12 hours after completion of surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GROUP A(MAGNESIUM GROUP) | Duration of Postoperative Analgesia | 334 time in minutes | Standard Deviation 39 |
| GROUP B(MIDAZOLAM GROUP) | Duration of Postoperative Analgesia | 280 time in minutes | Standard Deviation 23.4 |
Secondary
Duration of Motor Blockade
assessed with modified bromage scale.
Time frame: every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GROUP A(MAGNESIUM GROUP) | Duration of Motor Blockade | 265 time in minutes | Standard Deviation 24.6 |
| GROUP B(MIDAZOLAM GROUP) | Duration of Motor Blockade | 223 time in minutes | Standard Deviation 22.2 |
Secondary
Duration of Sensory Blockade
the duration of sensory blockade was assessed with pinprick .
Time frame: every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GROUP A(MAGNESIUM GROUP) | Duration of Sensory Blockade | 295 time in minutes | Standard Deviation 36 |
| GROUP B(MIDAZOLAM GROUP) | Duration of Sensory Blockade | 245 time in minutes | Standard Deviation 26.4 |
Secondary
Onset of Motor Blockade
assessed with modified bromage scale.
Time frame: every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GROUP A(MAGNESIUM GROUP) | Onset of Motor Blockade | 12.5 time in minutes | Standard Deviation 1.6 |
| GROUP B(MIDAZOLAM GROUP) | Onset of Motor Blockade | 7.68 time in minutes | Standard Deviation 3.2 |
Secondary
Onset of Sensory Blockade
the onset time of sensory blockade was assessed with pinprick .
Time frame: every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GROUP A(MAGNESIUM GROUP) | Onset of Sensory Blockade | 9.86 time in minutes | Standard Deviation 1.37 |
| GROUP B(MIDAZOLAM GROUP) | Onset of Sensory Blockade | 7.93 time in minutes | Standard Deviation 0.87 |
Secondary
Perioperative Side Effects
through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering.
Time frame: through out the intraoperative period and first 12 postoperative hours.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GROUP A(MAGNESIUM GROUP) | Perioperative Side Effects | Nausea and vomiting | 2 participants |
| GROUP A(MAGNESIUM GROUP) | Perioperative Side Effects | shivering | 1 participants |
| GROUP B(MIDAZOLAM GROUP) | Perioperative Side Effects | Nausea and vomiting | 3 participants |
| GROUP B(MIDAZOLAM GROUP) | Perioperative Side Effects | shivering | 3 participants |