To see whether adding a drug (dexmedetomidine)to the nerve block, provides longer period of pain relief after hip operation.
- Conditions
- Patient with hip fracture,undergoing operation.
- Registration Number
- CTRI/2018/02/012137
- Lead Sponsor
- SDM College of Medical Science And Hospitals
- Brief Summary
**Background:** Dexmeditomidine is a useful as additive to local anaesthetics in peripheral nerve block but whether it acts locally or after systemic absorption in not clear.
The aim of present study is to assess whether addition of dexmeditomidine prolongs duration of post-operative analgesia, when used along with local anaesthetics for USG guided Femoral nerve block and to test dexmeditomidine acting locally at peripheral nerve block or act after systemic absorption. The study is intended to compare the extent and quality of post-operative analgesia by ultrasound (USG) guided Femoral Nerve Block (FNB) with dexmeditomidine 50 mcg as an additive to 0.25% bupivacaine in affected limb in one (group B) , or USG guided femoral block with only local anaesthetic along with Intramuscular Dexmedetomidine 50 mcg in opposite limb in other group.
Methodology: The study is a prospective, double blind randomized clinical trial, approved from ethical committee and RGUHS
The study includes patients undergoing hip surgery with following inclusion criteria 1). Age 18-80 years 2.) ASA Physical status- I,II and III 4.) patient giving consent, Excluding patients with 1.)Polytrauma 2,)bleeding disorders and head injury 3.)Deformities of lumbar region 5.)Chronic alcoholic 6.)Patient on long term steroid and alpha agoinst use 6.)Patient not giving consent for regional anaesthesia.
All the patients will be preoperatively evaluated, optimized and necessary investigations will be carried out as per the need. They will be kept nil orally for 8 h before surgery and pre-medicated with oral alprazolam 0.25 mg and ranitidine 150 mg the night before surgery. In the operation theatre, after securing IV-line with18-gauge intravenous (IV) cannula, IV fluids will be started. The patients will be given SAB in sitting position using 26 G Quincke spinal needle at L3–L4 interspace with 12- 14 mg (2.4-2.8 mL) 0.5% hyperbaric bupivacaine after ensuring free flow of cerebrospinal fluid. After confirmation of adequate level, surgery will be allowed to proceed. Patients will not receive any additional analgesic in intraoperative period while anxious patients will be given intravenous midazolam 1 mg.
At the end of surgery, once spinal level recedes to T 12 level, USG-guided FNB will be given.
Patient selected as per inclusion criteria will randomized into either of the three groups using closed envelope technique into following group:
Group A: USG guided FNB with 40 ml (0.25 % bupivacaine +0.5 ml of NS) in affected lower limb and 0.5 ml NS as Intramuscular injection in opposite gluteal region.
Group B: USG guided FNB with 40 ml (0.25% bupivacaine + 50 mcg of dexmeditomidine) in affected limb and 0.5 ml NS as Intramuscular injection in opposite gluteal region
Group C: USG guided FNB with 40 cc (0.25 % bupivacaine) in affected limb and 50 mcg of dexmedetomidine as Intramuscular injection in opposite gluteal region
Blinding: Double bling, closed enveloped technique.
Following block, patients will be monitored in the post anaesthesia care unit (PACU) for two hours. Patient will be assessed every hourly in postoperative room and every 4th hourly, in the ward, till patient complains of pain with VAS score >3, intravenous Inj tramadol 50 mg will be given as rescue analgesia and analgesic requirement for next 24 hours will be assessed. If patient complains of nausea or vomiting, Inj ondansetron 4 mg will be given and . If Ramsay sedation score > 5, patient will be supplemented with oxygen via oxygen mask and monitored. If patient develop bradycardia HR <45, injection Atropine 0.6 mg i/v stat can be given and continued monitoring.
Primary outcome: Duration of analgesia after the block.
Secondary outcome: Total analgesic requirement in 24-hour, side effect.
Sample size :75
- Statistics analysis: Data will be analysed by rates, ratios, percentages and proportions.
- Chi-square test will be done for categorical data and one-way ANOVA for continuous data.
- Data will be analysed using SPSS software
P < 0.05 will be considered to be statistically significant. **Background:** Dexmeditomidine is a useful as additive to local anaesthetics in peripheral nerve block but whether it acts locally or after systemic absorption in not clear.
The aim of present study is to assess whether addition of dexmeditomidine prolongs duration of post-operative analgesia, when used along with local anaesthetics for USG guided Femoral nerve block and to test dexmeditomidine acting locally at peripheral nerve block or act after systemic absorption. The study is intended to compare the extent and quality of post-operative analgesia by ultrasound (USG) guided Femoral Nerve Block (FNB) with dexmeditomidine 50 mcg as an additive to 0.25% bupivacaine in affected limb in one (group B) , or USG guided femoral block with only local anaesthetic along with Intramuscular Dexmedetomidine 50 mcg in opposite limb in other group.
Methodology: The study is a prospective, double blind randomized clinical trial, approved from ethical committee and RGUHS
The study includes patients undergoing hip surgery with following inclusion criteria 1). Age 18-80 years 2.) ASA Physical status- I,II and III 4.) patient giving consent, Excluding patients with 1.)Polytrauma 2,)bleeding disorders and head injury 3.)Deformities of lumbar region 5.)Chronic alcoholic 6.)Patient on long term steroid and alpha agoinst use 6.)Patient not giving consent for regional anaesthesia.
All the patients will be preoperatively evaluated, optimized and necessary investigations will be carried out as per the need. They will be kept nil orally for 8 h before surgery and pre-medicated with oral alprazolam 0.25 mg and ranitidine 150 mg the night before surgery. In the operation theatre, after securing IV-line with18-gauge intravenous (IV) cannula, IV fluids will be started. The patients will be given SAB in sitting position using 26 G Quincke spinal needle at L3–L4 interspace with 12- 14 mg (2.4-2.8 mL) 0.5% hyperbaric bupivacaine after ensuring free flow of cerebrospinal fluid. After confirmation of adequate level, surgery will be allowed to proceed. Patients will not receive any additional analgesic in intraoperative period while anxious patients will be given intravenous midazolam 1 mg.
At the end of surgery, once spinal level recedes to T 12 level, USG-guided FNB will be given.
Patient selected as per inclusion criteria will randomized into either of the three groups using closed envelope technique into following group:
Group A: USG guided FNB with 40 ml (0.25 % bupivacaine +0.5 ml of NS) in affected lower limb and 0.5 ml NS as Intramuscular injection in opposite gluteal region.
Group B: USG guided FNB with 40 ml (0.25% bupivacaine + 50 mcg of dexmeditomidine) in affected limb and 0.5 ml NS as Intramuscular injection in opposite gluteal region
Group C: USG guided FNB with 40 cc (0.25 % bupivacaine) in affected limb and 50 mcg of dexmedetomidine as Intramuscular injection in opposite gluteal region
Blinding: Double bling, closed enveloped technique.
Following block, patients will be monitored in the post anaesthesia care unit (PACU) for two hours. Patient will be assessed every hourly in postoperative room and every 4th hourly, in the ward, till patient complains of pain with VAS score >3, intravenous Inj tramadol 50 mg will be given as rescue analgesia and analgesic requirement for next 24 hours will be assessed. If patient complains of nausea or vomiting, Inj ondansetron 4 mg will be given and . If Ramsay sedation score > 5, patient will be supplemented with oxygen via oxygen mask and monitored. If patient develop bradycardia HR <45, injection Atropine 0.6 mg i/v stat can be given and continued monitoring.
Primary outcome: Duration of analgesia after the block.
Secondary outcome: Total analgesic requirement in 24-hour, side effect.
Sample size :75
- Statistics analysis: Data will be analysed by rates, ratios, percentages and proportions.
- Chi-square test will be done for categorical data and one-way ANOVA for continuous data.
- Data will be analysed using SPSS software
P < 0.05 will be considered to be statistically significant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 75
- Age group: 18-80y.
- Belonging to ASA I, II and III.
- Scheduled to undergo surgery for hip surgery.
- Patient with : Poly trauma Head injury known cases of bleeding disorders,neuromuscular abnormalities Deformities of the lumbar region.
- Parents not willing to give consent for the study.
- Chronic alcoholic and long term steroid therapy.
- Consuming analgesics and adrenergic agonist or antagonist for a long time.
- Patient not giving consent for regional anaesthesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of first rescue analgesia after block Every 4th hours till analgesic requirement
- Secondary Outcome Measures
Name Time Method 24hour analgesic requirement Everly 4th hourly till 24 th hour.
Trial Locations
- Locations (1)
Operation Theatre, 2nd Floor, SDM College of Medical Science And Hospitals
🇮🇳Dharwad, KARNATAKA, India
Operation Theatre, 2nd Floor, SDM College of Medical Science And Hospitals🇮🇳Dharwad, KARNATAKA, IndiaCHETNA GOELPrincipal investigator9980615489chetnaseventeen@gmail.com