Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04073069

Collaborator

(none)

Enrollment

Location

Arms

17.4

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Post-Craniotomy Headache	Drug: The DR group Drug: The R group	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Pre-emptive Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults

Actual Study Start Date :

Sep 3, 2019

Actual Primary Completion Date :

Aug 15, 2020

Actual Study Completion Date :

Feb 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The DR group Participates received peri-incisional scalp infiltration with 15ml ropivacaine 1% wt/vol, 0.5ml diprospan, plus 14.5ml saline;	Drug: The DR group 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.
Active Comparator: The R group Participates received peri-incisional scalp infiltration with 15ml ropivacaine 1% wt/vol, plus 15ml saline;	Drug: The R group 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.

Arm

Intervention/Treatment

Experimental: The DR group

Participates received peri-incisional scalp infiltration with 15ml ropivacaine 1% wt/vol, 0.5ml diprospan, plus 14.5ml saline;

Drug: The DR group

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.

Active Comparator: The R group

Participates received peri-incisional scalp infiltration with 15ml ropivacaine 1% wt/vol, plus 15ml saline;

Drug: The R group

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.

Outcome Measures

Primary Outcome Measures

Cumulative sufentanil consumption within 48 hours postoperatively [Within 48 hours after the operation]
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.

Secondary Outcome Measures

The number of participants who have no sufentanil consumption [Within 48 hours after the operation]
The number of participants who have not pushed the button of patient-controlled analgesia pump.
The first time to press the patient-controlled analgesia button [Within 48 hours after the operation]
The first time that the participants press the patient-controlled analgesia button.
The total times that participants press patient-controlled analgesia button [Within 48 hours postoperatively]
The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.
Numerical rating scale (NRS) [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]
Pain will be assessed after surgery by numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Postoperative nausea and vomiting [At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery]
Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Ramsay Sedation Scale (RSS) [At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery]
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.
Respiratory depression [Within 48 hours after the operation]
Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.
The times of emergency reducing blood pressure after the operation [Within 48 hours 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.
Patient satisfactory scale (PSS) [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]
0 for unsatisfactory, and 10 for very satisfied
The total consumption of opioids during the operation [During procedure]
The total consumption of opioids during the operation
The length of stay [Approximately 2 weeks after the operation]
The duration of hospitalization after the operation
The World Health Organization Quality of Life (WHOQOL)-BREF [At 1 month, 3 months and 6 months after surgery]
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.
Wound Healing Score [At 1 month after surgery]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
American Society of Anesthesiologists (ASA) physical status of I , II or III;
Participates with an anticipated fully recovery within 2 hours postoperatively.

Exclusion Criteria:

History of craniotomy;
Expected delayed extubation or no plan to extubate;
Participants who cannot use a patient-controlled analgesia (PCA) device;
Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
Extreme body mass index (BMI) (< 15 or > 35);
Allergy to opioids, diprospan or ropivacaine;
History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
Pregnant or at breastfeeding;
Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
Preoperative Glasgow Coma Scale< 15;
Suspicion of intracranial hypertension;
Peri-incisional infection;
Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.