General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21+
SponsorTanta University

About this trial

This study aims to compare general anesthesia and spinal anesthesia with local anesthetic infiltration for buccal mucosal graft (BMG) in urethroplasty.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patient age ≥ 21 years.

American Society of Anesthesiologists (ASA) classification I-II.

Patient scheduled for urethroplasty.

Disqualifiers

Patients who are taking analgesics for chronic illness or have a history of substance abuse.

Patients who are unable to describe their postoperative pain (e.g., neuropsychiatric disorder).

Patients with known local anesthetics and opioid allergy.

Patients with infection at the site of the needle puncture.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal anesthesia

    Other intervention

    Patients will receive spinal anesthesia with local anesthetic infiltration.

  • General anesthesia

    Other intervention

    Patients will receive general anesthesia.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group SExperimental treatment 1 intervention
Group B: Group GActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Degree of pain

Each patient will be instructed about postoperative pain assessment with the Numerical rating Scale (NRS). NRS (0 represents "no pain"; (1-3) mild pain; (4-6) moderate pain; (7-10) severe pain. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.

Time frame
24 hours postoperatively

Secondary outcomes

1

Postoperative morphine consumption

Rescue analgesia of morphine will be given as 3 mg bolus if the Numerical rating Scale (NRS)\> 3 to be repeated after 30 min if pain persists until the NRS\< 4.

Time frame
24 hours postoperatively
2

Operative time

Operative time will be recorded from the induction of anesthesia to discharge to the post-anesthesia care unit (PACU).

Time frame
Till discharge to post-anesthesia care unit (Up to 2 hours)
3

Length of hospital stay

Length of hospital stay will be recorded from admission till the discharge from the hospital.

Time frame
Till discharge from hospital (Up to one week).
4

Patient satisfaction

• Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely unsatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

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