Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419556
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-14
Brief Title:
Analgesic Efficacy of an Intermediate CPB in Neck Surgeries
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Analgesic Efficacy of an Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries A Comparison Between Two Bupivacaine Concentrations
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
This study aims to investigate the analgesic efficacy of Intermediate Cervical Plexus Block combined with GA using two bupivacaine concentrations in patients undergoing neck surgeries total thyroidectomy or total laryngectomy
Detailed Description:
This randomized comparative study was conducted in Cairo University hospitals after the approval of the institutional research and ethics committee Informed consent was obtained from all participants The Consolidated Standards of Reporting Trials CONSORT Guidelines were followed
The patients were randomly allocated into two groups H L using computer generated random numbers that were concealed in opaque envelopes Group H received 20 ml 025 bupivacaine and Group L received 20 ml 0125 bupivacaine bilaterally
On arrival to the operating room an 18G cannula was inserted with the infusion of 500 ml Ringer solution Controloc 40 mg ondansetron 8 mg and dexamethasone 8 mg were administered as premedication The diaphragmatic motion was assessed by a 35 MHz curvilinear transducer siemens ACUSON X300 ultrasound Each hemidiaphragm was first visualized by B-mode then M-mode was used to evaluate diaphragmatic excursion For the right hemidiaphragm the transducer was placed perpendicularly over the right subcostal margin in the anterior axillary line the prob was then directed cephalad and dorsally to reach the posterior one-third of the diaphragm Diaphragmatic excursions were measured and recorded in millimeters using the liver as an acoustic window during quiet breathing The left hemidiaphragm was assessed in the same way using the spleen as an acoustic window
All patients connected to an electrocardiograph ECG pulse oximeter and non-invasive blood pressure NIBP and baseline values of HR and MAP were measured and recorded Additional monitoring in the form of a capnogram invasive blood pressure IBP through a radial artery cannula peripheral nerve stimulator PNS Bispectral index BIS and urine output were connected after induction of GA Anesthesia was induced by intravenous fentanyl 2µgkg propofol 15-2 mgkg and atracurium 05 mg When the TOF count showed the disappearance of T1 04 an appropriate-size endotracheal tube was inserted and secured Under complete aseptic conditions ultrasound guided bilateral ICPB was performed by a single staff anesthetist who is skilled in carrying out regional anesthesia
ICPB technique The patients head was rested on a pillow and turned to the opposite side A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle The carotid artery was identified and traced upwards to its bifurcation the probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle Via an in-plane technique a 22-gauge 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the pop on piercing the investing fascia was felt The patient was then randomly allocated into two groups H L using computer generated random numbers that were concealed in opaque envelopes Group H received 20 ml 025 bupivacaine and Group L received 20 ml 0125 bupivacaine The technique was repeated on the opposite side
During the intraoperative period anesthesia was maintained with isoflurane 12-15 vol to keep BIS value at 40-60 and atracurium 01mgkg guided by PNS Additional doses of fentanyl 005 µgkg were administered when HR or MAP increased 20 of the baseline values MAP and HR were measured after the skin incision and then every 30 minutes till the end of surgery The failed block was considered when four additional doses of fentanyl were required to manage the increased MAP or HR after skin incision At the end of the surgery one gram of paracetamol plus 30 mg of ketorolac were administered
During the postoperative period regular analgesia in the form of intravenous paracetamol one gram8hr was prescribed Pain severity was assessed by using the visual analog scale VAS 0 no pain and 100mm worst pain at 2 4 6 8 12 18 and 24 hr postoperatively Rescue analgesia in the form of intravenous morphine 005 mgkg was given on the patients complaint or when VAS 40 mm and repeated every 15-20 minutes until VAS 40 mm with a maximum morphine dose of 40 mg per 24 hours The duration of analgesia was calculated as the time elapsed from the end of the ICPB block procedure till VAS 40mm The total postoperative morphine consumption over 24 hours was calculated The measurement of diaphragmatic excursions was repeated as mentioned above hemi-diaphragmatic paresis was divided into three grades depending on the percentage of diaphragm movement compared with baseline to be none 75 partial paresis 25-75 and complete paresis 25
The patients were randomly allocated into two groups H L using computer generated random numbers that were concealed in opaque envelopes Group H received 20 ml 025 bupivacaine and Group L received 20 ml 0125 bupivacaine bilaterally
On arrival to the operating room an 18G cannula was inserted with the infusion of 500 ml Ringer solution Controloc 40 mg ondansetron 8 mg and dexamethasone 8 mg were administered as premedication The diaphragmatic motion was assessed by a 35 MHz curvilinear transducer siemens ACUSON X300 ultrasound Each hemidiaphragm was first visualized by B-mode then M-mode was used to evaluate diaphragmatic excursion For the right hemidiaphragm the transducer was placed perpendicularly over the right subcostal margin in the anterior axillary line the prob was then directed cephalad and dorsally to reach the posterior one-third of the diaphragm Diaphragmatic excursions were measured and recorded in millimeters using the liver as an acoustic window during quiet breathing The left hemidiaphragm was assessed in the same way using the spleen as an acoustic window
All patients connected to an electrocardiograph ECG pulse oximeter and non-invasive blood pressure NIBP and baseline values of HR and MAP were measured and recorded Additional monitoring in the form of a capnogram invasive blood pressure IBP through a radial artery cannula peripheral nerve stimulator PNS Bispectral index BIS and urine output were connected after induction of GA Anesthesia was induced by intravenous fentanyl 2µgkg propofol 15-2 mgkg and atracurium 05 mg When the TOF count showed the disappearance of T1 04 an appropriate-size endotracheal tube was inserted and secured Under complete aseptic conditions ultrasound guided bilateral ICPB was performed by a single staff anesthetist who is skilled in carrying out regional anesthesia
ICPB technique The patients head was rested on a pillow and turned to the opposite side A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle The carotid artery was identified and traced upwards to its bifurcation the probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle Via an in-plane technique a 22-gauge 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the pop on piercing the investing fascia was felt The patient was then randomly allocated into two groups H L using computer generated random numbers that were concealed in opaque envelopes Group H received 20 ml 025 bupivacaine and Group L received 20 ml 0125 bupivacaine The technique was repeated on the opposite side
During the intraoperative period anesthesia was maintained with isoflurane 12-15 vol to keep BIS value at 40-60 and atracurium 01mgkg guided by PNS Additional doses of fentanyl 005 µgkg were administered when HR or MAP increased 20 of the baseline values MAP and HR were measured after the skin incision and then every 30 minutes till the end of surgery The failed block was considered when four additional doses of fentanyl were required to manage the increased MAP or HR after skin incision At the end of the surgery one gram of paracetamol plus 30 mg of ketorolac were administered
During the postoperative period regular analgesia in the form of intravenous paracetamol one gram8hr was prescribed Pain severity was assessed by using the visual analog scale VAS 0 no pain and 100mm worst pain at 2 4 6 8 12 18 and 24 hr postoperatively Rescue analgesia in the form of intravenous morphine 005 mgkg was given on the patients complaint or when VAS 40 mm and repeated every 15-20 minutes until VAS 40 mm with a maximum morphine dose of 40 mg per 24 hours The duration of analgesia was calculated as the time elapsed from the end of the ICPB block procedure till VAS 40mm The total postoperative morphine consumption over 24 hours was calculated The measurement of diaphragmatic excursions was repeated as mentioned above hemi-diaphragmatic paresis was divided into three grades depending on the percentage of diaphragm movement compared with baseline to be none 75 partial paresis 25-75 and complete paresis 25
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?:
None
Is an FDA AA801 Violation?:
None