Comparison of USG guided Unilateral Subcostal Transversus Abdominis Plane block (SCTAPB) with Modified Block for Branches of Intercostal Nerve at level of Midaxillary Line (BRILMA) as a part of Multimodal Analgesia in Laparoscopic Cholecystectomy- A Randomized Controlled Trial

AIM OF STUDY

Comparison of USG guided Unilateral Subcostal Transversus Abdominis Plane Block with Modified BRanches of Intercostal nerve at Level of Mid-axillary Line (BRILMA) using Inj. Ropivacaine 0.2% as a part of Multimodal Analgesia in Laparoscopic Cholecystectomy.

OBJECTIVES

Primary Objective:-

To Compare Postoperative Analgesia of USG guided unilateral Subcostal TAP with Modified BRILMA block with Inj 0.2 % Ropivacaine.

Secondary objective:

Total Consumption of Rescue Analgesia in Postoperative Period

Perioperative Hemodynamic Changes

Complications (Pneumothorax/Hematoma, LA toxicity)

STUDY PROTOCOL

ETHICAL CONSIDERATION:- This Study will be Conducted after obtaining Ethical Approval by Local Ethical committee of GMERS Medical College and Hospital, Gotri, Vadodara and topic being registered with CTRI (Clinical Trial Registry of India)

STUDY DESIGN:- Prospective Randomized Controlled, Double Blind clinical study

STUDY PLACE:-General Surgery operating unit in a tertiary Care teaching Hospital (GMERS Medical College and Hospital, Vadodara)

STUDY PERIOD:- approximately 6-12 months after the approval from Ethical Committee.

STUDY POPULATION:- Total 40 Adults with Comparable Demographic profile, posted for Laparoscopic Cholecystectomy Surgery, consenting for administration of both blocks.

SAMPLE SIZE:-Sample size of 32 patients taking into consideration the time taken for first rescue analgesia from Study comparing Modified BRILMA with unilateral Subcostal TAP block (different from ours) by STATULATOR software taking 95% Precision and power 80% after discussion with Statistics Department. Extra 10 % will be added to cover up for loss to follow up.

INCLUSION CRITERIA

Patients posted for Laparoscopic Cholecystectomy consenting for Administration of Block

Age: 18-60 years

Weight 50-80 kilogram

ASA physical status I-II

EXCLUSION CRITERIA

Patient Refusal

Local site infection

Allergic to study drugs

Altered coagulation profile

On chronic Pain Medication

RANDOMIZATION

After Considering Inclusion/Exclusion criteria, the patients will be randomly allocated into two equal groups by using computer generated random sequence.

Group B:- Modified BRILMA block

Group T:- Subcostal TAP block

BLINDING

The generated number list will be concealed using opaque envelope method & opened only on the day of surgery by the consultant to the primary investigator (performing the blocks) of the team. The double blinding will be ensured by not disclosing the groups to the patients & the observer assessing the analgesic effect of block.

Thorough Pre-op assessment will be carried out for each patient prior Surgery. On the day of surgery, after confirming the NPO status for 6 hours and noting Baseline Vital Parameters, all patients will be shifted to OT.

After premedication with Inj Glycopyrrolate 0.004mg/kg IV, Inj Midazolam 0.03mg/kg IV, Inj Ondansetron 0.08mg/kg IV, and Inj Fentanyl 2 mcg/kg IV.

All patients in both the groups will receive General Anaesthesia as per Instituitional protocol .Using Inj Propofol 2mg/kg IV as induction agent and Inj Succinylcholine 2mg/kg IV and Inj Vecuronium 0.1 mg/kg IV as muscle Relaxant.

Airway will be secured with Endotracheal Tube and Anaesthesia will be maintained with Air/oxygen, Sevoflurane and Vecuronium in both Groups.

After Induction of Anaesthesia, with all aseptic and antiseptic precautions patient will receive either USG Guided Unilateral Subcostal TAP block or Modified BRILMA block using 5-13 Hz High frequency Linear Probe with 100 mm Insulating Needle (Stimulex, B Braun) to perform Block.

All blocks will be given by Principal Investigator (minimum experience of giving 10 blocks each).

Total volume of 20 ml of 0.2% Inj Ropivacaine will be given in both the Groups.

USG GUIDED MODIFIED BRILMA BLOCK

Under all aseptic and antiseptic precautions,Patient in Left Lateral Decubitus

Linear Probe in Sagittal Plane at Mid-axillary line at Level of 8th Rib on Right side.

Identify Fascial Plane between Serratus Anterior Muscle and External Intercostal Muscle.

Insert Needle by in plane technique.

After negative aspiration of Blood, total volume of LA will be given in Serratus-intercostal Fascia thereby causing lifting of serratus anterior muscle from the Rib under USG Guidance .

USG GUIDED UNILATERAL SUBCOSTAL TAP BLOCK

Under all aseptic and antiseptic precautions,Patient in supine position

Probe below Xiphisternum in Transverse plane and move laterally parallel to Right costal margin to see lateral muscles of anterior abdominal wall.

Identify plane between posterior sheath of Rectus Abdominis and Transversus abdominis.

Insert needle by in plane technique

After negative aspiration of Blood, total volume of LA will be given causing cephalic and caudal spread of LA between rectus abdominis and transversus abdominis muscle under USG

Guidance.

Inj Dexamethasone 0.2mg/kg IV will be given after giving Block.

Intravenous crystalloid 20ml/kg will be administered before creating pneumo-peritoneum.

End tidal carbon dioxide will be maintained between 35-40mmhg.

Mean arterial pressure (MAP) will be maintained.

Ondansetron 4 mg and paracetamol 1 gm IV will be given during Surgical closure.

Block Administration Time (from insertion of needle to removal of needle), Duration of Surgery (from Skin incision to closure) and duration of Anaesthesia (induction to extubation) will be recorded.

Patients will be extubated and shifted to post anaesthesia care unit for monitoring.

ASSESSMENT OF ANALGESIA

Analgesic effect of Block will be assessed using VAS score at rest (end of surgery,30 minute, 2, 6,12, and 24 hour) and during activity upto 24 hours by observer who is blinded to type of block given.

If VAS>3, Inj Tramadol 1.5 mg/kg IV will be given as Rescue analgesia.

Thereafter Inj Tramadol 1.5 mg/kg IV will be given round the clock for 24 hours.

Total duration of analgesia is considered from Time of block administration to first Rescue analgesia requirement in postoperative period.

Total Consumption of rescue analgesia during period of observation will be documented.

All patients will receive Inj paracetamol 1 gm IV 6 hourly as part of multimodal analgesia to cover the epigastric port insertion site which may be spared in both the blocks.

Any complications related to Subcostal TAP block like intraperitoneal or intravascular injection, LA toxicity or hematoma formation and by modified BRILMA block like pneumothorax, intravascular injection or LA toxicity will be noted.

Failed Block:- Patients having inadequate Local Anaesthetic spread in correct fascial plane and any block related complications will be excluded from the study

OUTCOME MEASURES

Primary outcome:-

Postoperative VAS score at rest and at activity.

Time required for first rescue analgesia observed in both study groups

Secondary Outcome:-

Total consumption of Rescue analgesia in postoperative period upto 24 hours

Duration of Block administration

Perioperative Hemodynamic Changes (HR, MAP, SpO2)

Complications (Pneumothorax, LA toxicity)