Pain relief for laparoscopic gallbladder removal
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/06/054243
- Lead Sponsor
- SRM Institute of Science and Technology
- Brief Summary
Laparoscopic cholecystectomy is a minimally invasive procedure that causes moderate intensityof parietal, visceral,incisional and referredpostoperative pain. A multimodal analgesic approach for management of suchvariety of pain is usually used for enhanced recovery of the patient. As apart of this approach, TAP blockis a famous modality for postoperative analgesiain laparoscopic abdominal surgeries,which was first reported by Rafi. It is an abdominalfield block that acts on the myocutaneous nerve supply of anterior abdominal compartment, targeting parietal and incisional components of pain. The anatomical compartment betweenthe transversus abdominis muscle and abdominal obliqueinternus muscle was described as TAP in clinical practice. The bolus anesthetic injection into this neurovascularfascial plane provides the anesthesiologistto block the dermatomal afferents of T7-11 intercostal nerves, T12 subcostal nerve, ilioinguinal and iliohypogastricnerves, and cutaneous branches of L1-3 nerves. The inferior lumbar triangle(triangle of Petit)which is an upright triangleand contains three major layers from superficial to deep:Subcutaneous fatty tissue, the abdominis obliquus internus muscle and transversus abdominis muscleand their fascias, is located among the anterior margin of the latissimus dorsi muscle, posterior margin of theabdominis obliquus externus muscle and inferiorly the crista iliaca.Its apex is the major anatomic landmarkof the insertion. Thistriangular region is also known as a weak area in the posterior abdominal wall.The most common approachof performing TAP block with ultrasound for laparoscopic cholecystectomy is the classical or posterior one, which provides analgesiabetween T7 to the level of T10dermatome. The rationale for performingsubcostal TAP block (described byHebbard) is to achieve the extent of the block upto the T6 dermatome, where the epigastricport of laparoscope is inserted for which the block is required to be given ata more anterior level. In thisstudy, we attempt to compare the efficacy of right sided subcostal TAP block along with port site infiltration of local anaesthetic, with that of port site local anaesthetic infiltration alone in providing adequate post operative analgesia.
**STUDY JUSTIFICATION**
Thisstudy was designed to compare the efficacy of subcostal TAP block administeredby the surgeon under laparoscopyguidance along with port site local anaesthetic infiltration, with that of port site infiltration alone, inproviding adequate post operative analgesia. If TAP block can be made a routine, it will be possible to savehospital resources, reduce hospital stay, as wellas patient expenditure.
**AIMS AND OBJECTIVES:**
Tocompare the efficacy of pre emptive laparoscopy guided subcostal TAP blockalong with port site inflitration,with that of port site infiltration alone in terms of:
1. Levelsof post-operative pain, monitored and recorded as per VAS scoring system
2. Incidence of breakthroughpain
3. Duration of post-operative hospitalstay
**REVIEW OF LITERATURE**
It is well-known that less post-operative pain and rapid improvement inphysical activity are the most important advantages of minimally invasivesurgery[1]. Nevertheless, many patients suffer from significant pain afterlaparoscopic abdominal surgeries[2,3] including laparoscopic cholecystectomy. For pain control afteropen or laparoscopic abdominal surgery, different local methods ofanesthesia have been described. So far, transversus abdominis plane (TAP) block technique which was first reportedby Rafi [4], seems to offer aneffective local pain control to the patients. Owen et al. [5] first describedthe open surgical approach for TAPblock. A few years later, in 2011, pure laparoscopic TAP block was reported as a new technique [6]. Bothtechniques allow surgeons to apply TAP block under direct vision prior to the surgery. The anatomical compartmentbetween the transversus abdominismuscle and internal oblique muscle was described as TAP in clinical practice [3,7]. The bolus anesthetic injection intothis neurovascular fascial plane provides block to the dermatomal afferents of T7-11 intercostal nerves, T12subcostal nerve, ilioinguinal and iliohypogastricnerves, and cutaneous branches of L1-3 nerves [8,9]. It is also known that the anatomical variations of the nerveentries and exits of the TAP are common. The inferior lumbar triangle (triangle of Petit) which is an uprighttriangle, contains three major layers fromsuperficial to deep: Subcutaneous fatty tissue, the abdominis obliquus internusmuscle and transversus abdominis muscle and their fascias,and is located among the anterior margin
of the latissimus dorsi muscle, posterior margin of the external obliquemuscle and inferiorly the iliaccrest. Its apex is the major anatomic landmark of the insertion [8]. Thistriangular region is also known asa weak area in the posteriorabdominal wall. The apexof the triangle of Petithas been described as the “blind†insertion point of the needle. On the otherhand, recent studies propose the useof an ultrasound probe for needle placement because of the potential risk for damage to adjacentstructures. Magee et al.[6] performed TAP block under direct laparoscopic vision prior to laparoscopic surgicalintervention and suggested the approach as an alternative method to avoid iatrogenic injuries.
The conventional methodof giving a TAP block is the posterior TAP block. However, therehave been reports that the posterior TAP block mainly provides analgesiabelow the T10 dermatomal level, and is thus more suitable for abdominal incisions below the umbilicus.
Hebbard [10] described a new technique called the subcostal TAP block,which involves depositing localanesthetic in a more cephalad position, immediately inferior to the costal margin on the anterior abdominal wall.The drug is injected at this location, immediately lateral to the linea semilunaris in the TAP. Subcostal TAPblocks are thought to be more effective in providing analgesia for incisionsin the supra-umbilical region [10].
In the study, we aim to demonstrate the effectiveness of pre emptivelaparoscopy assisted subcostaltransversus abdominis plane block along with port site infiltration of local anaesthetic in providing post operative analgesiafollowing laparoscopic cholecystectomy
**HYPOTHESIS**
Pre emptivecombined TAP block+ port site local anaesthetic infiltration provides better post operative analgesia, compared to port site infiltration alone, in laparoscopic cholecystectomy.
**MATERIALS& METHODS**
**TYPE OF STUDY:** Prospective Study
**STUDY DESIGN**: Randomized controlled trial (Single blinded)
**PLACE OF STUDY:**
SRM MEDICALCOLLEGE HOSPITAL AND RESEARCH CENTRE
**PERIOD OF STUDY:**6 MONTHS (Aug 2020-Jan 2021)
**STUDY POPULATION:**
Allpatients admitted with the clinical diagnosis of cholelithiasis under GeneralSurgery care in SRM MEDICAL COLLEGEHOSPITAL AND RESEARCHCENTRE would be taken as
Subjects for this study.
**SAMPLESIZE:** All patients attending General Surgery OPD in the study period for cholelithiasis shall be encouraged to participate in the study
Group A:patients shall receive pre emptive subcostal TAP block with port siteinfiltration Group B: patients shall receive port site infiltration alone
**Sample size was calculated using the following formula**
k=n2/n1=1
**Δ2**
n1= (1.42+1.42/1) (1.96+0.84)2
**1.462****n1=15****n2=K****∗****n1=15**
**INCLUSION CRITERIA**
â— All patients with cholelithiasis admitted under the General Surgery departmentin SRM Medical CollegeHospital and Research Centre fulfilling the following criteria:
1. ASA I, II 2. Age-18-80
3. Consent toparticipate in the study
**EXCLUSION CRITERIA:**
â— Patients allergic to the local anaesthetic
â— Patients with previous history of coagulopathies/ cardiacdiseases
â— Patients with skin diseases of anteriorabdominal wall
â— Patients undergoing emergency surgery
â— Patients contraindicated for General Anaesthesia
â— Patients cleared for anaesthesia under ASA III/IV
â— Patients who underwent previous abdominal surgeries
â— Patients unwilling to participate in stud
**METHODOLOGY:**
➢ Patients attending General Surgery OPD will be included in the study based onthe inclusion and exclusion criteria.
➢ Informed and written consent will be obtained regarding participation and thepatients would be includedin the study
Ø The subjects would then beassigned to group A or group B in a randomized manner. The study subjects would then be matchedwith subjects undergoing similar procedure from the other group foranalysis.
➢ A detailed history: presenting complaints, history of presenting illness, pasthistory, history of any treatmentundertaken, personal history shall be obtained, and a detailed clinical examination undertaken.
➢ Baseline investigations: Heamatological (Complete blood count with coagulationprofile), biochemical (Liver function tests, renal functiontests, serum electrolytes), serology, blood grouping typing will be carriedout.
➢ USG/CT Abdomen/ MRCP shall be done to confirm diagnosis
➢ Cardiac assessment, anaesthetic fitness shall be obtained and then patient willbe posted for the assignedprocedure.
➢ Pre operatively, possible complications including infection, bleeding,bileleak, conversion to open surgery, shall be explained to the patient and informed, writtenconsent obtained.
➢ 0.1ml intradermal test dose of the anaesthetic is givenpre operatively
➢ 0.5ml/kg 0.5% Ropivacaine is mixed with 10mldistilled water
➢ After induction of general anesthesia, in both groups, 5ml of the diluted anaesthetic is infiltrated into the umbilical port site just before making theskin incision
➢ After insertion of this 10mm port, a pneumoperitoneum is created with pressure standardized to 12-15 mmHg for all patients.
➢ The laparoscope is inserted and generalabdominal exploration is done.
➢ For the patients in Group A, a right sided subcostal injection is given using an 22-gauge spinal needle in the mid clavicular line.
➢ Subsequent to the perpendicular insertion, localization of the needle isdetected under direct laparoscopicvision, and when the needle’s tip is positioned at the fascial space between the internal oblique and the transversusabdominis muscle, 30 cc of dilutedropivacaine is injected.
➢ Infiltration into the correct plane is confirmed by visualizing the needletraversing the extraperitoneal space without penetration of the parietal peritoneum.
➢ The needle is then withdrawn 0.5 mm and infiltration commenced.
➢ Confirmation of the corrected plan is highlighted by the presence of Doyle’s bulge, which is covered by the fibers ofthe thin transversus abdominis muscle.
➢ In both Groups A and B, 10mm epigastric port and two 5mm working ports are inserted under vision after instilling 5ml each of diluted ropivacaine locally.
➢ Post operatively, VAS (Visual Analogue Score) will be assessed at 1st hour, 4thhour, 8th hour, 16th hourand 24 hours followingsurgery for patients in eithergroup.
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➢ The patient shall be monitored for incidence of breakthrough pain (significantpain requiring the administration ofsuperadded parenteral/oral analgesics); and the dose of analgesic drug given shall be recorded
➢ The duration of hospital stay will also be recorded
➢ The data collected will then be analysedstatistically and conclusions drawn.
➢ Ropivacaine mainly shows toxicity in the cardiovascular and central nervoussystems, which will be monitored byhourly pulse rate, respiratory rate and BP charting, fourth hourlyECG monitoring and secondhourly GCS score charting.
**STATISTICAL ANALYSIS**
A descriptive statistical analysis will becarried out on the data obtainedfrom the study.
◠The resultson the continuous measurements will be analyzed and depicted as Mean ±S. D
â— The resultson the categorical data will be analyzed and presented as frequency and percentage (%)
â— Ap-value of <0.05 will be considered as significant
â— TheChi-Square/ Fischer Exact Test will be used to determine the significance ofstudy parameters on the categorical scale between two or more groups
â— Forcontinuous variables, the significance shall be determined using paired t-testor independent t-test based on parametric test
â— SPSSStatistical Package version 24.0 and Microsoft Excel will be used to computeand calculate the data
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
All patients with cholelithiasis admitted under the General Surgery department in SRM Medical College Hospital and Research Centre fulfilling the following criteria: ASA I, II Age-18-80 Consent to participate in the study.
â—Patients allergic to the local anaesthetic â—Patients with previous history of coagulopathies/ cardiac diseases â—Patients with skin diseases of anterior abdominal wall â—Patients undergoing emergency surgery â—Patients contraindicated for General Anaesthesia â—Patients cleared for anaesthesia under ASA III/IV â—Patients who underwent previous abdominal surgeries â—Patients unwilling to participate in study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post operatively, VAS (Visual Analogue Score) will be assessed at 1st hour, 4th hour, 8th hour, 16th hour and 24 hours following surgery. Post operatively, VAS (Visual Analogue Score) will be assessed at 1st hour, 4th hour, 8th hour, 16th hour and 24 hours following surgery.
- Secondary Outcome Measures
Name Time Method complications,Hemodynamics at omin,
Trial Locations
- Locations (1)
SRM Institute of Science and Technology
🇮🇳Chennai, TAMIL NADU, India
SRM Institute of Science and Technology🇮🇳Chennai, TAMIL NADU, IndiaAparna VenogopalPrincipal investigator9495208068venugopalaparna9715@gmail.com