Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636864
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Effect of Intrathecal Morphine on Quality of Recovery After Laparoscopic Colorectal Cancer Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Intrathecal Morphine on Quality of Recovery After Laparoscopic Colorectal Cancer Surgery
Status:
NOT_YET_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:
Colorectal cancer is the second most common tumor in women and the third most common tumor in men accounting for approximately 10 of tumors diagnosed and tumor-related deaths worldwide each year Laparoscopic resection has become the standard of colorectal cancer surgery and its main advantages are to shorten the length of hospital stay reduce postoperative pain and accelerate patient recovery However it has been reported that about 49 of patients undergoing laparoscopic colorectal cancer surgery still have moderate to severe postoperative pain The insertion of abdominal drainage tube will increase the degree of postoperative pain especially when patients take deep breaths exercise or cough which will increase the demand for postoperative opioids and reduce the quality of postoperative recovery How to further reduce the postoperative pain of patients reduce the dosage of opioids shorten the length of hospital stay promote the rapid recovery of patients and improve patient satisfaction are our concerns Intrathecal morphine can provide a good analgesic effect on visceral pain At present intrathecal morphine has become a new method of postoperative analgesia which is used in thoracic abdominal and obstetrics and gynecology operations The objective of this study was to investigate the effect of intrathecal morphine on the quality of recovery after laparoscopic colon cancer surgery
Detailed Description:
Colorectal cancer is the second most common tumor in women and the third most common tumor in men accounting for approximately 10 of tumors diagnosed and tumor-related deaths worldwide each year Laparoscopic resection has become the standard of colorectal cancer surgery and its main advantages are to shorten the length of hospital stay reduce postoperative pain and accelerate patient recovery However it has been reported that about 49 of patients undergoing laparoscopic colorectal cancer surgery still have moderate to severe postoperative pain The insertion of abdominal drainage tube will increase the degree of postoperative pain especially when patients take deep breaths exercise or cough which will increase the demand for postoperative opioids and reduce the quality of postoperative recovery How to further reduce the postoperative pain of patients reduce the dosage of opioids shorten the length of hospital stay promote the rapid recovery of patients and improve patient satisfaction are our concerns
The anesthesia scheme was endotracheal intubation general anesthesia combined with bupivacaine liposome plane block of transverse abdominal muscle experimental group combined with intrathecal morphine control group injected with intrathecal saline Heart rate electrocardiogram pulse oxygen saturation noninvasive blood pressure and end-expiratory partial carbon dioxide pressure ETCO2 were routinely monitored after entry Before anesthesia induction the experimental group received lumbar morphine L34 Based on the literature and our previous clinical application the intrathecal morphine was 250ug for males and 200ug for females Control group received intrathecal injection of normal saline General anesthesia was induced by intravenous injection of dexmedetomidine 05ugkg cyclopofol 04mgkg remifentanil TCI4ngml and rocuronium 06mgkg followed by tracheal intubation Bupivacaine liposome plane block of transverse abdominal muscle was performed in both groups bupivacaine liposome injection 20ml 266mg was diluted with 09 sodium chloride solution from 20ml to 40ml and 10ml diluent solution was injected into the left and right abdominal subcostoal approach and lateral approach under ultrasound guidance Anesthesia was maintained with 1-13MAC desflurane remifentanil sufentanil cis-atracurium and vasoactive agents as needed Intraoperative opioid dosage was recorded Patients in both groups received intravenous controlled analgesia 150mg morphine with 09 sodium chloride solution to 150ml intravenous analgesia pump The background dose is 0mlh the single patient-controlled analgesia dose is 1ml and the locking time is 6 minutes to manage fulminant pain When adverse events such as hypotension occur appropriate accelerated fluid rehydration is given while makingWith vasoactive drugs the nurse who did not participate in the study was asked to reduce the parameters of the intravenous analgesic pump to 12 of the original and if the symptoms persisted the analgesic pump was turned off and the study was terminated The main outcome was QoR15 score 24 hours after operation
The anesthesia scheme was endotracheal intubation general anesthesia combined with bupivacaine liposome plane block of transverse abdominal muscle experimental group combined with intrathecal morphine control group injected with intrathecal saline Heart rate electrocardiogram pulse oxygen saturation noninvasive blood pressure and end-expiratory partial carbon dioxide pressure ETCO2 were routinely monitored after entry Before anesthesia induction the experimental group received lumbar morphine L34 Based on the literature and our previous clinical application the intrathecal morphine was 250ug for males and 200ug for females Control group received intrathecal injection of normal saline General anesthesia was induced by intravenous injection of dexmedetomidine 05ugkg cyclopofol 04mgkg remifentanil TCI4ngml and rocuronium 06mgkg followed by tracheal intubation Bupivacaine liposome plane block of transverse abdominal muscle was performed in both groups bupivacaine liposome injection 20ml 266mg was diluted with 09 sodium chloride solution from 20ml to 40ml and 10ml diluent solution was injected into the left and right abdominal subcostoal approach and lateral approach under ultrasound guidance Anesthesia was maintained with 1-13MAC desflurane remifentanil sufentanil cis-atracurium and vasoactive agents as needed Intraoperative opioid dosage was recorded Patients in both groups received intravenous controlled analgesia 150mg morphine with 09 sodium chloride solution to 150ml intravenous analgesia pump The background dose is 0mlh the single patient-controlled analgesia dose is 1ml and the locking time is 6 minutes to manage fulminant pain When adverse events such as hypotension occur appropriate accelerated fluid rehydration is given while makingWith vasoactive drugs the nurse who did not participate in the study was asked to reduce the parameters of the intravenous analgesic pump to 12 of the original and if the symptoms persisted the analgesic pump was turned off and the study was terminated The main outcome was QoR15 score 24 hours after operation
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