Ignite Creation Date:
2024-05-06 @ 12:19 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03730714
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2018-11-02
Brief Title:
Surgicel and Analgesic Reservoir
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Surgicel a Probable Analgesic Reservoir for Post-laparoscopic Cholecystectomy Pain Management Randomized Controlled Double-blind Trial
Status:
COMPLETED
Status Verified Date:
2020-08
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:
Laparoscopic cholecystectomy LC is a widespread surgical procedure with superior outcomes in terms of the incurred postoperative pain recovery time cosmetic and morbidity issues Although it is associated with less postoperative pain compared to open cholecystectomy but patients still experience significant pain Pain after LC is categorized into three types referred pain to the right shoulder due to diaphragmatic stretching during gas insufflation visceral pain due to dissection and injury at the hepatic fossa during gall bladder removal and somatic pain due to tissue injury at the port sites Since the discovery of LC in 1987 by a French surgeon Phillipe Mouret it became the gold standard for surgical excision of the gallbladder Local anesthetics LA has been tried for analgesia after LC in variable techniques and concentrations It was proved to be a safe and valid method for reducing pain after LC instilled intraperitoneal and infiltrated at the port sites
Surgicel is an absorbable gelatin sponge that is non-toxic non-allergenic non-immunogenic and non-pyrogenic It is gamma-sterilized and provided with double packing The sponge is easily cut to fit the surgical cavity It may be applied dry to the wound It absorbs 40 times its weight of whole blood or 50 times of water and adheres easily to the bleeding site It forms a stable adherent coagulum When implanted in vivo it is completely absorbed within 3-5 weeks The rationale for using this sponge as interposition material is to act as a carrier for the analgesic drugs and allow for its local sustained release and for local hemostasis Bupivacaine will be used as the main local anesthetic medication in the study It provides variable pain relief when either used to irrigate intraperitoneal space as a sole analgesic or combined with opioids Lidocaine 2 will be mixed with bupivacaine to expedite the onset of analgesia Epinephrine will be used as 5 microgramml of the total mixture of used fluids in order to prolong the time of action of the block
Surgicel is an absorbable gelatin sponge that is non-toxic non-allergenic non-immunogenic and non-pyrogenic It is gamma-sterilized and provided with double packing The sponge is easily cut to fit the surgical cavity It may be applied dry to the wound It absorbs 40 times its weight of whole blood or 50 times of water and adheres easily to the bleeding site It forms a stable adherent coagulum When implanted in vivo it is completely absorbed within 3-5 weeks The rationale for using this sponge as interposition material is to act as a carrier for the analgesic drugs and allow for its local sustained release and for local hemostasis Bupivacaine will be used as the main local anesthetic medication in the study It provides variable pain relief when either used to irrigate intraperitoneal space as a sole analgesic or combined with opioids Lidocaine 2 will be mixed with bupivacaine to expedite the onset of analgesia Epinephrine will be used as 5 microgramml of the total mixture of used fluids in order to prolong the time of action of the block
Detailed Description:
Eligibility and type of the study This prospective randomized placebo-controlled double-blind study will be conducted after approval from the Institutional Ethics Committee and obtaining a written informed consent from patients undergoing elective laparoscopic cholecystectomy under general anesthesia
Sample Size Sample size was calculated according to the previously conducted similar studies in the same field Based on a pilot study where the incidence of postoperative pain after laparoscopies was found to be more than 70 and intervention that can cause 50 reduction in this incidence was required With a power of 90 and type I error of 5 26 patients were required to be in each group but to avoid possible patients dropouts the number of patients in each group is increased to 30 total of 90 patients
Drugs Coding and Randomization Patients will be randomly allocated into three equal groups 30 patients each using a computer-generated table of random numbers in order to allocate the patients into the three study groups Neither the anesthesia provider nor the participant will be aware of the study group or the drug used One anesthesiologist not included in the procedure observation or in the data collection will prepare the study drugs Two surgeons with average similar level of experience in the field will operate upon patients sequentially without a specific order All patients will have full explanation about the anesthetic and analgesic techniques they will have before signing their consent
Anesthesia Technique
Before the day of the surgery patients will visit the outpatient clinic for medical assessment and description of the study protocol after securing their eligibility to participate in the study Laboratory investigations will be performed and patients will sign the consent All patients will receive the standard general anesthesia technique followed in the hospital preoperative 8 hours of NPO premedication with proton pump inhibitor and antiemetic
At operative theatre patients will be connected to five standard monitoring measures electrocardiography ECG non-invasive blood pressure NIBP pulse oxymetry SpO2 core body temperature and end-tidal carbon dioxide An intravenous cannula 18G will be inserted in the dorsum of the non-dominant hand and normal saline 09 IV fluids will be infused at a rate of 6-8 mlkgh throughout the surgery
After 3 minutes of pre-oxygenation with 100 O2 via the appropriate size face mask general anesthesia will be induced with 1 µgkg of fentanyl 2-3 mgkg of propofol cisatracurium 015 mgkg Patients will be intubated with an appropriate size cuffed endotracheal tube under direct laryngoscopy after complete muscular relaxation Anesthesia will be maintained with sevoflurane at 2-3 MAC and cisatracurium 003 mgkg Mechanical ventilation will be maintained and respiratory parameters will be adjusted to keep the end-tidal CO2 at 35-45 mmHg At the end of the surgery residual neuromuscular blockade will be pharmacologically reversed using neostigmine 004 mgkg and atropine 002 mgkg and trachea will be extubated once the patient is showing clinical signs of clearance from neuromuscular blockade and TOF ratio of 09 is achieved In order to control postoperative pain the patients will receive IV paracetamol 1 gm Perfalgan Paracetamol 1000 mg UPSA laboratories France
The Study Technique
After the end of the operative procedure the patient will have a cut piece of surgicel folded passed through the big port and intersected dry to cover the gallbladder bed area of the hepatic fossa The prepared study mixture of medicine will be 32 ml
Instilled to soak the surgicel at the hepatic fossa 10 ml
Splash the undersurface of the right copula of the diaphragm 10 ml
Instilled to soak small pieces of surgicel intersected in the port areas 12 ml
Groups
1 First study group LAM will receive local anesthesia Bupivacaine 05 20 ml no more than 2 mgkg plus lidocaine 2 10 ml no more than 3 mgkg mixed together plus epinephrine 5 mcgml max 150 mcg combined with morphine 01 mgkg max10 mg instilled into the assigned areas according to the technique
2 Second study group LAMG will receive the same mixture in LAM-group to soak the surgicel according to the previous planned technique
3 Control group CG will receive normal saline 09 to soak the surgicel according to the planned technique
Statistical Analysis
Data will be collected and analyzed by computer program SPSS SPSS Inc Chicago Illinos USA version 23 Data will be expressed as means standard deviations ranges numbers and percentages The analysis of variance and Chi-square test will be used to assess that the study groups are matched in terms of demographic data Chi-Square or Fisher exact test will be used to determine significance for categorical variables T-test or Mann-Whitney test if necessary will be used to determine significance for numeric variables Kruskal-Wallis test followed by the Wilcoxon matched pairs rank test will be used specifically to compare VAS and VRS P value 005 will be considered statistically significant
Sample Size Sample size was calculated according to the previously conducted similar studies in the same field Based on a pilot study where the incidence of postoperative pain after laparoscopies was found to be more than 70 and intervention that can cause 50 reduction in this incidence was required With a power of 90 and type I error of 5 26 patients were required to be in each group but to avoid possible patients dropouts the number of patients in each group is increased to 30 total of 90 patients
Drugs Coding and Randomization Patients will be randomly allocated into three equal groups 30 patients each using a computer-generated table of random numbers in order to allocate the patients into the three study groups Neither the anesthesia provider nor the participant will be aware of the study group or the drug used One anesthesiologist not included in the procedure observation or in the data collection will prepare the study drugs Two surgeons with average similar level of experience in the field will operate upon patients sequentially without a specific order All patients will have full explanation about the anesthetic and analgesic techniques they will have before signing their consent
Anesthesia Technique
Before the day of the surgery patients will visit the outpatient clinic for medical assessment and description of the study protocol after securing their eligibility to participate in the study Laboratory investigations will be performed and patients will sign the consent All patients will receive the standard general anesthesia technique followed in the hospital preoperative 8 hours of NPO premedication with proton pump inhibitor and antiemetic
At operative theatre patients will be connected to five standard monitoring measures electrocardiography ECG non-invasive blood pressure NIBP pulse oxymetry SpO2 core body temperature and end-tidal carbon dioxide An intravenous cannula 18G will be inserted in the dorsum of the non-dominant hand and normal saline 09 IV fluids will be infused at a rate of 6-8 mlkgh throughout the surgery
After 3 minutes of pre-oxygenation with 100 O2 via the appropriate size face mask general anesthesia will be induced with 1 µgkg of fentanyl 2-3 mgkg of propofol cisatracurium 015 mgkg Patients will be intubated with an appropriate size cuffed endotracheal tube under direct laryngoscopy after complete muscular relaxation Anesthesia will be maintained with sevoflurane at 2-3 MAC and cisatracurium 003 mgkg Mechanical ventilation will be maintained and respiratory parameters will be adjusted to keep the end-tidal CO2 at 35-45 mmHg At the end of the surgery residual neuromuscular blockade will be pharmacologically reversed using neostigmine 004 mgkg and atropine 002 mgkg and trachea will be extubated once the patient is showing clinical signs of clearance from neuromuscular blockade and TOF ratio of 09 is achieved In order to control postoperative pain the patients will receive IV paracetamol 1 gm Perfalgan Paracetamol 1000 mg UPSA laboratories France
The Study Technique
After the end of the operative procedure the patient will have a cut piece of surgicel folded passed through the big port and intersected dry to cover the gallbladder bed area of the hepatic fossa The prepared study mixture of medicine will be 32 ml
Instilled to soak the surgicel at the hepatic fossa 10 ml
Splash the undersurface of the right copula of the diaphragm 10 ml
Instilled to soak small pieces of surgicel intersected in the port areas 12 ml
Groups
1 First study group LAM will receive local anesthesia Bupivacaine 05 20 ml no more than 2 mgkg plus lidocaine 2 10 ml no more than 3 mgkg mixed together plus epinephrine 5 mcgml max 150 mcg combined with morphine 01 mgkg max10 mg instilled into the assigned areas according to the technique
2 Second study group LAMG will receive the same mixture in LAM-group to soak the surgicel according to the previous planned technique
3 Control group CG will receive normal saline 09 to soak the surgicel according to the planned technique
Statistical Analysis
Data will be collected and analyzed by computer program SPSS SPSS Inc Chicago Illinos USA version 23 Data will be expressed as means standard deviations ranges numbers and percentages The analysis of variance and Chi-square test will be used to assess that the study groups are matched in terms of demographic data Chi-Square or Fisher exact test will be used to determine significance for categorical variables T-test or Mann-Whitney test if necessary will be used to determine significance for numeric variables Kruskal-Wallis test followed by the Wilcoxon matched pairs rank test will be used specifically to compare VAS and VRS P value 005 will be considered statistically significant
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