Trial Title:
Effect of Intrathecal Morphine on Quality of Recovery After Laparoscopic Colorectal Cancer Surgery
NCT ID:
NCT06636864
Condition:
Laparoscopic Colorectal Cancer Surgery
Conditions: Official terms:
Colorectal Neoplasms
Morphine
Conditions: Keywords:
Laparoscopic colorectal cancer surgery
QoR-15
Intrathecal morphine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Intrathecal morphine
Description:
The patient was asked to lie on the side, the needle insertion point was located under
the guidance of color ultrasound, and after local anesthesia, the needle was inserted
into the subarachnoid space at the puncture point and morphine was injected.
Arm group label:
Intrathecal morphine group
Intervention type:
Procedure
Intervention name:
Intrathecal saline injection
Description:
After the patient was asked to lie on his side, the injection point was determined under
the guidance of color ultrasound. After local anesthesia, the needle was injected into
the subarachnoid space and then normal saline was injected.
Arm group label:
Normal saline group
Intervention type:
Procedure
Intervention name:
TAPB
Description:
The patient was in a supine position. The rectus muscle was confirmed to be warping under
the guidance of color photography, and the needle was injected with bupivacaine liposomes
Arm group label:
Intrathecal morphine group
Arm group label:
Normal saline group
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
(L3/4). 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 (0.5ug/kg), cyclopofol (0.4mg/kg), remifentanil (TCI4ng/ml) and
rocuronium (0.6mg/kg), 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 0.9% 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
1-1.3MAC 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 0.9% sodium chloride solution to
150ml intravenous analgesia pump. The background dose is 0ml/h, 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 1/2 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Laparoscopic colorectal cancer surgery under tracheal intubation and general
anesthesia is intended
- Agreed to use intravaginal morphine injection and bupivacaine liposomal plane block
of transversal muscle after surgery
- ASA Grade I - III
- Over 18 years of age
Exclusion Criteria:
- Preoperative accident or subjective refusal of surgery
- Nervous system dysfunction
- Contraindications to intraspinal anesthesia
- Preoperative opioid use history
- Patients with abnormal preoperative pain and pain score (NRS) >3
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
GuangZhou
Country:
China
Contact:
Last name:
Renchun Lai
Phone:
+8613660012343
Email:
lairch@sysucc.org.cn
Start date:
October 15, 2024
Completion date:
October 30, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06636864
