The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

Makassed General Hospital

Status: Suspended

Conditions: Post Operative Pain

Treatments: Other: Placebo; Other: General anesthesia; Other: Infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT03806335

32015

Details and patient eligibility

About

Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. Hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.

Full description

The study will be conducted prospectively, using a randomized double-blind design. Adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2019 till January 2020 will be included.Patients will be allocated randomly into two equal groups using the sealed envelope method. Both groups will receive general anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. The second group will have placebo infiltration.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with total or partial tonsillectomy with or without adenoidectomy

Exclusion criteria

• patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma
• patients who have diabetes
• patients who have bleeding problems
• patients who are suspected to have signs of acute pharyngeal infection

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Infiltration

Experimental group

Description:

Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.

Treatment:

Other: Infiltration

Other: General anesthesia

Placebo

Placebo Comparator group

Description:

Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.

Treatment:

Other: Placebo

Other: General anesthesia