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Completed

NCT Number: NCT06069804

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The TR group

Drug

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

Drug

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.

Primary outcomes

  1. Cumulative sufentanil consumption within 48 hours postoperatively

    Time frame: 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 outcomes

  1. The first time to press the patient-controlled analgesia button

    Time frame: Within 48 hours after the operation

    The first time that the participants press the patient-controlled analgesia button.

  2. The total times that participants press patient-controlled analgesia button

    Time frame: Within 48 hours postoperatively

    The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.

  3. Numerical rating scale (NRS)

    Time frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month,

    Pain will be assessed after surgery by numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).

  4. Postoperative nausea and vomiting

    Time frame: 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.

  5. The times of emergency reducing blood pressure after the operation

    Time frame: 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.

  6. The total consumption of opioids during the operation

    Time frame: During procedure

    The total consumption of opioids during the operation

  7. The length of stay

    Time frame: Approximately 2 weeks after the surgery

    The duration of hospitalization after the operation

  8. Wound Healing Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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