A Phase 2 interventional study of scalp block and infiltration in Headache, sponsored by NAVNEH SAMAGH. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-15.
Sponsored by NAVNEH SAMAGH · Phase 2, Interventional, and Prevention
This study has been designed to assess the efficacy of dexmedetomidine as an adjuvant to local anaesthetic agent bupivacaine in scalp nerve block and scalp infiltration to control post craniotomy pain.A third group where patients were administered bupivacaine only infiltration has also been created.
Patients were randomly allocated into three equal groups by computer generated random numbers. For randomization, the simple random allocation rule was followed, wherein the total sample size (n = 150) was randomly divided into three equal groups. In the event of any case has to be excluded because of requirement of postoperative ventilation, altered sensorium or high grade fever in the post-operative period, the same random number code was allocated to the next patient in order to ensure an equal sample size without any modification to the original random number table. The random numbers were then kept in opaque sealed envelopes, numbered sequentially which were opened just before shifting patient inside operation theatre.
The anaesthesiologist who prepared and administered the study drug were not involved in collection of data. The anaesthesiologist who collected the data from the patient in the postoperative period, the operating surgeon and the patient were blinded to the group assigned to the patient.
Pre-operative Assessment:
Pre-operative anaesthetic evaluation was done on the day prior to the surgery. This included a detailed history regarding physical health, any co-morbid illness, current medications, drug allergy and previous anaesthetic experience. The patient was made familiar about the NRS (0-10, with 0 = no pain, 10 = worst pain ever). A written and informed consent was taken. Patients were fasted and premedicated according to the departmental protocol.
Duration of study period-
Study period started after closure of skin incision of the scalp and continued till 48 hours in the postoperative period
Study groups-
Patients were randomly divided into three groups:
Group BI - Bupivacaine infiltration around surgical incision.
Group BDI - Bupivacaine and dexmedetomidine infiltration around surgical incision
Group BDNB- Bupivacaine and dexmedetomidine used in scalp nerve block.
Anaesthesia Technique-
A standard anaesthesia technique according to the departmental protocol was followed in all the patients. Pre-induction monitoring (Datex- Ohmeda S/5 Avance, Madison, WI, USA) consisted of 5-lead electrocardiography, heart rate, automated non-invasive blood pressure, and pulse oximetry. The patients were then be induced with propofol (1-2 mg/kg) or thiopentone (4-6mg/kg) and trachea were intubated with vecuronium 0.1 mg/kg. Anaesthesia was maintained with intravenous (propofol) or inhalational (isoflurane/sevoflurane/desflurane) anaesthetic agent along with nitrous oxide-oxygen mixture (60:40) and intermittent doses of intravenous vecuronium (0.02 mg/kg). Ventilation was maintained at ETCO2 30 to 35mm Hg. Total fresh gas flow rate was kept at 1-2 L/min. A radial artery catheter was inserted for continuous blood pressure monitoring and blood sampling if indicated. Intraoperative analgesia was maintained with intravenous morphine 0.1mg/kg and morphine repeated at a dose of 0.05 mg/kg if duration of surgery was more than 3 hours. Patients were reversed with neostigmine (0.05mg/kg) and glycopyrolate (0.01mg/kg) after administration of study drugs and were extubated once patient started responding to verbal commands and able to generate adequate tidal volume under spontaneous respiration.
Methods of postoperative analgesia- In all the patients, analgesic procedure was done ensuring proper aseptic precaution at the end of the surgery, after closure of skin incision and before putting the dressings over the incision. Patients were reversed from anaesthesia after the administration of study drugs.
Group BI: The incision site was infiltrated with 15-20 ml of bupivacaine (0.25%). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.
Group BDI: The incision site was infiltrated with 15-20 ml bupivacaine (0.25%) and dexmedetomedine (1 µg/kg). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.
Group BDNB: Scalp nerve blocks were given with15-20 ml of combination of Bupivacaine (0.25%) and Dexmedetomedine (1 µg/kg). Maximum dose of bupivacaine kept less than 2 mg /kg.
In this group following nerves were blocked-
Post-operative assessment:
After extubation patients were shifted to the Post anaesthesia care unit (PACU) and assessed for haemodynamic parameters, sedation and any complication at 15 minutes interval till 2hrs and then at 4, 8, 12, 16, 20, 24, 36 and 48 hours. Assessed for cognitive function at 30 min and 60 min.
Patients were followed after discharge for 6 months by telephonic communication at 1, and 3 month interval for presence of chronic pain.
COLLECTION OF DATA-
Preoperative- Age, sex, weight, ASA status, diagnosis, surgery
Intraoperative-
Postoperative-
Cognitive function- Patients were evaluated for cognitive function 30 minutes after shifting to PACU using a modified self-devised questionnaire of short orientation memory concentration test.
Whenever the subjects were able to recall and count with minimal mistakes (1 to 3), were regarded as good, with more than 3 mistakes as fair, and if not be able to recall at all, it was regarded as poor. If the cognitive function outcome was poor then same test was repeated at 1 hour after shifting to PACU. If outcome was again poor, then that patient was excluded from the study.
Adverse events-
1,226 studies on the registry are indexed under Headache; 202 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 918 interventional studies indexed under Headache.
Browse Headache studies →This is the only study on the registry with NAVNEH SAMAGH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Following patients were excluded from the study during collection of data in the postoperative period:-
Bupivacaine (0.25%) and Dexmedetomedine (1 µg/kg). Maximum dose of bupivacaine kept \< 2 mg /kg for scalp block
Procedure: scalp block · Drug: Dexmedetomidine · Drug: Bupivacaine
The incision site was infiltrated with 15-20 ml bupivacaine (0.25%) and dexmedetomedine (1 µg/kg). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.
Procedure: infiltration · Drug: Dexmedetomidine · Drug: Bupivacaine
The incision site was infiltrated with 15-20 ml of bupivacaine (0.25%). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.
Procedure: infiltration · Drug: Bupivacaine
In this group following nerves were blocked- 1. Supra-orbital nerve 2. Supra-trochlear nerve 3. Zygomatico-temporal nerve 4. Auriculo-temporal nerve 5. Posterior auricular branches of the greater auricular Nerve 6. The greater, lesser, and third occipital nerves
The incision site was infiltrated with drug. {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}.
Dexmedetomidine was administered as a dose of 1 µg/kg in 20 ml 0.25% bupivacaine for scalp block or infiltration.
Also known as: Precedex, Dexdor
20 ml of Bupivacaine 0.25% was administered to the patients either in the form of scalp block or infiltration
Also known as: Marcaine, Sensorcaine, Marcain
post craniotomy pain by Numerical rating scale (NRS)
Numerical rating scale (NRS) is a scale from 0 to 10 where 0 shows 'no pain' and 10 shows 'worst imaginable excruciating pain
Time frame: Immediately after extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 30 minutes after extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 1 hour after extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 1.5 hours after extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 2 hours after extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 4 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 8 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 12 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 16 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 20 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 24 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 36 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)
Time frame: 48 hours post extubation
chronic pain using Numerical rating scale (NRS)
Numerical rating scale (NRS) is a scale from 0 to 10 where 0 shows 'no pain' and 10 shows 'worst imaginable excruciating pain
Time frame: 1 month
chronic pain using Numerical rating scale (NRS)
Time frame: 3 months
post operative sedation using Modified Ramsay Sedation Scale
Sedation Score-- by Modified Ramsay Sedation Scale 1. Anxious/ Agitated/ Restless 2. Cooperative/ Oriented/ Tranquil 3. Responds to verbal commands 4. Brisk response to light glabellar tap or loud noise 5. Sluggish response to light glabellar tap or loud noise 6. No Response
Time frame: 15 minutes interval till 2hrs post extubation and then at 4, 8, 12, 16, 20, 24, 36 and 48 hours.
post operative sedation using Modified Ramsay Sedation Scale
Sedation Score-- by Modified Ramsay Sedation Scale 1. Anxious/ Agitated/ Restless 2. Cooperative/ Oriented/ Tranquil 3. Responds to verbal commands 4. Brisk response to light glabellar tap or loud noise 5. Sluggish response to light glabellar tap or loud noise 6. No Response
Time frame: 4 hours
post operative sedation using Modified Ramsay Sedation Scale
Sedation Score-- by Modified Ramsay Sedation Scale 1. Anxious/ Agitated/ Restless 2. Cooperative/ Oriented/ Tranquil 3. Responds to verbal commands 4. Brisk response to light glabellar tap or loud noise 5. Sluggish response to light glabellar tap or loud noise 6. No Response
Time frame: 8 hours.
post operative sedation using Modified Ramsay Sedation Scale
Sedation Score-- by Modified Ramsay Sedation Scale 1. Anxious/ Agitated/ Restless 2. Cooperative/ Oriented/ Tranquil 3. Responds to verbal commands 4. Brisk response to light glabellar tap or loud noise 5. Sluggish response to light glabellar tap or loud noise 6. No Response
Time frame: 12 hours.
post operative sedation using Modified Ramsay Sedation Scale
Sedation Score-- by Modified Ramsay Sedation Scale 1. Anxious/ Agitated/ Restless 2. Cooperative/ Oriented/ Tranquil 3. Responds to verbal commands 4. Brisk response to light glabellar tap or loud noise 5. Sluggish response to light glabellar tap or loud noise 6. No Response
Time frame: 16 hours.
post operative sedation using Modified Ramsay Sedation Scale
Sedation Score-- by Modified Ramsay Sedation Scale 1. Anxious/ Agitated/ Restless 2. Cooperative/ Oriented/ Tranquil 3. Responds to verbal commands 4. Brisk response to light glabellar tap or loud noise 5. Sluggish response to light glabellar tap or loud noise 6. No Response
Time frame: 20 hours.
post operative sedation using Modified Ramsay Sedation Scale
Sedation Score-- by Modified Ramsay Sedation Scale 1. Anxious/ Agitated/ Restless 2. Cooperative/ Oriented/ Tranquil 3. Responds to verbal commands 4. Brisk response to light glabellar tap or loud noise 5. Sluggish response to light glabellar tap or loud noise 6. No Response
Time frame: 24 hours.
post operative sedation using Modified Ramsay Sedation Scale
Sedation Score-- by Modified Ramsay Sedation Scale 1. Anxious/ Agitated/ Restless 2. Cooperative/ Oriented/ Tranquil 3. Responds to verbal commands 4. Brisk response to light glabellar tap or loud noise 5. Sluggish response to light glabellar tap or loud noise 6. No Response
Time frame: 36 hours.
post operative sedation using Modified Ramsay Sedation Scale
Sedation Score-- by Modified Ramsay Sedation Scale 1. Anxious/ Agitated/ Restless 2. Cooperative/ Oriented/ Tranquil 3. Responds to verbal commands 4. Brisk response to light glabellar tap or loud noise 5. Sluggish response to light glabellar tap or loud noise 6. No Response
Time frame: 48 hours.
rescue analgesic requirement in grams
total rescue analgesic requirement in grams of paracetamol consumed in 24 hours
Time frame: 24 hrs
rescue analgesic requirement in grams
total rescue analgesic requirement in grams of paracetamol consumed in 48 hours
Time frame: 48 hrs
heart rate in beats per minute(bpm)
15 minutes interval till 2hrs post extubation
Time frame: 15 minutes interval till 2hrs
heart rate in beats per minute(bpm)
Time frame: 4 hours.
heart rate in beats per minute(bpm)
Time frame: 8 hours.
heart rate in beats per minute(bpm)
Time frame: 12 hours.
heart rate in beats per minute(bpm)
Time frame: 16 hours.
heart rate in beats per minute(bpm)
Time frame: 20 hours.
heart rate in beats per minute(bpm)
Time frame: 24 hours.
heart rate in beats per minute(bpm)
Time frame: 36 hours.
heart rate in beats per minute(bpm)
Time frame: 48 hours.
systolic blood pressure in mm of Hg
15 minutes interval till 2hrs post extubation
Time frame: 15 minutes interval till 2hrs
systolic blood pressure in mm of Hg
Time frame: 4 hours.
systolic blood pressure in mm of Hg
Time frame: 8 hours.
systolic blood pressure in mm of Hg
Time frame: 12 hours.
systolic blood pressure in mm of Hg
Time frame: 16 hours.
systolic blood pressure in mm of Hg
Time frame: 20 hours.
systolic blood pressure in mm of Hg
Time frame: 24 hours.
systolic blood pressure in mm of Hg
Time frame: 36 hours.
systolic blood pressure in mm of Hg
Time frame: 48 hours.
Diastolic blood pressure in mm of Hg
15 minutes interval till 2hrs post extubation
Time frame: 15 minutes interval till 2hrs
Diastolic blood pressure in mm of Hg
Time frame: 4 hours.
Diastolic blood pressure in mm of Hg
Time frame: 8 hours.
Diastolic blood pressure in mm of Hg
Time frame: 12 hours.
Diastolic blood pressure in mm of Hg
Time frame: 16 hours.
Diastolic blood pressure in mm of Hg
Time frame: 20 hours.
Diastolic blood pressure in mm of Hg
Time frame: 24 hours.
Diastolic blood pressure in mm of Hg
Time frame: 36 hours.
Diastolic blood pressure in mm of Hg
Time frame: 48 hours.
SpO2 in percentage
Time frame: 15 minutes interval till 2hours.
SpO2 in percentage
Time frame: 4 hours.
SpO2 in percentage
Time frame: 8 hours.
SpO2 in percentage
Time frame: 12 hours.
SpO2 in percentage
Time frame: 16 hours.
SpO2 in percentage
Time frame: 20 hours.
SpO2 in percentage
Time frame: 24 hours.
SpO2 in percentage
Time frame: 36 hours.
SpO2 in percentage
Time frame: 48 hours.
respiratory rate in breaths per minute
respiratory rate in breaths per minute at 15 minutes interval till 2hrs in post operative period after extubation
Time frame: 15 minutes interval till 2hrs
respiratory rate in breaths per minute
Time frame: 4 hours.
Respiratory rate in breaths per minute
Time frame: 8 hours.
Respiratory rate in breaths per minute
Time frame: 12 hours.
Respiratory rate in breaths per minute
Time frame: 16 hours.
Respiratory rate in breaths per minute
Time frame: 20 hours.
Respiratory rate in breaths per minute
Time frame: 24 hours.
Respiratory rate in breaths per minute
Time frame: 36 hours.
Respiratory rate in breaths per minute
Time frame: 48 hours.
cognitive function using Modified self-devised questionnaire of short orientation memory concentration
Modified self-devised questionnaire of short orientation memory concentration test 1. What date is it today? 2. What is the current year? 3. What is his/her birthday? 4. Count numbers 1 to 10. 5. Count reverse numbers from 10 to 1.
Time frame: 30 minutes
cognitive function using Modified self-devised questionnaire of short orientation memory concentration
Modified self-devised questionnaire of short orientation memory concentration test 1. What date is it today? 2. What is the current year? 3. What is his/her birthday? 4. Count numbers 1 to 10. 5. Count reverse numbers from 10 to 1.
Time frame: 60 minutes
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale
Postoperative Nausea and Vomiting Scale 1. No PONV: Absence of any emesis or nausea. 2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required. 3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required. 4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice \& more than one antiemetic required.
Time frame: 15 minutes interval till 2hrs
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale
Postoperative Nausea and Vomiting Scale 1. No PONV: Absence of any emesis or nausea. 2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required. 3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required. 4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice \& more than one antiemetic required.
Time frame: 4 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale
Postoperative Nausea and Vomiting Scale 1. No PONV: Absence of any emesis or nausea. 2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required. 3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required. 4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice \& more than one antiemetic required.
Time frame: 8 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale
Postoperative Nausea and Vomiting Scale 1. No PONV: Absence of any emesis or nausea. 2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required. 3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required. 4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice \& more than one antiemetic required.
Time frame: 12 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale
Postoperative Nausea and Vomiting Scale 1. No PONV: Absence of any emesis or nausea. 2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required. 3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required. 4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice \& more than one antiemetic required.
Time frame: 16 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale
Postoperative Nausea and Vomiting Scale 1. No PONV: Absence of any emesis or nausea. 2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required. 3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required. 4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice \& more than one antiemetic required.
Time frame: 20 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale
Postoperative Nausea and Vomiting Scale 1. No PONV: Absence of any emesis or nausea. 2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required. 3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required. 4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice \& more than one antiemetic required.
Time frame: 24 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale
Postoperative Nausea and Vomiting Scale 1. No PONV: Absence of any emesis or nausea. 2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required. 3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required. 4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice \& more than one antiemetic required.
Time frame: 36 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale
Postoperative Nausea and Vomiting Scale 1. No PONV: Absence of any emesis or nausea. 2. Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required. 3. Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required. 4. Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice \& more than one antiemetic required.
Time frame: 48 hours.
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