Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults

Pain, Postoperative Clinical Trial

Official title:

Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06069804
• Other study ID #: KY 2018-034-02-4
• Status: Completed
• Phase: Phase 4
• Start date: October 7, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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 triamcinolone acetonide as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity inarthroscopic knee surgery or total knee arthroplasty. However, there has not been reported about local application of triamcinolone acetonide on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (triamcinolone acetonide) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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, triamcinolone acetonide 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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• The TR group
Miscible liquid of triamcinolone acetonide and ropivacaine in this study will be peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 0.25ml triamcinolone acetonide (40mg/ml), plus 10 ml saline miscible liquids for participants who will undergo elective craniotomy. Local infiltration of the study solution was performed by the neurosurgeon after induction of general anesthesia and intubation, once all equipment and catheters had been placed, during stable and steady state anesthetic conditions before skin incision. The solution was infiltrated with a 22-gauge needle introduced into the skin at a 45° angle throughout the entire thickness of the scalp along the planned incision site and the head-holder sites, by the same neurosurgeon. The total volume of the study solution used for each patient was determined by the neurosurgeon mainly based on the length of the incision and recorded by the investigator.
• The R group
Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10 ml saline miscible liquids for participants who will undergo elective craniotomy. Local infiltration of the study solution was performed by the neurosurgeon after induction of general anesthesia and intubation, once all equipment and catheters had been placed, during stable and steady state anesthetic conditions before skin incision. The solution was infiltrated with a 22-gauge needle introduced into the skin at a 45° angle throughout the entire thickness of the scalp along the planned incision site and the head-holder sites, by the same neurosurgeon. The total volume of the study solution used for each patient was determined by the neurosurgeon mainly based on the length of the incision and recorded by the investigator.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Chaki T, Sugino S, Janicki PK, Ishioka Y, Hatakeyama Y, Hayase T, Kaneuchi-Yamashita M, Kohri N, Yamakage M. Efficacy and Safety of a Lidocaine and Ropivacaine Mixture for Scalp Nerve Block and Local Infiltration Anesthesia in Patients Undergoing Awake Craniotomy. J Neurosurg Anesthesiol. 2016 Jan;28(1):1-5. doi: 10.1097/ANA.0000000000000149. — View Citation

Dunn LK, Naik BI, Nemergut EC, Durieux ME. Post-Craniotomy Pain Management: Beyond Opioids. Curr Neurol Neurosci Rep. 2016 Oct;16(10):93. doi: 10.1007/s11910-016-0693-y. — View Citation

Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210. — View Citation

Penning LI, de Bie RA, Walenkamp GH. Subacromial triamcinolone acetonide, hyaluronic acid and saline injections for shoulder pain an RCT investigating the effectiveness in the first days. BMC Musculoskelet Disord. 2014 Oct 23;15:352. doi: 10.1186/1471-2474-15-352. — View Citation

Sean VW, Chin PL, Chia SL, Yang KY, Lo NN, Yeo SJ. Single-dose periarticular steroid infiltration for pain management in total knee arthroplasty: a prospective, double-blind, randomised controlled trial. Singapore Med J. 2011 Jan;52(1):19-23. — View Citation

Wang JJ, Ho ST, Lee SC, Tang JJ, Liaw WJ. Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. Anesth Analg. 1998 Nov;87(5):1113-6. doi: 10.1097/00000539-199811000-00024. — View Citation

Wesley CK, Teo LH, Xu T, Unger RH, Unger WP. The influence of peri-incisional triamcinolone acetonide injection on wound edge apposition. J Dermatolog Treat. 2014 Aug;25(4):345-9. doi: 10.3109/09546634.2012.755253. Epub 2013 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 48 hours after the operation
Secondary	The first time to press the patient-controlled analgesia button	The first time that the participants press the patient-controlled analgesia button.	Within 48 hours after the operation
Secondary	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.	Within 48 hours postoperatively
Secondary	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).	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month,
Secondary	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.	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Secondary	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.	Within 48 hours after the operation
Secondary	The total consumption of opioids during the operation	The total consumption of opioids during the operation	During procedure
Secondary	The length of stay	The duration of hospitalization after the operation	Approximately 2 weeks after the surgery
Secondary	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	At 1 month after surgery