Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy

Pain, Postoperative Clinical Trial

Official title:

Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine vs. Ropivacaine for Relief of Postoperative Pain After Craniotomy in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618264
• Other study ID #: KY 2018-034-02-1
• Status: Completed
• Phase: Phase 4
• Start date: April 4, 2019
• Est. completion date: February 13, 2020

Study information

• Verified date: February 2020
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. As a result, adequate pain control is essential for patients' prognosis and their postoperative life quality. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, 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. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Thus, Investigators suppose that pre-emptive scalp infiltration with steroid (dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 13, 2020
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for elective craniotomy for resection of a supratentorial tumour under general anaesthesia;

• American Society of Anesthesiologists (ASA) physical status of I or II;

• Participates required to fix their head in a head clamp intraoperatively;

• 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, dexamethasone 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

• Headache
• Pain, Postoperative
• Post-Craniotomy Headache

Intervention

Drug:
• Miscible liquid of dexamethasone and ropivacaine
Intervention in this study will be peri-incisional scalp infiltration with dexamethasone, ropivacaine and normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter 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.
• Ropivacaine
Intervention in this study will be peri-incisional scalp infiltration with ropivacaine for participants who will undergo elective craniotomy. The local infiltration solution containing 5mg ropivacaine per milliliter 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

Akcil EF, Dilmen OK, Vehid H, Ibisoglu LS, Tunali Y. Which one is more effective for analgesia in infratentorial craniotomy? The scalp block or local anesthetic infiltration. Clin Neurol Neurosurg. 2017 Mar;154:98-103. doi: 10.1016/j.clineuro.2017.01.018. Epub 2017 Jan 30. — View Citation

Chowdhury T, Garg R, Sheshadri V, Venkatraghavan L, Bergese SD, Cappellani RB, Schaller B. Perioperative Factors Contributing the Post-Craniotomy Pain: A Synthesis of Concepts. Front Med (Lausanne). 2017 Mar 1;4:23. doi: 10.3389/fmed.2017.00023. eCollection 2017. Review. — 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. Review. — View Citation

Misra S, Koshy T, Suneel PR. Oral clonidine attenuates the fall in mean arterial pressure due to scalp infiltration with epinephrine-lidocaine solution in patients undergoing craniotomy: a prospective, randomized, double-blind, and placebo controlled trial. J Neurosurg Anesthesiol. 2009 Oct;21(4):297-301. doi: 10.1097/ANA.0b013e3181ac7a31. — View Citation

Mordhorst C, Latz B, Kerz T, Wisser G, Schmidt A, Schneider A, Jahn-Eimermacher A, Werner C, Engelhard K. Prospective assessment of postoperative pain after craniotomy. J Neurosurg Anesthesiol. 2010 Jul;22(3):202-6. doi: 10.1097/ANA.0b013e3181df0600. — View Citation

Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR. Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689. — View Citation

Rocha-Filho PA. Post-craniotomy headache: a clinical view with a focus on the persistent form. Headache. 2015 May;55(5):733-8. doi: 10.1111/head.12563. Epub 2015 Apr 22. Review. — View Citation

Tsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23. Review. — View Citation

Vallapu S, Panda NB, Samagh N, Bharti N. Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthetic Agent in Scalp Block and Scalp Infiltration to Control Postcraniotomy Pain: A Double-Blind Randomized Trial. J Neurosci Rural Pract. 2018 Jan-Mar;9(1):73-79. doi: 10.4103/jnrp.jnrp_310_17. — 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 in which the bolus dose of sufentanil will be set as 2 µg with a lockout interval of 10 min and the maximum dose will be limited as 8 µg per hour. If the participates feel inadequate analgesia after 5 times of sufentanil bolus, the bolus dose will be increased to 3 µg and the maximum dose will be increased to 12 µg per hour.	Within 48 hours after the operation
Secondary	The number of participants who have no sufentanil consumption	The number of participants who have not pushed the button of patient-controlled analgesia pump. Both of the initial dose and background infusion of the patient-controlled analgesia pump in this study will be set as 0. 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 after the operation
Secondary	Numerical rating scale of pain	Pain was assessed after surgery by a 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, 3 months and 6 months after surgery
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	Ramsay Sedation Scale	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	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Secondary	Respiratory depression	Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.	Within 48 hours after the operation
Secondary	Heart rate		Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Secondary	Mean arterial pressure		Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and 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	Patient satisfactory scale (PSS)	0 for unsatisfactory, and 10 for very satisfied	At 48 hours, 1 week, 1 month, 3 months and 6 months after surgery
Secondary	The total consumption of opioids during the operation		During procedure
Secondary	The total consumption of anaesthetic during the operation		During procedure
Secondary	The duration of hospitalization after the operation		Approximately 2 weeks after the operation
Secondary	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.	At 1 month, 3 months and 6 months after surgery
Secondary	Incisional related adverse events Incisional related adverse events	Including delayed incisional healing, incisional infection, intracranial infection, scar healing	Within 1 month after 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 3 weeks and 6 weeks after surgery
Secondary	Patient and Observer Scar Assessment Scale	The Patient and Observer Scar Assessment Scale includes subjective symptoms of pain and pruritus and consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale. It assesses vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). and it incorporates patient assessments of pain, itching, color, stiffness, thickness, relief and overall opinion. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).	At 6 months after surgery