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Pre-emptive scalp infiltration with dexamethasone plus ropivacaine for postoperative pain after craniotomy: a protocol for a prospective, randomized controlled trial.

ABSTRACT: Background: Approximately 55-87% of the patients undergoing craniotomy experience moderate to severe pain during the first 48 hrs after surgery, which negatively influences patients' postoperative rehabilitation. Recently, local infiltration of analgesia (LIA) has been widely performed clinically as a promising analgesic method that could avoid the side effects of analgesics but only has a short pain-free duration; researchers have clarified that the addition of dexamethasone to LIA could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of dexamethasone to LIA for patients receiving craniotomy. The aim of the study was to test the hypothesis that pre-emptive scalp infiltration with a steroid (dexamethasone) plus a local anesthetic (ropivacaine) could achieve superior postoperative analgesic effects to a local anesthetic (ropivacaine) alone in adult patients undergoing a craniotomy. Study design and methods: This study is a randomized controlled trial that will include one intervention and one control group involving a total of 140 adults scheduled for elective craniotomy for resection of supratentorial tumors under general anesthesia and with an anticipated full recovery within 2 hrs postoperatively. The intervention will involve pre-emptive scalp infiltration with ropivacaine plus dexamethasone (the dexamethasone group) or ropivacaine alone (the control group), and the participants in both groups will complete a 6-month follow-up. The primary outcome will be the cumulative sufentanil consumption within 48 hrs postoperatively. Discussion: The intervention, if effective, this study will provide clinically important information on the role of dexamethasone in scalp infiltration for post-craniotomy pain management.

SUBMITTER: Jia Y

PROVIDER: S-EPMC6542215 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Pre-emptive scalp infiltration with dexamethasone plus ropivacaine for postoperative pain after craniotomy: a protocol for a prospective, randomized controlled trial.

Jia Yitong Y Zhao Chunmei C Ren Hao H Wang Tao T Luo Fang F

Journal of pain research 20190524

<b>Background:</b> Approximately 55-87% of the patients undergoing craniotomy experience moderate to severe pain during the first 48 hrs after surgery, which negatively influences patients' postoperative rehabilitation. Recently, local infiltration of analgesia (LIA) has been widely performed clinically as a promising analgesic method that could avoid the side effects of analgesics but only has a short pain-free duration; researchers have clarified that the addition of dexamethasone to LIA could ...[more]

PMID: 31213883

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Project description:IntroductionPatients undergoing major spine surgery usually experience moderate-to-severe postoperative pain. It has been shown that dexamethasone as an adjunct to local anaesthesia (LA) infiltration presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis reported that the overall benefits of dexamethasone infiltration were marginal. Dexamethasone palmitate (DXP) emulsion is a targeted liposteroid. Compared with dexamethasone, DXP has a stronger anti-inflammatory effect, longer duration of action and fewer adverse effects. We hypothesised that the additive analgesic effects of DXP on local incisional infiltration in major spine surgery may have better postoperative analgesic effect, compared with local anaesthetic alone. However, no study has evaluated this so far. The purpose of this trial is to determine whether pre-emptive coinfiltration of DXP emulsion and ropivacaine at surgical site incision will further reduce postoperative opioid requirements and pain scores after spine surgery than that with ropivacaine alone.Methods and analysisThis is a prospective, randomised, open-label, blinded endpoint, multicentre study. 124 patients scheduled for elective laminoplasty or laminectomy with no more than three levels will be randomly allocated in a 1:1 ratio into two groups: the intervention group will receive local incision site infiltration with ropivacaine plus DXP; the control group will receive infiltration with ropivacaine alone. All participants will complete a 3 months follow-up. The primary outcome will be the cumulative sufentanil consumption within 24 hours after surgery. The secondary outcomes will include further analgesia outcome assessments, steroid-related side effects and other complications, within the 3 months follow-up period.Ethics and disseminationThis study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital (KY-2019-112-02-3). All participants will provide a written informed consent. The results will be submitted for publication in a peer-reviewed journals.Trial registration numberNCT05693467.

Project description:Background Postoperative pain after craniotomy is an important clinical concern because it might lead to brain hyperemia and elevated intracranial pressure. Considering the side effects of opioid, several studies have been conducted to investigate the effect of local anesthetics, especially the scalp block, on postoperative pain. However, the strength of evidence supporting this practice for postoperative pain after craniotomy was unclear and the best occasion of scalp block was also not identified. Therefore, we conducted a meta-analysis to evaluate the efficacy, safety, and the best occasion of scalp block for postoperative pain after craniotomy. Methods PubMed, Embase, and the Cochrane Library databases from database inception to October 10, 2021 were searched for all randomized controlled trials evaluating the effect of scalp block on postoperative pain after craniotomy. Data were assessed by StataMP 16 software. Results A total of 12 studies were included. A random-effect model was used to analyze all data. Patients under scalp block earned fewer scores than the non-scalp block group in visual analogue scale at the very early period (MD = −1.97, 95% CI = −3.07 to −0.88), early period (MD = −1.84, 95% CI = −2.95 to −0.73) and intermediate period (MD = −1.16, 95% CI = −1.84 to −0.49). Scalp block could also significantly prolong the time of the first request of rescue analgesia and reduce the use of additional analgesics without a significant difference in the incidence of complications. Subgroup analysis showed there was no significant difference in analgesia effect between pre-incision scalp block and post-incision scalp block in all periods. Conclusion Scalp block could lead to lower pain intensity scores, more time of the first request of rescue analgesia, and fewer analgesic drugs applied in the first 12 h after craniotomy. There was no significant difference between pre-incision and post-incision scalp block in the occurrence and severity of postoperative pain.

Project description:BackgroundPostoperative pain after laminoplasty and laminectomy occurs partially from local trauma of the paraspinal tissue. Finding a multimodal analgesic cocktail to enhance the duration and effect of local infiltration analgesia is crucial. Because of rapid onset and long duration of action of betamethasone, we hypothesized that, a preemptive multimodal infiltration regimen of betamethasone and ropivacaine reduces pain scores and opioid demand, and improves patient satisfaction following laminoplasty and laminectomy.Materials and methodsThis prospective, randomized, open-label, blinded endpoint study was conducted between September 1, 2021 and June 3, 2022, and included patients between the ages of 18 to 64 scheduled for elective laminoplasty or laminectomy under general anesthesia, with American Society of Anesthesiologists classification I/II. 116 patients were randomly assigned to either the BR (Betamethasone-Ropivacaine) group or the R (Ropivacaine) group in a 1:1 ratio. Each group received preemptive infiltration of a total of 10 ml study solution into each level. Every 30 ml of study solution composed of 0.5 ml of Betamethasone plus 14.5 ml of saline and 15 ml of 1% ropivacaine for the BR group, and 15 ml of 1% ropivacaine added to 15 ml of saline for the R group. Infiltration of epidural space and intrathecal space were avoided and spinous process, transverse process, facet joints and lamina were injected, along with paravertebral muscles and subcutaneous tissue. Cumulative 48 hours postoperative butorphanol consumption via PCA (Patient-controlled analgesia) was the primary outcome. Intention-to-treat (ITT) principle was used for primary analysis.ResultsBaseline characteristics were identical in both groups (P>0.05). The cumulative 48 hours postoperative butorphanol consumption via PCA was 3.01.4 mg in the BR group (n=58), and 7.11.2 mg in the R group (n=58) (P<0.001). Overall cumulative opioid demand was lower at different time intervals in the BR group (P<0.001), along with the estimated median time of first analgesia demand via PCA (3.3 hours in the BR group and 1.6 hours in the R group). Visual Analogue Scale (VAS) score at movement and rest were also significantly lower until 3 months and 6 weeks, respectively. No side effects or adverse events associated with the intervention were observed in this study.ConclusionsPreemptive analgesia with betamethasone and ropivacaine provides better postoperative pain management following laminoplasty and laminectomy, compared to ropivacaine alone. This is an effective technique worthy of further evaluation.

Project description:BackgroundModerate-to-severe postoperative pain following craniotomy has a high incidence in pediatric patients. Such pain may cause agitation, intracranial hypertension, epileptic seizures, and postoperative hematoma, which affect morbidity and mortality. Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB with ropivacaine in pediatric patients undergoing craniotomy. In addition, the neurosurgery operation time is relatively long, but the duration of action of SNB is limited. It is generally believed that postoperative SNB is better than preoperative SNB for postoperative analgesia. However, considering the concept of preemptive analgesia, we believe that preoperative SNB may achieve a longer postoperative analgesia effect than we expected.MethodsThis trial is a single-institution, prospective, randomized, controlled, double-blind study. A total of 180 children aged between 1 and 12?years who are undergoing elective craniotomy will be randomly allocated in a 1:1:1 ratio to three groups: group B (preoperative ropivacaine block group), group A (postoperative ropivacaine block group), and group N (nonblocking control group). This randomization will be stratified by age in two strata (1-6?years and 7-12?years). The primary outcome is the total consumption of sufentanil within 24?h after surgery. The secondary outcomes include assessment of pain scores, total consumption of sufentanil and emergency-remedy medicine consumption at observation points, the occurrence of postoperative complications, and the length of hospitalization after surgery.DiscussionThis study is designed to explore the effect and feasibility of SNB with ropivacaine for postoperative analgesia in pediatric patients undergoing craniotomy. Further aims are to compare the effects of preoperative and postoperative SNB on postoperative analgesia in order to identify whether there is a preemptive analgesic effect and determine the better time to implement SNB in pediatric patients during craniotomy.Trial registrationChinese Clinical Trial Registry ChiCTR1800017386. Registered on 27 July 2018.

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Pre-emptive scalp infiltration with dexamethasone plus ropivacaine for postoperative pain after craniotomy: a protocol for a prospective, randomized controlled trial.

Publications

Pre-emptive scalp infiltration with dexamethasone plus ropivacaine for postoperative pain after craniotomy: a protocol for a prospective, randomized controlled trial.

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