Clinical trial NCT00972790: Scalp Nerve Blocks for Post-Craniotomy Pain
Official title: Effect of Bilateral Scalp Nerve Blocks on Post-operative Pain and Discharge Times in Patients Undergoing Supra-tentorial Craniotomy and General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supratentorial Neoplasms
Aneurysms
Arteriovenous Malformation
Epilepsy
Keywords: brain tumor
un-ruptured aneurysm
arteriovenous malformation
epileptic focus
supratentorial
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2009-09-09
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate that scalp nerve blocks ("scalp freezing"), performed at the end of supratentorial brain surgery, will reduce post-operative pain, opioids side effects, and the time required for post-anaesthesia care unit (PACU)/Intensive Care Unit (ICU) and hospital discharge.

Detailed description: The proposed study is a randomized, placebo-controlled, triple-blinded, parallel-group clinical trial. Patients will be recruited from the neurosurgical population at St. Michael's Hospital.

The inclusion criteria are:

* Adults aged 18 years and over;
* scheduled for one of the following supratentorial craniotomy:

  1. resection of a brain tumour
  2. clipping of an un-ruptured cerebral aneurysm
  3. excision of an artero-venous malformation (AVM), or
  4. removal of an epileptic focus
* ASA physical status \< IV

Intervention group: scalp nerve blocks with 20 ml of bupivacaine 0.5% + epinephrine 1:200,000 (divided among the different injection sites) at the end of surgery and before removal of the endo-tracheal tube. Control group: equal injections with 20 ml of saline + epinephrine 1:200,000 (at same time). In both study arms, post-operative rescue analgesia will be provided with hydromorphone patient-controlled analgesia (PCA).

The primary outcome of this study will be the 24h post-operative pain score as assessed by the visual analogue scale (VAS).

Important secondary outcomes will be:

* the total PCA hydromorphone consumption in the first 24 and 48 post-operative hours;
* the incidence of nausea and vomiting in the first 24 and 48 post-operative hours;
* time to reach discharge eligibility from the PACU/ICU and hospital length of stay.

Patients will be asked to rate their pain using the VAS at 30 min, 1, 2, 4, 8, 12, 18, 24, and 48 h, postoperatively by the research coordinator/bedside nurse. Pain will be also assessed at 5, 30 and 60 days postoperatively with the use of a Numeric Rating Scale (0-10).

Eligibility criteria: Inclusion Criteria:

* adults aged 18 years and over;
* patients scheduled for elective craniotomy under general anaesthesia for one of the following surgeries:

  * resection of a supratentorial brain tumour,
  * clipping of an un-ruptured supratentorial cerebral aneurysm,
  * excision of a supratentorial arterio-venous malformation (AVM),
  * removal of an epileptic focus under general anaesthetic.
* ASA physical status \< IV.

Exclusion Criteria:

* history of significant coronary artery disease (NYHA class III or IV) which would contraindicate the use of epinephrine;
* presence of pain related to the intracranial pathology (e.g. tumour pain) since it could make difficult the discrimination between the tumour pain itself and the surgery related pain;
* current history of alcohol abuse or recreational drug abuse;
* active psychotic disorder;
* history of chronic pain requiring chronic opioids use (patients on opioids for \> 2 weeks);
* known or suspected addiction to narcotic substances;
* presence of any acute distracting pain;
* history of migraines;
* inability to understand or incapacity to use the VAS;
* proven or suspected allergy to local anaesthetics;
* craniotomy incision extending beyond the field of the block;
* predicted need for postoperative ventilation;
* history of scalp paresthesia or scalp scarring that may preclude normal nerve anatomy;
* previous craniotomy or cranial irradiation;
* history of malignant hyperthermia, which would contraindicate the anaesthesia maintenance protocol of this study;
* pregnancy.

Primary outcomes:
measure: The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.
timeFrame: 24 hours
Secondary outcomes:
measure: 48h post-operative pooled VAS score
timeFrame: 48 hours
measure: the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours
timeFrame: 24 and 48 hours
measure: total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours
timeFrame: 24 and 48 hours
measure: the incidence of nausea and vomiting in the first 24 and 48 post-operative hours
timeFrame: 24 and 48 hours
measure: the time for patients to reach discharge eligibility from the PACU/ICU
timeFrame: Discharge time and date from PACU/ICU
measure: the time for patients to reach discharge eligibility from hospital
timeFrame: Discharge time and date from hospital
measure: presence of long term pain as measured with the Numeric Rating Scale (NRS) at days 5, 30 and 60 postoperatively
timeFrame: 5, 30 and 60 days
measure: Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5
timeFrame: day 5
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital, University of Toronto
name: Andrea Rigamonti, MD, MSc (c)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rigamonti A, Garavaglia MM, Ma K, Crescini C, Mistry N, Thorpe K, Cusimano MD, Das S, Hare GMT, Mazer CD. Effect of bilateral scalp nerve blocks on postoperative pain and discharge times in patients undergoing supratentorial craniotomy and general anesthesia: a randomized-controlled trial. Can J Anaesth. 2020 Apr;67(4):452-461. doi: 10.1007/s12630-019-01558-7. Epub 2019 Dec 26.