Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02463370 |
| Other study ID # |
122014 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 13, 2015 |
| Last updated |
January 7, 2017 |
| Start date |
May 2015 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
January 2017 |
| Source |
Makassed General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Lebanon: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
Submucosal resection of the nasal septum (SMR) could be performed under local anesthetic
infiltration performed through ten injections in addition to general anesthesia which was
associated with less postoperative pain and shorter hospital stay.
However, the local infiltration technique is time-consuming and requires a large number of
facial injections. This gave rise to the idea of reducing the number of injections while
retaining the effectiveness of the local anesthetic technique.
Decreasing the number of injections could be achieved by blocking the superior maxillary
nerve (V2) and the infra-orbital nerve since it would result in anesthetizing the surgical
area as well after induction of general anesthesia.
The purpose of this prospective double-blind clinical trial was to compare the effectiveness
of four versus ten local anesthetic injections in terms of postoperative pain relief. The
secondary objective was to compare patients' and surgeons' satisfaction between the two
techniques.
Description:
Informed consent will be obtained from patients (ASA I and II) scheduled to undergo elective
submucosal resection of the nasal septum between May and November 2015.
The sealed envelope technique is used to randomly assign patients into two groups. The
anesthetists, surgeons, and nurses who collected the will be blinded to the study groups.
Patients in both groups will receive general anesthesia and six injections on each side of
the face at the following points: suprazygomatic maxillary (V2) area, infra-orbital area,
supratrochlear area, medial to the medial canthus, nasal still and anterior septum. Group II
patients will receive local anesthetic infiltration in two injections on each side of the
face at the maxillary and infra-orbital areas and the remaining injections are placebo
(saline). Group V patients will receive local anesthesia in five injections on each side of
the face at the infra-orbital area, supratrochlear area, medial to the medial canthus, nasal
still and anterior septum. The remaining maxillary injection is placebo.
To maintain double-blindness, three syringes (one 5 ml and two 10 ml) will be used for the
six injections. They are prepared by a nurse who is not involved in the study. The 5 ml
syringe (Becton Dickinson, Franklin Lakes New Jersey, USA) is labeled "F" indicating that it
should be used at the infra-orbital area for both groups. The total injected solution is
about 2 ml. One of the 10 ml syringes (Becton Dickinson, Franklin Lakes New Jersey, USA) is
labeled "I" indicating that it should be used for infiltration at the supratrochlear area,
medial to the medial canthus, nasal still and anterior septum. The total injected solution
is 6 ml. The second 10 ml syringe is labeled "Z" to be used for the suprazygomatic maxillary
nerve block.
The syringe labeled "F" always contains the local anesthetic solution. When syringe "I"
contains the anesthetic mixture (group V), then syringe "Z" is placebo. In contrary, when
syringe "Z" contains the anesthetic solution (group II), syringe "I" is placebo. The local
anesthetic mixture is composed of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, and 1 ml
fentanyl 50 µg/ml. In addition, syringe "F" contains 50 µg clonidine while syringes "I" and
"Z" have 100 µg clonidine (when they contain the anesthetic solution).
- Suprazygomatic maxillary nerve block technique:
The needle is inserted perpendicular to the skin and advanced to reach the greater wing of
the sphenoid. The needle is then angulated at 200 and 100 in the anterior and caudal
directions respectively. The needle is advanced about 3-3.5 cm through the pterygopalatine
fossa. The total amount of injected solution is 0.1 ml/kg with a maximum volume of 3.5 ml on
each side of the face.
- General anesthesia technique:
Induction of general anesthesia is achieved by using 1-2 mg/kg propofol, 1-1.5 µg/kg
intravenous fentanyl and 2-3 ml midazolam. Endotracheal intubation is facilitated by 0.5
mg/kg atracurium. Anesthesia is maintained using 1-1.5% sevoflurane, 0.5-0.75 µg/kg/hr
fentanyl, 70% nitrous oxide and 30% oxygen. Any hemodynamic change of ±25% from
pre-induction values results in a gradual increase or decrease of the sevoflurane
concentration.
- Surgical procedure:
Following preparation and draping of the nose, the septum is infiltrated using a solution of
xylocaine with 1% adrenaline. This would facilitate vasoconstriction and hydrodissection. A
hemitransfixion incision is made in which the mucoperiosteal and mucoperichondrial flaps are
elevated and then the deviated septum is resected. The flaps are sutured (Vicryl sutures)
and packed with two Merocel packs. The patients will be asked to visit the clinic after 48
hours to remove the packs.
- Data collection:
Data will be collected at predetermined time intervals by trained nurses. Patients will be
followed-up for ten postoperative days and contacted daily through phone calls after
hospital charge.
Mean arterial pressure (MAP) and heart rate (HR) are collected preoperatively, before
incision and post incision. Monitoring devices are pulse oximeter and noninvasive arterial
blood pressure. Postoperative pain is assessed at rest using the Numeric Rating Scale. The
number of patients who will consume analgesics is recorded. Pain scores, incidence of
oozing, headache, edema, hematoma, toothache, as well as postoperative nausea and vomiting
(PONV) are collected during the first postoperative day every six hours (at 0, 6 and 12
hours) and after that once daily for the next nine days. Postoperative oozing is defined as
changing three nasal dressings in 24 hours.
Patients' and surgeons' satisfaction will be asked to rate their satisfaction on a four
point scale (very satisfied, satisfied, little satisfied or dissatisfied). Surgeon
satisfaction is based on intraoperative hemodynamic stability of the patient and bleeding.
Postoperative surgeon satisfaction is dependent on patients' feeling of pain (especially
upon pack removal), bleeding and number of phone calls made to the surgeon. Surgeons are
asked to generally recall the number of calls.
Patients' satisfaction is based on their postoperative comfort determined by their feeling
of pain, headache and PONV.
- Postoperative pain management:
During the first 6 hours only, 1-1.5 mg/kg intravenous tramadol hydrochloride is given if
the pain score was four or greater. If the score was less than four, patients are given 1 g
intravenous perfalgan. After the first six postoperative hours, patients are given two
tablets 500 mg oral paracetamol if the pain score is less than four. In case paracetamol is
not sufficient, patients are prescribed 100 mg Voltarene, a non-steroidal anti-inflammatory
drug.
