Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652581
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Effectiveness Of Modified-Thoracoabdominal Nerve Block Perichondrial Approach M-TAPA In Laparoscopic Cholecystectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness Of Modified-Thoracoabdominal Nerve Block Perichondrial Approach M-TAPA Post-Operative Analgesia Compared To Intravenous Opioids In Laparoscopic Cholecystectomy Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Goal of this clinical trial is to determine the advantages of using Peripheral Nerve Block by injecting drugs under the skin on both sides of the abdomen in the upper abdominal area in patients undergoing laparoscopic Cholecystectomy Study participants will be divided into 2 groups namely group P1 receiving Modified Thoracoabdominal Perichondrial Approach M-TAPA block anesthesia after laparoscopic cholecystectomy and group P2 only receiving intravenous opioids postoperatively Peripheral nerve blocks on both sides of the upper abdomen are expected to be able to prolong the duration of pain relief reduce the pain scale and the total dose of pain medication needed postoperatively The injection of this peripheral nerve block drug will be carried out by an anesthesiologist Researchers will continue to anticipate the occurrence of side effects that can occur with strict monitoring and emergency care standards This study will last up to 24 hours after surgery
The main question it aims to answer is
To prove that the amount of postoperative intravenous opioid consumption with M-TAPA block is lower than the control group
The main question it aims to answer is
To prove that the amount of postoperative intravenous opioid consumption with M-TAPA block is lower than the control group
Detailed Description:
A Treatment of patients in P1 and P2 before entering the operating room
1 Every patient who meets the eligibility criteria will be asked for consent to become a subject of this study Proof of consent is the signing of a letter of willingness to become a subject of the study by the informant the consent giver and one witness Quality of Recovery using QoR 40 form will evaluate before surgery and 24 hours after surgery
2 Patients have been fasted for 8 hours from solid food before surgery clear water up to 2 hours before surgery The infusion is installed 2 hours before the patient is sent to the operating room using an 18G intravenous catheter with Ringer lactate fluid at a rate of administration according to the patient weight 10 mlkghour
B Treatment of patients in the operating room P1 and P2
1 General anesthesia was performed in both groups
2 General anesthesia begins with preoxygenation for 3-5 minutes with 100 O2
3 Continued induction using intravenous propofol 2 mgkgBW and intravenous fentanyl 2 mcgkgBW
4 After the patient is induced continue by giving the muscle relaxant atracurium 05 mgkgBW intravenously
5 After three minutes laryngoscopy and intubation are performed using an endotracheal tube ETT with a size according to the patient needs
6 Maintain anesthesia with oxygen and compressed air with a ratio of 1 liter 1 liter and sevoflurane
7 All patients were performed with the same laparoscopic cholecystectomy procedure 4-port technique umbilical port 5mm infraxiphoidal 15-20 mm lateral intersection of the umbilicus and axillary line 5 mm and symmetrical assistant port 5 mm With a pneumoperitoneum pressure of 10-12 mmHg
8 Continue with the operation until completion One hour before the surgery is completed the patient is given anti-vomiting prophylaxis ondansetron 01 mgkgBW intravenously
Group P1
1 Continue with preparation for the block procedure on the patient
2 After the necessary tools and materials are ready the Anesthesiologist who will perform the block washes his hands sterilely uses a sterile gown and gloves
3 Then the area of action is disinfected with the sequence of 70 alcohol betadine 70 alcohol then a sterile hole drape is installed
4 Identification of the place to perform the block is carried out namely between the midclavicular line and the anterior axillary The injection identification guide uses ultrasound
5 The ultrasound machine uses a linear probe placed on the chondrium with a sagittal cut at Costa 10 identifying the external oblique muscle internal oblique transversus abdominis costal cartilage Stimuplex 22Gx50mm is injected using the in-plane technique The tip of the needle is placed under the chondrium
6 Before injecting local anesthetic drugs negative aspiration exclusion of intravascular injection and hydrodissection using 09 NaCl as much as 1 - 2 ml are performed to further ensure the area of the needle tip Local anesthetic bupivacaine 025 as much as 20 ml is then injected into the field
7 After the needle injection is removed a block is performed with the same procedure on the opposite side
8 Evaluation of the success of the M-TAPA block is carried out and monitor the occurrence of blood vessel puncture hypotension desaturation and bradycardia
9 If hypotension occurs if the pulse rate is 60 x minute bolus phenylephrine 50 mcg if the pulse rate is 60 x minute bolus ephedrine 4 mg IV until the mean arterial pressure MAP returns to the baseline value If there is no improvement it can be repeated at 5-minute intervals If hypotension persists norepinephrine is given by titration at a dose of 01 mcg kgBW minute
10 If bradycardia occurs with unstable hemodynamics the patient is given an intravenous injection of atropine sulfate 05 mg
11 If desaturation occurs perform a physical examination for signs of pneumothorax lung sounds disappear hyperresonant percussion if tension pneumothorax occurs perform needle decompression then consult a colleague in cardiovascular thoracic surgery BTKV for further management
Group P2 No block is performed after the operation is completed extubation preparation is carried out immediately
Procedures P1 and P2 after surgery
1 After the block is completed the patient is given an injection of neostigmine and atropine sulfate to antagonize the remaining atracurium drug still in the patients body The patient is extubated after the patients breathing is adequate and the airway is clear
2 The patient is observed in the recovery room for 2 hours and transferred to the room if there are no complaints and the Aldrete score is 9 The pain scale using Numeric Rating Scale is evaluated for the first 0 hours in the recovery room Observations in the recovery room include patient complaints blood pressure pulse ECG respiratory rate and peripheral saturation are carried out every 15 minutes until the patient is transferred to the room The observation results are recorded on the patients anesthesia record sheet
3 After the patient moves to the room the acute pain service APS team will evaluate the pain scale with Numeric Rating Scale NRS at 2 12 24 hours postoperatively and the total opioid consumption data on the PCA machine will be recorded
4 Quality of Recovery will evaluate again 24 hours Post Operative
1 Every patient who meets the eligibility criteria will be asked for consent to become a subject of this study Proof of consent is the signing of a letter of willingness to become a subject of the study by the informant the consent giver and one witness Quality of Recovery using QoR 40 form will evaluate before surgery and 24 hours after surgery
2 Patients have been fasted for 8 hours from solid food before surgery clear water up to 2 hours before surgery The infusion is installed 2 hours before the patient is sent to the operating room using an 18G intravenous catheter with Ringer lactate fluid at a rate of administration according to the patient weight 10 mlkghour
B Treatment of patients in the operating room P1 and P2
1 General anesthesia was performed in both groups
2 General anesthesia begins with preoxygenation for 3-5 minutes with 100 O2
3 Continued induction using intravenous propofol 2 mgkgBW and intravenous fentanyl 2 mcgkgBW
4 After the patient is induced continue by giving the muscle relaxant atracurium 05 mgkgBW intravenously
5 After three minutes laryngoscopy and intubation are performed using an endotracheal tube ETT with a size according to the patient needs
6 Maintain anesthesia with oxygen and compressed air with a ratio of 1 liter 1 liter and sevoflurane
7 All patients were performed with the same laparoscopic cholecystectomy procedure 4-port technique umbilical port 5mm infraxiphoidal 15-20 mm lateral intersection of the umbilicus and axillary line 5 mm and symmetrical assistant port 5 mm With a pneumoperitoneum pressure of 10-12 mmHg
8 Continue with the operation until completion One hour before the surgery is completed the patient is given anti-vomiting prophylaxis ondansetron 01 mgkgBW intravenously
Group P1
1 Continue with preparation for the block procedure on the patient
2 After the necessary tools and materials are ready the Anesthesiologist who will perform the block washes his hands sterilely uses a sterile gown and gloves
3 Then the area of action is disinfected with the sequence of 70 alcohol betadine 70 alcohol then a sterile hole drape is installed
4 Identification of the place to perform the block is carried out namely between the midclavicular line and the anterior axillary The injection identification guide uses ultrasound
5 The ultrasound machine uses a linear probe placed on the chondrium with a sagittal cut at Costa 10 identifying the external oblique muscle internal oblique transversus abdominis costal cartilage Stimuplex 22Gx50mm is injected using the in-plane technique The tip of the needle is placed under the chondrium
6 Before injecting local anesthetic drugs negative aspiration exclusion of intravascular injection and hydrodissection using 09 NaCl as much as 1 - 2 ml are performed to further ensure the area of the needle tip Local anesthetic bupivacaine 025 as much as 20 ml is then injected into the field
7 After the needle injection is removed a block is performed with the same procedure on the opposite side
8 Evaluation of the success of the M-TAPA block is carried out and monitor the occurrence of blood vessel puncture hypotension desaturation and bradycardia
9 If hypotension occurs if the pulse rate is 60 x minute bolus phenylephrine 50 mcg if the pulse rate is 60 x minute bolus ephedrine 4 mg IV until the mean arterial pressure MAP returns to the baseline value If there is no improvement it can be repeated at 5-minute intervals If hypotension persists norepinephrine is given by titration at a dose of 01 mcg kgBW minute
10 If bradycardia occurs with unstable hemodynamics the patient is given an intravenous injection of atropine sulfate 05 mg
11 If desaturation occurs perform a physical examination for signs of pneumothorax lung sounds disappear hyperresonant percussion if tension pneumothorax occurs perform needle decompression then consult a colleague in cardiovascular thoracic surgery BTKV for further management
Group P2 No block is performed after the operation is completed extubation preparation is carried out immediately
Procedures P1 and P2 after surgery
1 After the block is completed the patient is given an injection of neostigmine and atropine sulfate to antagonize the remaining atracurium drug still in the patients body The patient is extubated after the patients breathing is adequate and the airway is clear
2 The patient is observed in the recovery room for 2 hours and transferred to the room if there are no complaints and the Aldrete score is 9 The pain scale using Numeric Rating Scale is evaluated for the first 0 hours in the recovery room Observations in the recovery room include patient complaints blood pressure pulse ECG respiratory rate and peripheral saturation are carried out every 15 minutes until the patient is transferred to the room The observation results are recorded on the patients anesthesia record sheet
3 After the patient moves to the room the acute pain service APS team will evaluate the pain scale with Numeric Rating Scale NRS at 2 12 24 hours postoperatively and the total opioid consumption data on the PCA machine will be recorded
4 Quality of Recovery will evaluate again 24 hours Post Operative
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None