Ignite Creation Date:
2024-05-06 @ 10:28 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03264430
Status:
UNKNOWN
Last Update Posted:
2018-01-17
First Post:
2017-05-29
Brief Title:
Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
Sponsor:
Esam Eldin Mohamed Abdalla
Organization:
Assiut University
Study Overview
Official Title:
Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal bupivavaine in selective saddle block for perianal surgery
Detailed Description:
This study will be carried out in Assiut University Hospitals General Surgery Operative room and Post Anaesthesia Care Unit PACU
This study will include 60 adult participants ASA III scheduled for minor perianal surgery perianal fistula haemorrhoids or both After approval of ethics committee and written informed consent will be obtained from the participants
Investigators will exclude participants with classic contraindications to spinal block pre-existing systemic disease such as cardiovascular respiratory or renal diseases coagulopathy and participants taking any medications that could influence the haemodynamic response
The selected participants will be divide into two groups 30 participants for each group ketamine group and placebo control group
The ketamine group will receive intrathecal bupivacaine 75 mg in 15 ml Marcaine Astra Zeneca France 05 and ketamine 25mg in 05 ml Ketam EIPICO Egypt 50 mgmL Total volume is 2 ml will injected The control group will receive only intrathecal bupivacaine 75 mg in 15 ml plus 05ml normal saline to achieve total volume of 2 ml
Anaesthetic technique
participants will receive oral medication 60 minutes preoperatively with 05 mgkg of midazolam
After arrival at the OR an intravenous IV 18-20G catheter was placed and infusion of 20 mlkg NaCl 09 will start Standard monitoring electrocardiogram ECG heart rate HR oxygen saturation SpO2 and non-invasive blood pressure BP will be started
Dural puncture was made in the sitting position with a 25 gauge spinal needle using a median approach After aspiration the dose of anaesthetic as indicated in the envelope was injected over two minutes The time of Dural puncture was used as the Primary starting point of assessment The medications injection will be over 10 s with no barbotage and the needle orifice cephaled After intrathecal injection participants will kept sitting for 10 minutes after that the patient will lie in the lithotomy position and received 100 O2 4 Lmin with face mask
Ten minutes after the Dural puncture participants will asked to lie down and the level of sensory block will tested with an alcohol swab Motor block was tested by modified Bromage scale 0 no motor block 1 able to flex ankle and bend knees 2 able to flex ankle and 3 full motor block 21 and surgery in the supine position will allow to started In case of failed block general anaesthesia will be induced
Non-invasive BP taken every 5 minutes and HR were assessed in the OR Reduction of mean BP MAP and HR 20 from baseline was judged clinically significant A decrease in systolic BP below 90 mmHg will be treated with 5 mg of IV ephedrine HR45 beats per minute bpm will be treated with 05 mg of IV atropine
Patient assessment
Demographics age gender type of surgery duration of anesthesia from the moment of dural puncture until patient left the OR and surgery in minutes
Rate of success failed block number of attempts made ease of performance scale 1-3 where 3 easy to perform 2 moderate 1 difficult multiple attempts needed
level of sensory dermatomes and motor Bromage scale block10 minutes after dural puncture at the end of surgery and in the ward every 30 minutes until resolution of the block and afterwards at 6 9 12 18 and 24 hours postoperatively
MAP and HR every 5 minutes in the OR then every 4 hours for postoperative 24 hours
Complications during performance of anesthesia paresthesias toxic reactions
Level of postoperative pain on a written VAS scale 0-10 mm
Time of 1st analgesic request and number of requests for each patient will be recorded in the 1st 24 hours
Consumption of rescue analgesia if VAS is 5 in the form of 30 mg intramuscular IM repeated twice as patient satisfaction and 01mg of morphine for up stocking of pain
Postoperative complications
- Urinary retention 0-2 scale where 0 normal urination 1 difficult spontaneous urination and 2 unable to urinate catheterization needed
Postoperative nausea and vomiting PONV 0-3 scale where 0 no nausea 1 slight nausea 2 nausea and single vomiting and 3 multiple vomiting 15
Postdural puncture headache PDPH at day 1 postoperatively and 10 days later by phone call at home
Transient neurologic symptoms TNS backache itching allergic reactions time of postoperative recovery time to urinate duration of sensory and motor block and time to stand and walk unsupported
Statistical analysis
The data will be recorded on and analyzed using SPSS-12 The results will be presented as Mean SD or percent of patients For proportions Pearson test or Fishers test will be used Students t-test being used for quantitative variables A p-value of 005 will be considered to show statistical significance
This study will include 60 adult participants ASA III scheduled for minor perianal surgery perianal fistula haemorrhoids or both After approval of ethics committee and written informed consent will be obtained from the participants
Investigators will exclude participants with classic contraindications to spinal block pre-existing systemic disease such as cardiovascular respiratory or renal diseases coagulopathy and participants taking any medications that could influence the haemodynamic response
The selected participants will be divide into two groups 30 participants for each group ketamine group and placebo control group
The ketamine group will receive intrathecal bupivacaine 75 mg in 15 ml Marcaine Astra Zeneca France 05 and ketamine 25mg in 05 ml Ketam EIPICO Egypt 50 mgmL Total volume is 2 ml will injected The control group will receive only intrathecal bupivacaine 75 mg in 15 ml plus 05ml normal saline to achieve total volume of 2 ml
Anaesthetic technique
participants will receive oral medication 60 minutes preoperatively with 05 mgkg of midazolam
After arrival at the OR an intravenous IV 18-20G catheter was placed and infusion of 20 mlkg NaCl 09 will start Standard monitoring electrocardiogram ECG heart rate HR oxygen saturation SpO2 and non-invasive blood pressure BP will be started
Dural puncture was made in the sitting position with a 25 gauge spinal needle using a median approach After aspiration the dose of anaesthetic as indicated in the envelope was injected over two minutes The time of Dural puncture was used as the Primary starting point of assessment The medications injection will be over 10 s with no barbotage and the needle orifice cephaled After intrathecal injection participants will kept sitting for 10 minutes after that the patient will lie in the lithotomy position and received 100 O2 4 Lmin with face mask
Ten minutes after the Dural puncture participants will asked to lie down and the level of sensory block will tested with an alcohol swab Motor block was tested by modified Bromage scale 0 no motor block 1 able to flex ankle and bend knees 2 able to flex ankle and 3 full motor block 21 and surgery in the supine position will allow to started In case of failed block general anaesthesia will be induced
Non-invasive BP taken every 5 minutes and HR were assessed in the OR Reduction of mean BP MAP and HR 20 from baseline was judged clinically significant A decrease in systolic BP below 90 mmHg will be treated with 5 mg of IV ephedrine HR45 beats per minute bpm will be treated with 05 mg of IV atropine
Patient assessment
Demographics age gender type of surgery duration of anesthesia from the moment of dural puncture until patient left the OR and surgery in minutes
Rate of success failed block number of attempts made ease of performance scale 1-3 where 3 easy to perform 2 moderate 1 difficult multiple attempts needed
level of sensory dermatomes and motor Bromage scale block10 minutes after dural puncture at the end of surgery and in the ward every 30 minutes until resolution of the block and afterwards at 6 9 12 18 and 24 hours postoperatively
MAP and HR every 5 minutes in the OR then every 4 hours for postoperative 24 hours
Complications during performance of anesthesia paresthesias toxic reactions
Level of postoperative pain on a written VAS scale 0-10 mm
Time of 1st analgesic request and number of requests for each patient will be recorded in the 1st 24 hours
Consumption of rescue analgesia if VAS is 5 in the form of 30 mg intramuscular IM repeated twice as patient satisfaction and 01mg of morphine for up stocking of pain
Postoperative complications
- Urinary retention 0-2 scale where 0 normal urination 1 difficult spontaneous urination and 2 unable to urinate catheterization needed
Postoperative nausea and vomiting PONV 0-3 scale where 0 no nausea 1 slight nausea 2 nausea and single vomiting and 3 multiple vomiting 15
Postdural puncture headache PDPH at day 1 postoperatively and 10 days later by phone call at home
Transient neurologic symptoms TNS backache itching allergic reactions time of postoperative recovery time to urinate duration of sensory and motor block and time to stand and walk unsupported
Statistical analysis
The data will be recorded on and analyzed using SPSS-12 The results will be presented as Mean SD or percent of patients For proportions Pearson test or Fishers test will be used Students t-test being used for quantitative variables A p-value of 005 will be considered to show statistical significance
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