Multifidus Cervicis and Inter-Semispinal Plane Blocks in Analgesia After Cervical Spine Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorZagazig University

About this trial

Major spine surgery with multilevel instrumentation is followed by a large amount of opioid consumption, significant pain, and difficult mobilization Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesic techniques is of paramount importance. Moreover, early intervention in rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily activity. Effective pain management is one of the crucial components in enhanced recovery after surgery (ERAS).

Numerous regional anesthetic techniques have been used to provide analgesia following cervical spine surgery, including patient-controlled epidural analgesia, cervical paravertebral block, cervical plexus block, cervical erector spinae plane blocks, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for such surgeries.

Up to the author's knowledge, there is no study done to compare multifidus cervicis plane block versus inter-semispinal plane block in a randomized controlled clinical trial as preemptive analgesia in patients undergoing cervical spine surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient acceptance.

Age 21-60 years old.

BMI ≤ 30 kg/m2

ASA I - II.

Disqualifiers

History of allergy to the LA agents used in this study

Skin lesion at the needle insertion site,

Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders

History of chronic pain and taking analgesics

Trial design

Design model

Parallel

Treatments tested in this trial

  • control group

    Procedure/Surgery

    patients will be operated under general anesthesia

  • MCP group

    Procedure/Surgery

    patients will receive ultrasound-guided MCP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.

  • ISP group

    Procedure/Surgery

    patients will receive ultrasound-guided ISP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: control groupPlacebo comparator 1 intervention
Group B: MCP groupActive comparator 1 intervention
Group C: ISP groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

changes in Visual analogue scale (VAS)score

On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain

Time frame
measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively

Secondary outcomes

1

Total dose of rescue analgesia

once the VAS score will be ≥ 3, rescue analgesia in the form of 0.1 mg/kg nalbuphine will be given and the total dose consumed will be recorded

Time frame
in the first 24 hour postoperatively
2

the first time to rescue analgesia

the time from the end of operation to patient reporting VAS ≥ 3

Time frame
in the first 24 hour postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.