Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications, such as arterial hypertension, intracranial hemorrhage, prolonged hospital stay, and mortality. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as diprospan as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity in knee osteoarthritis or in total knee arthroplasty. However, there has not been reported about local application of diprospan on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
96
Miscible liquid of diprospan and ropivacaine in this study will be peri-incisional scalp infiltration with 0.5 ml diprospan, 15 ml 1% ropivacaine and 14.5 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 15 ml 1% ropivacaine and 15 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Cumulative sufentanil consumption within 48 hours postoperatively
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.
Time frame: Within 48 hours after the operation
The number of participants who have no sufentanil consumption
The number of participants who have not pushed the button of patient-controlled analgesia pump.
Time frame: Within 48 hours after the operation
The first time to press the patient-controlled analgesia button
The first time that the participants press the patient-controlled analgesia button.
Time frame: Within 48 hours after the operation
The total times that participants press patient-controlled analgesia button
The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.
Time frame: Within 48 hours postoperatively
Numerical rating scale (NRS)
Pain will be assessed after surgery by numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery
Postoperative nausea and vomiting
Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Ramsay Sedation Scale (RSS)
Ramsey 1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Respiratory depression
Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.
Time frame: Within 48 hours after the operation
The times of emergency reducing blood pressure after the operation
The criteria for treatment is determined by the participant's surgeon in charge.The times of emergency reducing blood pressure will be recording by the investigator.
Time frame: Within 48 hours after the operation
Patient satisfactory scale (PSS)
0 for unsatisfactory, and 10 for very satisfied
Time frame: t 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery
The total consumption of opioids during the operation
The total consumption of opioids during the operation
Time frame: During procedure
The length of stay
The duration of hospitalization after the operation
Time frame: Approximately 2 weeks after the operation
The World Health Organization Quality of Life (WHOQOL)-BREF
Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale.
Time frame: At 1 month, 3 months and 6 months after surgery
Wound Healing Score
Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: \>3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis \>3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: \>3-6 cm not regrowing; 4: \>6 cm not regrowing; not applicable
Time frame: At 1 month after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.