Clinical Trial: Inferior Alveolar Nerve Block for Intraoperative Analgesia for Maxillofacial Cancer Surgery - RCT

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Inferior Alveolar Nerve Block for Intraoperative Analgesia for Maxillofacial Cancer Surgery Requiring Unilateral Mandibular Resection-A Randomized Controlled Study

Brief Summary: Mandibular resection which is an important component of maxillofacial cancer surgery is an extremely painful procedure associated with severe sympathetic response needing high doses of opioids. Inferior alveolar nerve block is a common nerve block used by dentists for mandibular dental extractions. The aim of this trial is to study the effect of this block for intraoperative analgesia in maxillofacial cancer surgeries requiring unilateral mandibular resection.

Detailed Summary:

All adult patients below 75yrs of age scheduled for maxillofacial surgery will be screened for inclusion and exclusion criteria.

Written informed consent will be taken one day prior to surgery. Consenting subjects will be randomized after induction of anaesthesia to study or control arm.

The duration of the study is from induction of anaesthesia to the completion of primary tumour removal and neck dissection

Study procedure: Ipsilateral Inferior alveolar nerve block A long acting local anaesthetic agent Inj Bupivacaine hydrochloride 0.5% (2 ml) will be given after induction by open mouth technique by landmark method.

The mucobuccal fold will be palpated and traced till coronoid notch. The finger will be moved medially across the retromandibular trigone on internal oblique ridge. The 25G needle will be inserted till bone is felt. 2 ml of 0.5% bupivacaine will be injected slowly after withdrawing needle by 1mm and confirming negative aspiration of blood.

Control arm will not receive any intervention. The study investigator will give a mock injection for blinding of the attending anaesthetist

The study procedure will be done by the study investigators 10 -30 minutes prior to commencing surgery for primary tumour.

Account of procedure:

All patients will have standard conduct of anaesthesia except for the alveolar nerve injection in the study group.

All patients will have the minimum standard monitoring of pulse oximeter, electrocardiogram, capnography and non invasive blood pressure
Sponsor: Tata Memorial Centre

Current Primary Outcome: IV fentanyl requirement during primary tumour removal [ Time Frame: From start to finish ofprimary tumour removal procedure ]

The total IV fentanyl dose required during primary tumour removal will be noted


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • IV fentanyl requirement during neck dissection and primary tumour removal [ Time Frame: From start to finish of neck dissection and primary tumour removal ]
    The total IV fentanyl dose required during neck dissection and primary tumour removal will be noted
  • Maximum change in heart rate from baseline during primary tumour removal [ Time Frame: From start to finish of primary tumour removal procedure ]
  • Maximum change in blood pressure from baseline during primary tumour removal [ Time Frame: From start to finish of primary tumour removal procedure ]
  • Need for rescue analgesics or vasoactive agents during primary tumour removal [ Time Frame: From start to finish of primary tumour removal procedure ]


Original Secondary Outcome: Same as current

Information By: Tata Memorial Centre

Dates:
Date Received: April 15, 2016
Date Started: June 2016
Date Completion:
Last Updated: November 20, 2016
Last Verified: November 2016