Lidocaine Versus Bupivacaine for Sphenopalatine Ganglion Block

NCT ID: NCT05269147

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-09-01

Brief Summary

The endoscopic septoplasty technique is one of the most frequently performed operations by otolaryngologists throughout the world. It is suggested that 86% of patients who undergo an endoscopic septoplasty would experience pain, and 75% of them suffer moderate to extreme levels of pain. Appropriate management of post-operative pain is a critical component of nasal surgery as it reduces perioperative morbidity, complications, hospital stay, and costs.

The sphenopalatine ganglion (SPG) is located in the cranial section of the autonomous nervous system; it is connected with the brain stem and the central nervous system (CNS) and bears unique characteristics favorable for the treatment of many painful syndromes involving the face and head. Sphenopalatine ganglion block (SPGB), along with general anesthesia (GA), is one of the regional anesthetic techniques used to reduce the need for systemic analgesia and provides relative hypotension with controlled heart rate that may lead to a better surgical field for endoscopic surgery. In addition, SPGB appears to shorten hospital stays and reduce narcotic requirements in the recovery area. SPGB with bupivacaine delivered repetitively appears to decreased postoperative pain and more satisfaction with the surgery for patients. Also, Bupivacaine usage in nasal surgery provides better analgesia at least in the first 8 hours period and does not cause more bleeding. On the other hand, SPGB with lidocaine was found to decrease the need for additional analgesics in the postoperative period, increase patient satisfaction, decrease the length of hospital stay, and as a consequence, reduce the rate of secondary infections. However, no previous studies have demonstrated the superiority of one drug over the other when performing an intranasal SPG block.

Aim of the work: To determine the efficacy of lidocaine versus bupivacaine for sphenopalatine ganglion block in patients undergoing endoscopic septoplasty.

Detailed Description

Methods:

Eligible patients will be evaluated by:

Preoperative:

Explanation of visual analog scale will be done to patients (the VAS consists of a straight, vertical 10-cm line; the bottom point represented "no pain" = (0 cm) and the top "the worst pain you could ever have" = (10 cm).

Randomization:

All patients fitting the inclusion criteria will be randomly allocated using computer-generated numbers into one of three groups. Labeled slips will be put in serially numbered opaque and sealed envelopes. They will be opened when an eligible patient will be enrolled by an independent worker, not worked in the study.

Group A (20 patients): patients will receive standardized general anesthesia + SBGB with normal saline.

Group B (20 patients): patients will receive standardized general anesthesia + SBGB with lidocaine 2% Group C (20 patients): patients will receive standardized general anesthesia+ SBGB with bupivacaine 0.5%

All patients will not receive anything per oral for at least 6 hours before a procedure. On arrival at the operation theatre, standard monitoring will be connected. Mean blood pressures (MBP), heart rate (HR) will be measured before the block (0 min.) and then every 10 minutes after the block till recovery time.

The patients will be received standardized GA protocol as follows:

1. Induction with propofol (1-2 mg/kg body weight),

2. Atracurium as a muscle relaxant (1 mg/kg body weight),

3. Isoflurane as a volatile anesthetic agent in 50% O2 and air, and

4. Analgesia with fentanyl (1 microgram/kg body weight). The total doses of fentanyl that were used during the operation will be recorded.

The patient will be evaluated intraoperatively and postoperatively for :

The Scoring criteria for an intraoperative surgical field using Fromme ordinal scale:

0 No bleeding

1. Slight bleeding but no suctioning of blood required

2. Slight bleeding with occasional suctioning required; surgical field not threatened

3. Slight bleeding with frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed

4. Moderate bleeding with frequent suctioning required; bleeding threatens the surgical field directly after suction is removed

5. Severe bleeding with constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery not possible

Postoperative Post-operative pain will be questioned by an anesthesiologist with a Visual Analog Scale (VAS) (0 = no pain, 10 = most severe pain) at the 30th minute(t1), 1st hour(t2), 4th hour (t3), 12th hour (t4) and 24th hours (t5) and analgesia was managed according to the VAS scores. If the VAS score is ≥ 4, the patient will be given rescue analgesia in the form of intravenously Pethidine 50mg.

The data on Postoperative nausea and vomiting will be collected by direct questioning by the anesthesiologist at the same time as pain score assessment. If there is 1 min between the episodes of vomiting, each one will be considered a separate episode. Every episode of vomiting will be scored as 1 point and the total score will be calculated after 24 hours.

Conditions

Septum; Deviation, Congenital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SBGB with normal saline

patients will receive standardized general anesthesia + SBGB with normal saline.

Group Type: PLACEBO_COMPARATOR

Sphenopalatine Ganglion Block (SPGB)

Intervention Type: PROCEDURE

The SPGB will be done after the patient is generally anesthetized and will be performed by the operating surgeon using a transnasal endoscopic approach through the posterior and over the middle turbinate tail in the pterygopalatine fossa.

The patient will be placed in the supine position with head extension. The prepared solution (4 ccs 2% lidocaine or 0.5% bupivacaine or normal saline and 1 cc 8 mg dexamethasone) will be given (2,5 cc) to each side of the nose.

The surgery was started 10 minutes after the application of SPBG to allow sufficient time for the block to develop.

SBGB with lidocaine 2%

patients will receive standardized general anesthesia + SBGB with lidocaine 2%

Group Type: ACTIVE_COMPARATOR

Sphenopalatine Ganglion Block (SPGB)

Intervention Type: PROCEDURE

The SPGB will be done after the patient is generally anesthetized and will be performed by the operating surgeon using a transnasal endoscopic approach through the posterior and over the middle turbinate tail in the pterygopalatine fossa.

The patient will be placed in the supine position with head extension. The prepared solution (4 ccs 2% lidocaine or 0.5% bupivacaine or normal saline and 1 cc 8 mg dexamethasone) will be given (2,5 cc) to each side of the nose.

The surgery was started 10 minutes after the application of SPBG to allow sufficient time for the block to develop.

SBGB with bupivacaine 0.5%

patients will receive standardized general anesthesia+ SBGB with bupivacaine 0.5%

Group Type: ACTIVE_COMPARATOR

Sphenopalatine Ganglion Block (SPGB)

Intervention Type: PROCEDURE

The SPGB will be done after the patient is generally anesthetized and will be performed by the operating surgeon using a transnasal endoscopic approach through the posterior and over the middle turbinate tail in the pterygopalatine fossa.

The patient will be placed in the supine position with head extension. The prepared solution (4 ccs 2% lidocaine or 0.5% bupivacaine or normal saline and 1 cc 8 mg dexamethasone) will be given (2,5 cc) to each side of the nose.

The surgery was started 10 minutes after the application of SPBG to allow sufficient time for the block to develop.

Interventions

Sphenopalatine Ganglion Block (SPGB)

The SPGB will be done after the patient is generally anesthetized and will be performed by the operating surgeon using a transnasal endoscopic approach through the posterior and over the middle turbinate tail in the pterygopalatine fossa.

The patient will be placed in the supine position with head extension. The prepared solution (4 ccs 2% lidocaine or 0.5% bupivacaine or normal saline and 1 cc 8 mg dexamethasone) will be given (2,5 cc) to each side of the nose.

The surgery was started 10 minutes after the application of SPBG to allow sufficient time for the block to develop.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. The patients planned to perform endoscopic septoplasty

2. American Society of Anesthesiologists class I and II

Exclusion Criteria

1. patients that will be received additional surgery with endoscopic septoplasty

2. patients under the age of 18

3. Patients have systemic or bleeding disorders

4. patients who disincline to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huda Fahmy Mahmoud, PhD

OTHER

Sponsor Role: lead

Responsible Party

Huda Fahmy Mahmoud, PhD

Assistant professor of Anaesthesia and Intensive Care department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

huda F fahmy

Role: PRINCIPAL_INVESTIGATOR

Aswan University

Locations

Huda Fahmy

Aswān, , Egypt

Countries

Egypt

Other Identifiers

506/1/21

Identifier Type: -

Identifier Source: org_study_id